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[QUOTE=Unregistered;296270]ASHOK BABAN SATPUTE
[b][u]Approved by FDA [/u][/b]: Capsule Manufacturing ~ Injection ~ External Preparation
 [b][u]E-Mail [/u][/b]: 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

[b][u]PROFESSIONAL ABRIDGEMENT  [/u][/b]:
** 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.

[b][u]PROFICIENCY FORTE  [/u][/b]:
** 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.

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

[b][u]LEADERSHIP AND EXPERTISE  [/u][/b]:
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
[b][u]** Work generation by self [/u][/b]: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.

[b][u]Quality Assurance/ Regulatory Testing and Inspection [/u][/b]:
** 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“.

[b][u]Process Improvement Initiatives [/u][/b]:
** 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.

[b][u]People Development [/u][/b]:
** 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.

[b][u]EMPLOYMENT CHRONICLE  [/u][/b]:
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
[b][u]Manufacturing details [/u][/b]:
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

[b][u]Key Result Areas [/u][/b]:
** 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
[b][u]Key Deliverables [/u][/b]:
** 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.
[b][u]Product Lines [/u][/b]: Tablets (Total line 5 from Day storage to compression & 3 lines of encapsulation ) &TDDS
[b][u]Machines Handled [/u][/b]: 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

[b][u]Key Result Areas [/u][/b]:
** 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.

[b][u]Project (Green field) [/u][/b]:
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)

[b][u]Projects handled  [/u][/b]:
** 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

[b][u]Key Result Areas [/u][/b]:
** 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.
[b][u]Distinctive Highlights [/u][/b]:
** 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)
[b][u]** ANDA projects handled [/u][/b]: 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.
[b][u]** Solid and Semi Solid dosage facility manages its revenue expenses with a 5% saving by [/u][/b]:
- 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.

[b][u]Audits & compliance  [/u][/b]:
** 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.

[b][u]Training achievements  [/u][/b]:
** 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

[b][u]PROFESSIONAL QUALIFICATION  [/u][/b]:
[b][u]1995 [/u][/b]: M.M.S., Pune University 1994: D.B.M., Pune University 1989: B.Pharma, Pune College of Pharmacy

[b][u]IT Skills [/u][/b]:
Well versed with Windows environment, MS – Office, Auto Cad and Internet applications
 
[b][u]PERSONAL DOSSIER  [/u][/b]:
[b][u]DOB [/u][/b]: 18th Mar, 1965; 
[b][u]Gender [/u][/b]: Male; 
[b][u]Marital Status [/u][/b]: Married; 
[b][u]Languages known [/u][/b]: English, Hindi and Marathi;[/QUOTE]

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