www.manikplacement.com Manik Placement : Roorkee

[muthukalee]

Company Name : Manik Placement ( manikplacement.com )

Company Location : Roorkee

Company Profile :
We would like to take this opportunity to introduce ourselves as H.R. & Recruitment consultants and placement services experts. We are in Technical city of new-formed state of UTTARANCHAL. This state of UTTARANCHAL is growing at a very fast pace. The State Government is highly focused on industrial and economical development of the state and is prospering because of high floating population. As can be imagined, being almost adjacent to IIT Roorkee, We’ve contacts with many skilled Technical Graduates/ Post-Graduates.

Services Offered :
H.R. & Recruitment consultants
Placement

Company Address :
MANIK PLACEMENT
Rampur Chungi, Doon School Road,
Roorkee (Haridwar) – 24766

Website : www.manikplacement.com

How to submit CV / resume : jobs@manikplacement.com

Placement Agencies Roorkee, Manpower Consultants Roorkee, Staffing Companies Roorkee

[Unregistered]

Sir i need auto cad designing job.

[Unregistered]

Ashokkumar B. Satpute
Email : absatpute10 AT yahoo.com

Assignments to head SBU Operations in the areas of Operations / Production of Injectables (Liq/Lyo), Human Insulin Biological bulk Sera, Vaccines, Toxoid ,Tablet, Capsules, Liq-Orals ,TDDS & Ext. preparations Manufacturing / Project Management / Product Development with an organization of high repute.

Executive Summary :
Results driven senior management executive with multi faceted experience of around 24 years in Pharmaceutical industry.
1 Dynamic change agent skilled in repositioning organizations to achieve operational / manufacturing excellence.
2 Presently associated with FDC Ltd. Aurangabad as Production Manager
3 Experience in production, process, Tech-transfer, product development, process optimization & control, standardizing production norms & green field projects practices involving extensive use of modern instruments.
4 Competent in manufacturing & packing of various Antibiotics, Antifungal, Anesthetic Sera, Immunizing agents Anticloting vaccines, toxoid, Proteins, Blood products & Plasma derivatives in Liquid /Lyophilized Injectables dosage forms.
5 Competent in Manufacturing of Anti sera Plasma Pheresis ,plasma processing, Tetanus toxoid non culture zone ,T.T.,DPT filling & centralized packing area.
6 Competent in manufacturing & packing of various multivitamins Antibiotics, Vitamins, ant diarrheal antacid preparations in Tablets & Capsules, dosage forms.
7 Competent in manufacturing & packing of various Antibiotics, Antifungal, keratolytic preparations in Liq-Orals ,Ointments, Creams, Lotions Liniments, Powders & Shampoos Dosage Forms
8 Competent in manufacturing and packing of various TDDS dosage forms.
9 Experience in handling of Contract manufacturing tablets, Capsules & Injectables dosage forms
10 Key member of Energy conservation & cost reduction committee.
11 Key member of Validation/Calibration & Self Inspection team.
12 Proficient in validations, qualifications, maintenance, calibration and troubleshooting of various PLC based semi auto & automatic equipments & machines of Manufacturing area, thereby enhancing productivity & quality.
13 Well versed with cGMP concept defined by Schedule M, WHO, TGA, MHRA, MCA, & USFDA.
14 Ensured compliance of various quality measures such as cGLP, cGMP, Gampa by maintenance of appropriate requisite documentation/ records & training of personnel’s.
15 Delivered dramatic breakthrough improvements towards operational excellence by leading organizations to adopt business processes improvement techniques.
16 Excellent operational/analytical, troubleshooting and inter-personal skills with proven ability in driving numerous quality enhancement, process improvement and cost savings initiatives during the career span.
17 Experience in FDA , factory Licenses, & Safety rules regulations.
18 Well versed with Environmental Control & ETP operations.
19 Register Pharmacist of “MAHARASHTRA STATE PHARMACY CONCIL” ( Registration No. 33214/2016)

Education :
1. M.M.S from Pune University in 1995.
2. D.B.M from Pune University in 1994.
3. B.Pharm from Pune College of Pharmacy in 1989.

Approved By FDA :
1. Capsule Manufacturing
2. Injection
3. External Preparation

Core Competencies :
Operations & Production Management :
1. Heading Warehouse, production operations with a view to ensure timely accomplishment of production targets within the time and cost parameters.
2. Determining the future needs and production capacity for producing required quantities of items on pre-defined standards and within financial costs.
3. Planning & implementing the preventive & predictive maintenance schedules for improving the overall reliability and safety of plant equipments.

Quality Assurance/ Regulatory Testing and Inspection :
4 Ensuring stringent adherence to quality standards, norms & practices, identifying gaps, trouble shootings and taking corrective action.
5 Handling of non compliance as per CAPA quality assurance system.
6 Ensuring compliance of various quality measures such as cGLP/cGMP/GAMP thro GEP by maintenance of appropriate requisite documentation/ records.
7 Working in close coordination in work groups & supporting departments for conducting process audits and detailing on quality requirements and finalizing the quality plan.
8 Facilitating in developing experimental & pre formulation studies of drugs and other chemicals; conducting Vendor Audits &Team member of external audits of Contract manufacturing facilities.
9 Preparation of documents, required for audit preparation for W.H.O., TGA, USFDA, MHRA,INVIMA Colombia & various MOH audits (MOH Sudan, MOH, Ghana, MOH Egypt) Hospira USA. & ISO 9002
10 Key member of PPC to fulfil the market requirements.
11 Knowledge of various regulatory guidelines & contribution in quality systems as per revised guidelines in documents preparations.
12 Work as per quality systems with strict adherence of quality documents(SOP/BMR/BPR)

Process Improvement Initiatives :
1. Identifying areas of improvement and recommending process modifications and equipment calibrations, validation to enhance operational efficiencies of machine / equipment.
2. Supervising resource planning for optimizing man & machine utilization.
3. Close control & inspection of each critical operation of manufacturing products.

People Development :
1. Setting direction, energizing, mentoring, coaching, motivating, guiding and supporting teams.
2. Developing, managing and monitoring the performance of multi-skilled large work force and conceptualizing need-based training programs for performing maintenance operations.
3. Delegating work schedules for smooth functioning of operations & leading people working at all level in an organization.
4. Training needs identification & evaluation of personnel training with the help of Training matrix.
5. Empowering & motivating subordinates to achieve the organization goal.

Organizational Experience :
** At present working in FDC Ltd. Aurangabad as Manager Production Since Nov. 2012
Company having USFDA,MHRA,MCA/ISO9002& other RWTC accredation for export
Role in FDC Ltd. :
** Planning of all production activity in plant for Ophthalmic, Powder and liquid dept.
** Responsible for delivering goods in time for all export batches (Export to UK/US/ semi regulated markets.)
** Responsible for handling of all regulatory audits like MHRA /USFDA/various customers audits, etc.
** Responsible for all production related activity likes ordering of all Production equipment, water system, stage wise inspections, installation, qualification and execution of production activity.
** Well experienced in Documentation of all activity including preparation of SOPs, BMRs, BPRs, Validation Protocol, etc.
** Well experienced in handling all Production related decisions.
** Maintaining the performance of each Production Associate and subordinate.
** Well experienced in Planning of Monthly, weekly and daily production activity and organizing requirement accordingly.
** Responsible for coordinating with other department like Quality control, R & D, Engineering, Stores, purchase, etc.
** Responsible for Manpower management and training of them for different activity.
** To check the record of S.O.P., cGMP and safety procedure.
** To check the batch wise yield achieved for each product and compare the same with standard yields.
** To carryout the validation of equipment and Area and record the same.
** Training & evaluation of shop floor personnel as regards of Machine operation, cGMP, Quality system, Documentation, etc.

** Sidmak India Ltd. Since Nov’08 Oct. 2012
G.M.Production/Warehouse/Purchase/Engineering Dehradun Uttrakhand Reporting to Director-Technical at USA
USFDA approved facility.
Role :
** Overseeing the entire operations of the Tablets, Capsules, & production of Tablets, capsules, Bottle filling of bulk pack labeling/packing & Water system including Warehouse, Production, Maintenance & Projects Department.
** Leading a team of 80 personnel’s through a team of Manager 04 & 3 Asst. Manager Production/packaging /Maintenance/ Project Ware house/Purchase & coordination with F&D ,Purchase, Regulatory & Marketing

** Bharat Serums & Vaccines Ltd. Jun’06 to Oct’08
The company having WHO, MOH SUDAN, Ukraine,EGYPT, GHANA,NIGERIA, INVIMA Colombia .
Deputy General Manager -Manufacturing-Injectable Unit
Role :
** Overseeing the entire production operations of the Inject able Unit; including production, water system , Labeling/Packaging lines, Stores & Maintenance.
** Leading a team of 70 personnel’s through a team of Manager production,03 Asst. Manager production/packaging /Stores , 3 executives 10 Production Officers of water system, Packing & Production, Stores , Maintenance & coordination with Q.C. ,Q.A. Planning, FGS Development cell ,R&D & Regulatory
** Faced the audits of TGA, MOH Egypt, MOH Sudan, MOH Ukraine , MOH Ghana, Baxter, INVIMA Colombia & HOSPIRA USA audits.
** Ensuring fulfillment of all the requirements of Schedule M of Drugs and Cosmetics Act.
** Handling installation & commencing of Freeze Dryers; qualification & validation of Freeze Dryers.
** Handling of Market complaints as per procedure.
** Training needs identification & evaluation of personnel training with the help of Training matrix.
** Preparation of budgets, WIP, APR & annual production plan & reports.
** Looking after Cyclosporine oral solution facility projects.
** Active participation , experience in INVIMA Colombia audits from 12/05/08 to 16/05/08 & got certification for products manufactured in Line 1,2 & 3
** Experience in Lyophilizer validation different product cycle setting
** Experience in QA functions like SOP preparation, Validation documents, VMP, SMF, Quality policy, TT policy, raining policy.
** Participated in Cleaning validation, Area validation, Qualification, Validation, APR preparation MPCR preparation, Preparation of various val idation protocols including process validations, Self inspection & various quality audits.
** Quality system documents preparation & training to subordinates like CCP, OSS, deviations, Validations etc.

Highlights :
** Performed FAT of Lyo-Filling & Sealing Line in Groninger at Germany.
** Participated in a 2 days seminar on Freeze Dryer at Hotel Leela by Biopharma U.K
** Participated 2 days seminar on EU/USFDA inspection requirements in Hotel Regency at Mumbai.

Project :
** Adept at planning & execution of projects for plant set up, plant expansion, modernization and installation / commissioning of equipments.
Projects handled :
1. AT RALLIES INDIA LTD. – SVP WHO products
2. AT CIPLA LTD. – a) Goa Liquid/Lyophilized injectables & Dry powder for USFDA products.
3. AT BHARAT SERUMS & VACCINES LTD. –Cyclosporine Liq-Orals.

Knowledge Purview :
** Installation, qualification/validation & operation of PC & PLC based Freeze Driers e.g. Terruzzi, TLC 150 CS, VIRTIS Ultra 35 Martin Christ 65DS & 160DS.
** Installation & Operation of Ultra filtration, ROEDI & Multieffect still (PSG+WFI) of Christ Nishotech & Aqua nova.
** Installation, Validation & operation of Vial Washing Filling/Sealing Groninger Line.
** Installation, Validation & operation of Fedegari Steam Sterilizer cum Bung Processor
** Procurements of equipments m/c preparation of qualification records & reviewing of validation documents for new facilities.
** Installation, Validation of Optimize Transdermal M/C for patches.
** Setting, qualification, operation of various M/C from conceptual drawing to commercial batch production.
** Process optimization & validation in PASK I.V product in Tefflon make Lyophilizer.
** Installation, validation & operation of LSI make lyophilizer.
** Installation, validation & operation of 52 st. Camack Compression M/C
** Installation, Validation & operation of Auto coater 60” PAM GlLATT
** Installation, qualification & operation of Extruder of Japan make
** Installation ,qualification & operation of Fully automatic bottle washing to induction sealing m/c of Countec make of Germany.
** Installation, Validation & operation of 45 st. Cadmak compression M/C.
** Installation ,qualification / validation & operation of various M/C/Equipments in Granulation area including VTS.(RMG, FBD, Paste kettle, Conta/V blender 10Cu. Ft & 20Cu. Ft.)
** Temperature mapping of area suit the environmental monitoring requirements.
** Handling of BMS system for environmental monitoring & controls.
** Process validation & ANDA batches of various products.
** Attained training on 21 CFR cGMP External training by Mr. Atul Shirgawkar Technical consultant. (5 days 20-12-2010 to 24-12-2010)
** Attained External training of 21 CFR USFDA on six systems of USFDA audits delivered by Dr. Bauokhandi as Technical consultant of GMP Pharma. Inst. Pvt. Ltd from Jan.2011 to Aug. 2011)

** M/s Cipla Ltd., Goa Unit V & IX
Production Head Injectable Unit
Sep’04 to May’06
The company having WHO, USFDA, MHRA, & TGA Approvals.
Role : Managing a gamut of activities

From March 2004 : Working as Production Head at Cipla Goa M/s Oncocare Unit No. V
1 Made the production related documents and faced the USFDA audit.
2 Documents related to USFDA UNICEF MHRA,MCA TGA &various MOH Audits
3 Working with team of 28 production (Management and Operating) staff to achieve the monthly production schedule and achieving the production target.
4 Planning of the production schedule. Coordinating with planning, Export department for completing the production targets.
5 Review and updation of all the production documents to meet the current cGMP requirements or based on GMP Trends and regulatory inspection compliance.
6 Preparations of Batch manufacturing records, SOPs, Qualification documents.
7 Completed the installation of the Imported complete vial line (Washer, Dehydrogenating Tunnel, filling & sealing machine) from M/s Groninger GmbH. And also knows the operating knowledge.
8 Done the startup validation of the area and the equipments.

Worked on M/s Klenzaids filling line knows the operation and maintenance knowledge of Multicolumn distilled water plant, Pure Steam generator, SEPTRON Purified water generation system from M/S Christ Germany (1000 LPH). Knows the operating knowledge of the Freeze Dryer from M/s Christ Germany having 65 Kg ice condensing capacity.
Freeze Dryer :
1 Preparation of URS & forwarding to different suppliers
2 Comparison of FDS received from Suppliers.
3 Selection of Lyophilizer with techno commercial comparison
4 Reviewing of FAT protocols of Supplier as per cGMP
5 Installation & qualification of Freeze dryers
6 Involved in validation of Lyophilizer CIP,SIP,Cycle development
7 Development of Lyophilization cycle in consultation with R&D
8 Training of subordinates on Lyophilization operation & maintenance
9 Media filling, process validation & commercial production in lyophilizer
10 Revalidation of lyophilizer as per schedule

Contract Manufacturing :
1. Preparation of quarterly rolling plan in consultation with Material & marketing Department.
2. Schedules for the RM/PM
3. Release of RM/PM
4. EOQ of Excipients/less value items
5. Preparation of production planning
6. Monitoring of Manufacturing/packing & dispatches of products n time in coordination with contract manufacturing units to marketing.

Duties & Responsibility : Monitoring and controlling the production activity, co-ordination with planning & export coordination department fulfilling the export and local market requirement . Audit preparation and compliance of the audit points. Training to the staff. Manpower management . New product development trial with the help of R & D

Heading the department.
Facility projects for Liquid/Lyophilized products & Dry syrup at Unit IX active involvement from conceptual drawing to commercial batch production.

Highlights :
1 Successfully completed the ANDA registration batches of Granisetran Injection & Insulin of different strength in 2005.
2 Successfully completed the ANDA registration batches of Minocycline hydrochloride all 5 strengths, Trospium & Nitrofurantoin.
3 Successfully completed the ANDA registration batches of Acetozolamide ER capsules.
4 Handled installation of imported complete vial line (Washer, Dehydrogenating Tunnel, filling & sealing machine) from M/s Groninger GmbH.
5 Independently handled Unit IX Liquid & Lyophilized Injectable Project.
6 Products handled both Lyophilized and Liquid Inject able in Cipla at Unit V & IX.
7 Set up & preparation of OSD plant readiness for USFDA

Unit IX :
Liquid Injectables : Insulin Injection & Granisetran Injection
Lyophilized Injection : Antibiotics,Rabeprazole Injection, Azitrhomycin 500 Injection, Tecoplanin Injection 200 & 400, Omeprazole Injection

Achievements :
1. Control of weight variation in capsules with adequate in process controls.
2. Manufacturing of bulk with respect to capacity of lyophilizer to meet the cGMP requirements.
3. By strict monitoring & control reduced the ampoule breakages in terminal sterilization to improve the yield by 2% in Rallies india /Bharat serums & vaccines Ltd.
4. Cost saving in QC sample by increasing the batch sizes of products.
5 Initiator for the camp ion runs of products for adequate utilization of facilities in Shreya & Bharat serums Ltd.
6 Lyophilization cycle reduction in Shreya Life Science & Bharat Serums Ltd. by 3 hrs in Sec. Drying by increasing the temp. from 25 Deg. to 35 Deg.
7 Member of Energy Conservation in Shreya Life Sc. & Cipla Ltd.
8 Cost reduction of consumables & stationeries by closely monitoring & controlling the issues.
9 Reduced factory overheads from 25 L to 15 .0L in Sidmak Laboratories Pvt. Ltd.
10 Reduction of rejection at various stages of production &improved yield of products by 1 to1.5%
11 Reduced C/O & down time of machines & equipments by planning , interdepartmental co-ordination & maintaining critical spares of M/C & equipments as per suppliers recommendation.
12 Target production by use of available resources & 5% net saving on Capital budgets of Departments.
13 Yield improvements by carefully studying each operation as a unit operation & minimizing rejection at various stages of production.
14 Plant made US FDA compliance within 2years (Sidmak Laboratores.Pvt. Ltd. )of joining. Preparatory work includes project finishing, Ordering and installation of equipments and related documentation like URS, DQ, FAT, IQ, OQ and PQ.
15 Proposed and implemented various significant cost improvement ideas in Sidmak Labs. Ltd.
16 Technical trouble shooting in various areas to avoid the noncompliance.
17 Successful audits faced in FDC Ltd. UKMHRA / various customer audits like/Apotex Pharma/ ISO
18 Suggested the changes in facility design to minimize the movement of material

AUDITS FACED :
1. US FDA
2. MHRA
3. WHO (GENEVA)
4. WHO
5. MCC
6. TGA
7. Various audits from African/Middle east countries and Non- regulated markets.
8. Customer Audits from various countries.E.g. Baxter
9. ISO audits.

Previous Assignments :
M/S FDC Ltd. Prod. Manager Nov. 2012
M/S Sidmak Labo. Ltd. GM-Prod. Nov.08 to Oct.2012
M/S Bharat Serums & Vaccines Ltd DGM-Manufacturing Jun’ 06 to Oct’08
M/S Cipla Ltd. Goa Head Production Sept’04 to May’ 06
M/s Shreya Life Sciences Asst. Manager-Production Nov’97 to Aug’04
M/s Emcure Pharma, Pune Production Executive Dec’94 to Oct’97
M/s Serum Institute of India Ltd., Pune Production Officer Apr’91 to Nov’94
M/s Litaka Pharma, Pune Production Supervisor Jul’89 to Apr’91

Extra Curricular Activities :
1 Participated actively in Community Social Work.
2 Participated and completed The Pune International Marathon, Cross Country and other events.
3 Completed Memory development work shop for 7 days in Aurangabad & Mumbai.
4 Participated actively in 2 dyas workshop on Cross functional team discipline YMCA Mumbai.
5 Participated & completed 7 days Memory developments & meditation course at Aurangabad.

Personal Details :
Date of Birth : 18th March 1965
Passport : Earlier expired hence applied
Nationality : Indian
Present CTC : 1300000 per annum(Includes 3,70,000 reimbursement/voucher payment like Petrol, Car, books, Servant allowances +PF contribution +Petrol at actual) Accomodation & mobile free
Location : Aurangabad
Expected CTC : Negotiable

[Unregistered]

Administration Manager – P&A Management with 15+ Years of qualitative Experience in Site Administration.
Construction - Oil and Gas, Power and Energy, Wind Energy, Refinery and Petrochemicals, Civil-Mechanical-Electrical- Infra/ Const.Projects with Specialization in-
Administration - Lab our Management - Staff Talent Management and Appraisal- Facility Management- Liasoning with Client/Consultant.HSE Management-Vendor/Transport Management- Planning & Co-ordination. Safety and Security Management. Labor Laws and Implementation etc.
Also working Experience as an Administrator with US. Military in Afghanistan.

Presently associated with Indian Based Company-Angelique International Ltd. Posted its Project Site at Congo-West-Africa as an Administration Manager

A Strategic thinker with a flair in handling the Client and building good relationship while handling the Project Activities. Expertise in handling Admin activities involved right from Project opening to Closure. Possess excellent interpersonal, analytical, troubleshooting and team building skills with proven ability in establishing quality system / procedures and planning / managing resources.

Skills/Qualifications : Tracking Budget Expenses, Staffing, Quality Management, Managing Processes, Organization, Coaching, Communication Processes, Disciplining Employees, Motivating Others, Promoting Process Improvement, Reporting Skills

PROFESSIONAL EXPERIENCE :
15+ years in Site Administration and Management with Commercial Activities
Designation : Administrator/Administration Manager.
Company : Angelique International Limited-Africa.
Industry : Power and Energy.
Duration : Jan-2013 to Present

Designation : Administrator
Company : GRRL.LLC. - Dubai. Afghanistan under US Army.
Industry/Service : Administrative Support to US. Army-Afghanistan.
Duration : May-2011 to 30th Dec-12.

Designation : Administration Manager.
Company : DSC.Ltd. Libya- North Africa.
Duration : Jan-2011 to March-2011.
Industry : OIL AND GAS. (Due to Civil War in Libya Returned to India).

Designation : Administration In charge. (On-Contract)
Company : Thermax Instrumentation Ltd. – India.
Duration : Jan-2010 to Dec-10
Industry : Power and Energy Projects.

Designation : Sr. Executive Administration/Commercial.
Company : Siemens Ltd- India.
Duration : March-2004 to Dec-2009.
Industry : Oil & Gas with Power and Energy Projects.

Designation : Administration/ Commercial. Executive
Company : Prefab Systems.
Duration : July-2000 to Feb-2004.
Industry : Civil Infra. Under UNICEF

Designation : Accounts/Admin Officer (Projects)
Duration : April’1994 to June’2000.
Company/Industry : VTV Ltd. India - Oil and Gas Projects.

From Jan-2013 to Present.
Working with Indian Based Company Angelique Intl. Ltd. Posted its Project Site in DR.Congo-West Africa as an Administration Manager.

Duties & Responsibilities :
Assisting in managing all the activities of the administration department and supervising staff on daily basis.
Handling Labor Compliance and looking the statutory requirements as per the Indian/Overseas Labor Act.
Liasioning with other divisions in the group to assist them in their requirements.
Manage company office support services, property, assets, files, housing, facilities, and transportation.
Supports several departments within the organization or company and provides support for any and all projects.
Knows the Company’s health, safety, and environment policy, procedures, regulations and objectives as they relate to his area of responsibility and ensure that they are effectively implemented in his domain. Ensure by appropriate monitoring and review, the work under his control is performed in a safe and follows up.

** Ensure that the contractors are fully compliance with the HSE policy and procedure.
Supervise and ensure general administration activities like Telecommunication Facilities, Mess, Transportation, Housekeeping and Maintenance, Stationary, Power, Water and uninterrupted supply of essential services etc.
Plan and initiate actions for accommodation requirements as per the Project Manpower Histogram provided by the Project Management.
To manage the fleet of company owned vehicles and supervise for smooth functioning and resolving issues related to transport, repair & maintenance and detailing of company owned vehicles for day to day operations of the Company.
Carry out all maintenance requested on time to facilitate a better and proper use of all facilities and common areas and schedule housekeeping services with a view to maintain safe and healthy environment. Participate in periodic walkthrough with HSE staff and paramedic and take a note of points for necessary corrective action.
To facilitate setting up of new site offices and camps, , internal infrastructure modifications, electrification, air conditioning, furniture, etc. and asset management.
Maintains administrative staff by recruiting, selecting, orienting, and training employees; maintaining a safe and secure work environment; developing personal growth opportunities.
Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures. Achieves financial objectives by anticipating requirements; submitting information for budget preparation; scheduling expenditures; monitoring costs; analyzing variances. Maintains continuity among corporate, division, and local work teams by documenting and communicating actions, irregularities, and continuing needs. Contributes to team effort by accomplishing related results as needed.
Initiate Counseling / Disciplinary actions whenever required for workers and staff, ensure prompt resolution of employee grievances to maintain cordial management-employee relations.
Maintaining Pay-Roll and Staff Talent Management and Appraisal
Full & Final Settlement
** Managing accurate & timely Full & Final of employees.
** Maintaining the record of the same
** Grievance handling
** handling the exit formalities of the employees.

Educational Qualification :
Master Degree-Accounts and Administration-Agra Unversity-1989-India
B.Com from Agra University (1987) - (Graduate) - India
Intermediate from U.P Board (Allahabad) - India
High School from UP Board (Allahabad) - India

Personal Information :
Name : ShashiBhushan.S.Prasad
Nick Name : Shashi Prasad
Date of Birth : 23.02.1965
Father’s Name : Late.MSP.Mahatha.

Shashi Prasad.

[Unregistered]

ASHOK BABAN SATPUTE
Approved by FDA : Capsule Manufacturing ~ Injection ~ External Preparation
E-Mail : absatpute10 AT yahoo.com, absatpute10 AT gmail.com

OPERATIONS & PRODUCTION MANAGEMENT ~ QUALITY ASSURANCE / REGULATORY TESTING & INSPCTION ~ PROCESS IMPROVEMENT PROFESSIONAL
A motivated and results-focused professional, seeking an opportunity to utilize career experience, skills and education to contribute to employer objectives, profitability and success in the domain of Pharma formulation industry

PROFESSIONAL ABRIDGEMENT :
** An astute and strategic professional, offering a productive experience of 24+ years in the gamut of SBU Operations in the spectrum of Manufacturing operations / Production of Sterile/Ophthalmic, Injectables (Liq / Lyo), Human Insulin Biological/Blood products (bulk Sera, Vaccines, Toxoid) OSD, Liq-Orals, Ext. preparations & TDDS, Manufacturing / Project Management / Product Development.
** A qualified professional, competent in manufacturing & packing of various dosage forms like Sterile/Ophthalmic, Injectables (Liq / Lyo), Biological/Blood products (bulk Sera, Vaccines, Toxoid) OSD, Liq-Orals, Ext. preparations & TDDS; currently spearheading efforts as Production Manager in Sterile Opthalmic, Liquid-Orals & Powder with FDC Ltd., Aurangabad.
** Possess an attitude of go-getter coupled with multi–tasking abilities in driving team efforts towards achievement of organizational goals with efficient skills.
** Excellent time management skills with proven ability to work accurately and quickly prioritize, coordinate and consolidate tasks; resilient with a high level of personal integrity and energy experience.

PROFICIENCY FORTE :
** Recognized as a proactive individual who can rapidly identify problems, formulate tactical plans, initiate change and implement effective strategies by ensuring compliance of various quality measures such as cGLP, cGMP, Gampa by maintenance of appropriate requisite documentation/ records & training of personnel’s.
** Demonstrated excellence in production, process, Tech-transfer, product development, process optimization & control, standardizing production norms & green field projects practices involving extensive use of modern instruments in Sterile/Ophthalmic, Injectables, OSD, Ext. prep. &TDDS dosage forms while achieving continuous growth.
** Proficiency in Commissioning, Installation qualifications, validations, maintenance, calibration and troubleshooting of various PLC based semi auto & automatic equipments & machines of manufacturing area, thereby enhancing productivity & quality.
** Well versed with GMP/ cGMP& Safety concept defined by Schedule M, WHO, TGA, MHRA, MCA, ICH, USFDA& various MOH/ISO; Environmental Control & ETP operations respectively.
** Comfortable interacting with multiple levels of organization, management and staff; Proficient in developing & streamlining systems with proven ability to enhance operational effectiveness and meet operational goals within the cost, time & quality parameters.

Soft Skills :
Analytical Skills - Organizational Skills - Man Management - Coordination Skills - Time Management - Monitoring Skills - Interpersonal Skills - Problem detecting & solving Skills - Leadership Qualities - Managerial Attitude

LEADERSHIP AND EXPERTISE :
Operations & Production Management
** Heading Warehouse, production operations with a view to ensure timely accomplishment of production targets.
** Determining the future needs and production capacity on pre-defined standards and within financial costs.
** Planning & implementing the preventive & predictive maintenance schedules for improving the overall reliability and safety of plant equipments.
** Promoting & helping the peers in process simplification and upgrading them with latest technologies
** Work generation by self :30%,bySuperior :10%,by:Peers:10% & by: Subordinates 50%
** Aligning business plans with overall manufacturing requirements.
** Strong pharmaceutical manufacturing background (especially aseptic/lyophilized/biological processing)
** Driving the improvement projects using Business Excellence Tools.
** Handled production volume of 180 to 200millions tablets/capsules with5 granulations,1 dry granulation5 45 st. compression Cad mach compression m/c & one 37 st. ,5 nos. of coating area(Garson/Pharmaglatt /Sams Auto coater),5 Nos. of blister m/c,4 nos. of strips packing along with fully automatic bottle filling/sealing/labeling countec line.
** Injection volume of 0.95 to 1.5 million with sophisticated automated systems along with PAT applications(Ampoule/ vial washing/ tunnel/ autoclave/ filling/ lyophilizer/ sealing & leak testing machines)
** Ointment volume of 80 lacks to 1.2 Cr. With use of automated M/Cs/equipments.
** Worked in different environment organization from middle scale to large with regulatory GMP compliance.
** Facilitating in developing experimental & pre formulation studies of drugs and other materials; conducting Vendor Audits &Team member of PPIC, external audits of Contract manufacturing facilities.
** Continuous improvements & up gradation of equipments & facility according to cGMP/Safety/project & Regulatory requirements.

Quality Assurance/ Regulatory Testing and Inspection :
** Ensuring stringent adherence to quality standards, norms, practices, identifying gaps, trouble shootings and QMS & also to maintain the all related documents.
** Practicing quality system standards with improving quality & opportunities.
** Handling of non compliance as per CAPA/OSS/Deviations as per quality system in various dosage forms.
** Ensuring compliance of various QS measures cGLP/ cGMP/ GAMP thro GEP with documentation/ records.
** Preparation of documents, required for audit preparation for W.H.O., TGA, USFDA, MHRA, INVIMA Colombia & various MOH audits (Sudan, Ghana, Uganda, Kenya, Cuba & Egypt) as well as buyers audits like Perrigo, Carreco, Apotex, Hospira USA. & ISO 9002
** Knowledge of various regulatory guidelines & contribution in QS for documents preparations.
** Maintaining all the time readiness in terms of regulatory compliance/Audits.
** Adequate training to all employees as per Training calendars, review, evaluation & if required corrective action.
** Carrying out investigation, identifying root cause & completion of CAPA.
** Handled 4 quality systems as per 21 CFR compliance, successfully faced & passed the USFDA audits.
** Assurance of quality at each stages of Manufacturing & following the concept of “Building quality during production“.

Process Improvement Initiatives :
** Tablet manufacturing process from dry/ wet mixing to bulk/blister/strip packing with initiation of process validations & in sterile / Injectables inputs for the lyo cycle reduction.
** In capsule manufacturing introduction & implementation of Wet granulations in various antibiotic preparations
** Identifying areas of improvement and recommending process modifications and equipment calibrations, validation to enhance operational efficiencies of machine / equipment.
** Supervising resource planning for optimizing man & machine utilization.
** Close control & inspection of each critical operation of product manufacturing.
** Along with day to day production always keeping short-term & long term targets for achievements.

People Development :
** Developing, managing and monitoring the performance of multi-skilled large work force and conceptualizing need-based training programs for performing maintenance operations.
** Delegating work schedules for smooth functioning of operations & leading people working at all level in an organization.

EMPLOYMENT CHRONICLE :
FDC Ltd., Aurangabad Manager Production Since Nov’12
Reporting to Works Manager

Company having USFDA, MHRA, MCA / WHO/MOH &Buyers auditsISO9002 & other RWTC accreditation for export/Domestic Manufacturing
Manufacturing details :
Opthalmic Department with 3 lines from Day stores to final packing with twoBFS M/C’s & one BFS m/c’ with insert Capacity 55Lacs vials/month
Powder department with two sections external &Oral section with 4 lines from Manufacturing to final packing capacity 45Lacs sachetsper month
Liq-Oral Department two lines from day stores to final packing with capacity 10Lac’s bottles per month.
** Led a team of 350 personnel’s through a team of Manager production, 6 Asst. Manager production / packaging / Stores , 6 executives 20 Production Officers & 30 nos.of Prod. Supervisors Warehouse to final packing of all 3 departments. & in co-ordination with Q.C. ,Q.A. Planning, FGS Development cell ,R&D & Regulatory

Key Result Areas :
** Production planning, monitoring & control.
** To ensure strict adherence to GMP/ cGMP /Regulatory, Safety & project requirements of Plant/Organization.
** Co-ordinations with other section/departments/units/Suppliers/others vendor activities.
** Auditing an existing system/process/documents & procedures measures to correct the gaps in line with regulatory expectations
** Preparation, review & verification of Department & cross functional departments documents as per QMS.
** Responsible for delivering goods in time for all export batches (Export to UK/US/ semi regulated markets.)
** Responsible for handling of all regulatory /domestic audits.
** Responsible for all production related activities, ordering of all related equipment/ M/ cs, stage wise inspections, installation, qualification and execution.
** Handle all Production related decisions.
** Maintaining the performance of each Production Associate and subordinate.
** Responsible for Manpower management and training of them for different activity.
** Preparation, review, verification, approval of documents & strict implementation as per QMS.
** All the deviations are reported, evaluated and the critical deviations are investigated & recorded.
** To carry out the validation of equipment and Area and record the same.
** Vendor management based on feedback% rejections, quality improvement rate & timely delivery of materials.
** Accountable for planning,/execution, review, approval of documents, manpower, budget control & Regulatory/GMP audits and compliance.
** Responsible for the each machine/equipment in operation, appropriate process validation, revalidation/requalification & calibration of equipments/machineries / instruments located in Departments.
** Responsible for scrap control & disposal..
** To carry out any other job responsibilities assigned by superior & top management.

Sidmak India Ltd., Dehradun, Uttrakhand Nov’08 – Oct’12
G. M. Production / Warehouse / Purchase / Engineering; Reported to Director-Technical at USA
Key Deliverables :
** Overseen the entire Manufacturing operations & production of Tablets, capsules, Bottle filling of bulk pack labeling/packing & Water system including Warehouse, Production, Maintenance and Projects Department.
** The prime responsibility to support and supervise the manufacturing operations of the plant.
** Responsible and accountable for all activities related to plant including production, Store, HR, safety, security, accounts and other support functions. To coordinate with corporate in all respect and implement corporate policies.
Product Lines : Tablets (Total line 5 from Day storage to compression & 3 lines of encapsulation ) &TDDS
Machines Handled : Conta Blender, RMG, FBD, CADPRESS IIA 45,37Stations, PAM ACG AF-25T,90T,Autocoater-Gansons36’’, PAM GLAT 60’’, Blister machine-Elmach 2000, Gansons strip seal machine-4, 12 track, Alu / Alu Rapid pack, Countec Bottle filling & sealing and Labeling with Maharishi labeling machine Pellets-pellet / Tablet-pellet, Tablet/tablet Encapsulation technology, sustained released pellets technique on Conventional pans etc.
** Enhanced the productivity/yield improvement of Tablets & capsules.
** Manufactured Tablets/capsules for Glaxo/Burrows welcome/HCiba/Serum/Micro/DRL/Abbott/Perrigo
** Handled entire gamet of Tablets/Capsules from Granulation to packing & from ANDA batch manufacturing to commercial export to US.& other markets.

Bharat Serums & Vaccines Ltd. Jun’06 to Oct’08
Deputy General Manager –Manufacturing - Injectable Unit Reporting to Plant Head
The company having WHO, MOH SUDAN, Ukraine, EGYPT, GHANA, NIGERIA, INVIMA Colombia

Key Result Areas :
** Led a team of 70 personnel’s through a team of Manager production, 3 Asst. Manager production / packaging / Stores , 3 executives 10 Production Officers of water system, Packing & Production, Stores , Maintenance & coordination with Q.C. ,Q.A. Planning, FGS Development cell ,R&D & Regulatory
** Faced the audits of TGA, MOH Egypt, MOH Sudan, MOH Ukraine, MOH Ghana, Baxter, INVIMA Colombia and HOSPIRA USA audits.

Project (Green field) :
Adept at planning & execution of projects for plant set up, plant expansion, modernization and installation / commissioning of equipments.(From conceptual design to commercial batch production)

Projects handled :
** AT RALLIES INDIA LTD. – SVP WHO products
** AT CIPLA LTD. – a) Goa Liquid/Lyophilized injectables & Dry powder for USFDA products.
** AT BHARAT SERUMS & VACCINES LTD. –Cyclosporine Liq-Orals.

M/s Cipla Ltd., Goa Unit V & IX Production Head Injectable Unit Sep’04 - May’06 The company having WHO, USFDA, MHRA & TGA Approvals
Cipla Goa M/s Oncocare Unit No. V Production Head Mar’04 – Sep’04 Reporting to Factory Head

Key Result Areas :
** Made the production related documents and faced the USFDA audit.
** Documents related to USFDA UNICEF MHRA, MCA TGA & various MOH Audits

Freeze Dryer
Preparation of URS / FDS / Techno commercial comparison, raising PO follow up to party, Reviewing of FAT protocols as per cGMP requirements, Commissioning / installation / qualification / validation & operations of Lyophilizer.; Development of Lyophilization cycle in consultation with R&D

Work experience in Contract Manufacturing of OSD, Sterile products from planning to dispatch.
Distinctive Highlights :
** Performed FAT of Lyo-Filling & Sealing Line in Groninger at Germany.
** Participated in a 2 days seminar on Freeze Dryer at Hotel Leela by Biopharma U.K
** Participated 2 days seminar on EU/USFDA inspection requirements in Hotel Regency at Mumbai.
** Successfully completed the ANDA registration batches of Granisetran Injection & Insulin in 2005.
** Visited ACHEMA international exhibition on pharma equipment & Machinery in Germany (15.04.06 to 19.04.06)
** ANDA projects handled : a) Granisetran Injection b) Trospium TR218 c) Minocycline Hydrochkiride all 8 strength 45/55 mg /65/80/90/135mg) d) Acetozolamide ER Capsules e) Disulfiram tablets f) Nitrofurantoin Capsules etc.
** Handled installation of imported complete vial line (Washer, Dehydrogenating Tunnel, filling & sealing machine).
** Independently handled Unit IX Liquid & Lyophilized Injectable Project.
** Products handled both Lyophilized and Liquid Inject able in Cipla at Unit V & IX.
** Set up & preparation of OSD plant readiness for USFDA

Achievements (Cost reduction without affecting the SISPQ of product)
** Control of weight variation in capsules with adequate in process controls.
** Manufacturing of bulk with respect to capacity of lyophilizer to meet the cGMP requirements.
** Reduced the ampoule breakages in terminal sterilization and improved yield by 2%.
** Approvals in Injectables, Ext. preparations & Capsules by Maharashtra FDA.
** Part of Energy Conservation Team and reduced the energy cost for the HVAC, electricity and Water systembill by2% from total billing amount by running most of energy consuming activites in Zone III.
** Solid and Semi Solid dosage facility manages its revenue expenses with a 5% saving by :
- Saving In Consumables over by 5% ** Reduction in rejection losses by 0.5 %
- Other Semi Variable like Tele, fax, transport, travel etc costs by 10%.
** Reduced C/O & down time of machines & equipments by planning, interdepartmental co-ordination & maintaining critical spares of M/C & equipments as per suppliers recommendation. (Reduction in C/O by 3%)
** Reduced factory overheads from 25 L to 20L by reduction of rejection & improved yield of products by 1 to1.5%
** Target production by use of available resources & 5% net saving on Capital budgets of Departments.
** Worked in Biological/Blood products/enzymatic/OSD, Ext. prep. &TDDS dosage forms

Yield & time frame
** Achieved a minimum 5% reduction in daily contract manpower.
** Achieved 85 to 90% plan compliance every month for Domestic & US or EU markets.
** Achieved US batches Order Compliance to be within timeframe, with respect to committed.
** Achieved 90 to 95% compliance for ANDA batches on monthly basis in Cipla/ Sidmak & FDC.
** Achieved an average of 90 to 94% of the committed plan, in other Co-market in product & value terms.
** Achieved work station productivity equal to or more than 75 to 80%.
** Achieved productivity on average basis Mfg Manpower 15 to 20% & Packing Manpower 50 to 55%
** Increased outputs, yields and decrease down times in Manufacturing and Packing of OSD & Sterile products.
** Reduced the cycle times of processes which are bottlenecks to increase overall capacities E.g. Lyophilization cycle reduction by 3hrs. in Sec. Drying by increasing temp from 25 to 30Deg. C.
** Reduced rejection & increase in yield by 1% in OSD & Sterile products.

Audits & compliance :
** Continuation of Regulatory status (USFDA, ANVISA, MCC, TPD, and WHO GMP) for Sterile/OSD products.
** Faced various regulatory/ Domestic audits &active participation in compliance of same.
** Achieved 90 - 95% compliance for line clearance & documentation in process area of OSD & Sterile products.
** Regulatory audits experience & exposure.
- WHO Geneva audits in Serum Institute of India
- WHO & ISO audits in Emcure Pharma
- USFDA /MHRA /TGA /MCC re-audits in Cipla Ltd.
- Hospira US audit in Bharat serums & Vaccines Ltd.
- TGA pre-audit in Bharat Serums & Vaccines Ltd.
- INVIMA Colombia in Bharat serums Ltd.
- USFDA & various customer audits in Sidmak Labs Ltd.
- MHRA /WHO/ISO/UGANDA audits in FDC Ltd.
- Various MOH audits like Sudan/ Ghana/ Colombia/ Ukraine etc.

Training achievements :
** Training evaluation & certification of employees in Induction/Basic/ On the job/ GMP/ cGMP/ GDP/ Safety/ Project/ Validations/Qualification & also periodical training as per calendar as per QMS.
** Attended various training conducted by external trainer on cGMP/ Personality development/ Regulatory/Support of cross functional department / Meditation for Productivity improvement & implementation of same on shop floor.
** Attained training on 21 CFR cGMP by Mr. Atul Shirgawkar Technical consultant. (5 days 20-12-10 to 24-12-10)
** Attained training of 21 CFR USFDA on six systems of USFDA audits by Dr. Bauokhandi of GMP Pharma. Inst. Pvt. Ltd from Jan.2011 to Aug. 2011) and implementation of same to meet regulatory compliance.
** Preparation of documents,daily cGMP rounds,performance of critical checks & on line documentation to meet the cGMP requirements
** Attainded external/internal training on UK MHRA orange guidline
** Successfully completed external training of 6 systems as per 21 CFR of USFDA for 6 months & hence assurance of compliance against regulatory audits.
** Plant made US FDA compliance within 2years (Sidmak Laboratores. Pvt. Ltd.) of joining. Preparatory work includes project finishing, Ordering and installation of equipments and related documentation.

M/s Shreya Life Sciences Asst. Manager-Production Nov’97 - Aug’04
M/s Emcure Pharma, Pune Production Executive Dec’94 - Oct’97
M/s Serum Institute of India Ltd., Pune Production Officer Apr’91 - Nov’94
M/s Litaka Pharma, Pune Production Supervisor Jul’89 - Apr’91

PROFESSIONAL QUALIFICATION :
1995 : M.M.S., Pune University 1994: D.B.M., Pune University 1989: B.Pharma, Pune College of Pharmacy

IT Skills :
Well versed with Windows environment, MS – Office, Auto Cad and Internet applications

PERSONAL DOSSIER :
DOB : 18th Mar, 1965;
Gender : Male;
Marital Status : Married;
Languages known : English, Hindi and Marathi;