www.glenmarkpharma.com Glenmark Pharma Ltd Mumbai : Corporate Quality Assurance

[mskavi]

Glenmark Pharmaceuticals Ltd Mumbai : Corporate Quality Assurance
Website:http://www.glenmarkpharma.com
glenmarkpharma.com

Job Title : Officer / Executive - CQA (Artwork) (GGL)
Location : Mumbai (Corporate Office)
Functional Area : Quality
Sub Functional Area : Corporate Quality Assurance
Job Type : Full Time
Job Description : 1. Art work review and approval for co-marketing products manufactured at different locations.
2. To prepare and update file of current, approved art work location wise for Co-Marketing locations.
3. Preparation, issuance and retrieval of Raw Material, Finished Product Specifications and Standard Test Procedures.
4. Preparation of validation protocol and reports for new products and new location transfer product.
5. Routine updating of documents.
6. SAP BOM updating and review.
7. License Documents review.
8. Maintenance of different logs (Deviation, Change Control, Market complaint) and documents.
9. Assurance over the finished products release from contract locations by reviewing COA against specifications & coordinating with location for any abnormalities such as OOS, OOT.
10. Preparation and review of BMR and BPR brand wise.
11. Review and tracking of the product related deviations and change controls at co- marketing locations.
12. Compilation and review of Stability study data of product batches manufactured at Co-marketing locations.
13. Review and maintenance of MFR’s for new and existing products.
14. Updating of file of current packing material specification.

Experience : 2 - 6 Yrs.
Under Graduate Qualification : B.Pharm, B.Sc,
Post Graduate Qualification : None,
Other Qualifications : SAP Knowledge
Age : 25 - 30 Yrs.

Apply online

[Guest]

RESUME

PATWA ATUL VIJAYKUMAR
Email Id : atul.4291 AT rediffmail.com

EDUCATIONAL QUALIFICATION :
- M.Sc. Organic Chemistry PUNE University,
(Mar.2002)
- B.Sc. (Chemistry) PUNE University,
- H.S.C. from Pune Board,
- S.S.C Pune Board
COMPUTER SKILL :
- Computer Operating Basic Knowledge.
- Well versed with internet.

JOB EXPERIENCE :
- Working as a corporate quality assurance officer (CQA-Officer) in Sharon bio-medicine Vashi (Navi Mumbai) from 6 July to till date.
- Worked as quality control chemist in Marksans Pharmaceuticals Ltd. (FORMELY GLENMARK) Verna, GOA from 6 FEB. 2008 to 5 July 2009.
(From 2002 to 2007 I am worked in teaching field)
- HANDLING OF INSTRUMENTATION :
- UV Visible spectrophotometer ( Shimadzu )
- Karl FischerTitrator ( Labindia )
- pH Meter (Labindia)
- I.R. Spectrophotometer (FTIR-IR Jasco)\
- Melting Point (Labindia )
- High Performance Liquid Chromatography ( DIONEX)
- Hardness tester
- Dissolution Apparatus (Labindia)
- Density Meter ( LabIndia )
- Disintegration Apparatus(Labindia)
- Friability tester-
- Quality control inprocess and finished testing for tablets,softgel, hardgel caplets.

JOB RESPONSIBILITIES :
- To prepare Specifications & Standard test Procedures of Raw Material & Finished Product in compliace with Regulatory requirements.
- To review Specifications & Standard test Procedures of Raw Material & Finished Product and issue controlled copies to concern.
- To draft text matter and check artworks of all printed packing materials as per legal/ regulatory requirements.
- Arrange & carry out Vendor Audits for Raw Materials & Packing Materials as per schedule. Prepare reports & ensure compliance with Audit report.
- To prepare Master Product Files of each Product of Sharon and products manufactured on contract basis. (Master product file contains – The Current master copy of documents like Art work, BOM, MFR, MPR, Spec & test procedures of RM, FP & PM)
- Timely preparation & updation of approved vendor list in co-ordination with supply chain and circulate to the concerned departments including the site of Manufacturing.
- To assign unique product code for all the new products/ Reformulated products and circulate it to all the concerned departments including the site of manufacturing.
- Ensure Item code of Raw materials and Packing Materials is provided and intimated to all the site of manufacturing.
- To ensure data and document control of all the documents issued from corporate office.
- To have cordial relation with superiors, peers and subordinates.
- Work in close co-ordination with other departments such as Site QA & QC, SCM and PPC to ensure timely completion of jobs.
- To carry out any other functions given by the superiors from time to time.

AUDIT : USFDA, WHO, MHRA & Other Vendor Audits Faced.

HOBBIES : Playing Cricket, Swimming, Reading books,News paper
Current salary : -- 2, 60,000 /annum

[Guest]

CURRICULAM –VITAE
VITIN CHAUHAN
E-mail- vitinkumar AT gmail.com
Chauhan.vitin AT yahoo.com
CAREER OBJECTIVE : -
- To Work like a professional by working as a team and contributing significantly for the growth of an organization.
CURRENT COMPANY EXPERIENCES : -
- Presently Working in TORRENT PHARMACEUTICALS SIKKIM as an Administrative Assistant in Production Planning & Control (PPC) Department in Sikkim from 09th October 2010 to till Date.
RESPONSIBILITIES :-
- To Monitor Code to Code of Various Raw material & Packing Material.
- To make Stock transfer Requisition (STR) & Stock transfer order (STO) for Material to send/received from Indrad, Torrent Research Center (TRC) & LLM.
- To make Packing Plan (Packing Loading) according to Packing Machine for considering the Priority of Product, COR6 date of SFG & expected delivery date of Packing Material.
- To make Packing Process order as per weekly Packing Plan through SAP.
- To check the recipe version & material availability before making PO.
- To update the daily production report (DPR) of packing for the current month.
- To Co-ordinate with Purchase, Store, Production, QC, QA & TRC for carrying out the Packing Process smoothly.
- Follow-up for various document related to code to code & Change Control Form (CCF).
- To receive the availability date of the planned material (PM) from purchase for Packing of the SFG.
- Follow-up for timely release of SFG for packing with QC & timely release of FG for Bond storage room (BSR) transfer.
PREVIOUS COMPANY EXPERIENCE :-
- One Year Experience in AKUMS DRUGS & PHARMACEUTICALS LIMITED as an Officer in Production Planning & Inventory Control (PPIC) Department in Haridwar.
RESPONSIBILITIES :-
- RM & PM Planning & Indenting according to the order received from Head Office (HO) Delhi.
- New Product Development & follow-up with HO regarding the New Product artwork (A/W), Product Information Sheet (PIS).
- RM & PM follow-up with vendor & HO, Co-ordinate & follow-up with in-house department also.
- Co-ordinate & Communication with customer providing them all information regarding their Product, & resolving all issues of the customer.
- To make Raw material Process order received in Plant through ERP.
- Control of Product MRP& maintain the record in ERP & MRP Product file.
- To make MRP Product Format & initiate to required department like QA & Production.
- To make Beta Batch calculation & modify the BOM in ERP according to the calculation.
- To Plan the Shipper (CB) & Control the inventory of Packing Material.
STRENGTHS :-
- Positive attitude, Producing result, Creative & Hardworking, & Believe in achieving things.
PROFESSIONAL QUALIFICATION :-
- MBA Degree Passed with the Specilization of Marketing (Major) & HR (Minor) from SAMS INSTITUTE OF BUSINESS MANAGEMENT in Varanasi (2007 -2009) with 69.76%.
- One year diploma in leather goods technology (specialization in sports goods) from process cum product development center (PPDC) in Meerut with 87.76%. An autonomous organization under SIDO Ministry of Micro, Small & Medium Enterprises, Govt. of India.
ACADMIC QUALIFICATION :-
- B.Sc (PCM) Passed with second Division in 2007 from CCS University Meerut.
- 12th Passed with second Division in 2004 from DAV Public School, Muzaffarnagar (C.B.S.E Board)
- 10th Passed with second Division in 2002 from DAV Public School, Khatauli (C.B.S.E Board)
.
SOFTWARE AWARENESS :-
- SAP, ERP & GANGA
COMPUTER AWARENESS :-
- Windows 2000, 2003, 2007, Xp, MS DOS
Software, MS Office (Excel, Power Point, Word), Internet.
COMMUNICATION SKILS :-
- English - Can speak, read & write
- Hindi - Can speak, read & write
HOBBIES :-
- Interactive New People, Travelling & Reading Books.

[Guest]

Objective :
To work with an organization where i will get an opportunity of growth and development in the field of quality assurance.

Key Strengths :
I am a self-esteemed and amicable person with positive approach. As a leader, I believe and practice with effective succession plan, to be flexible for taking up new challenges, and grow on fast track as well, in the career.

Educational Qualification :
Master of Science in chemistry, Nagarjuna University, Andhrapradesh.
Bachelor of Science in chemistry, Andhra University, Andhrapradesh.

Experience Profile :
Total Experience 7.0 Years 2.0 Months
Current Position :
(From June - 2010 to till date) Validation Officer- QA
RIYADH PHARMA
Kingdom of Saudi Arabia, Riyadh.
Description of the Organization : RIYADH PHARMA is a renowned Riyadh based company, involved in manufacture of various pharmaceutical dosage forms, Tablets, capsules, Liquid (Syrup, Suspension, Drops) and sterile (Cream, Ointment, Eye, Ear and Nasal drops ) drug products.
This facility has cGMP certifications from various regulatory agencies, i.e. IMB,GCC, SFDA etc.
Responsibilities - Coordinating in the Preparations of the Validation Protocols, Monitoring various Stages of Process Validation Exercises being carried out at Shop-Floor, Identification of Critical Process Parameters, Documentation of various observed parameters, Validation Sampling & Assurance, Preparation, compilation & Review of Final Reports.
- Preparation of Cleaning Validation Protocol, Worst case Matrix, Execution, sampling, compilation of data and preparation of Final Reports.
- Preparation of Hold Time study protocols, execution, sampling, data compilation and final reports preparation.
- Qualification Protocol Preparation and Execution of Quality Control Laboratory Instruments.
- Quality Control Analytical data review.
- Review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Review of all user departments Sop’s.
- Handling of Change control, CAPA and Deviations.
- Preparation of Annual product review (APR).
- Conduct Training of Management Staff on cGMP and other operational attributes.

From August - 2006 to June - 2010. :
QC Process validation Sr.Executive
Aurobindo Pharma Ltd,Unit –III,
Hyderabad, A.P, INDIA.
Description of the Organization :
Aurobindo Pharma Limited is a reputed company for manufacturing Tablets, Capsules & Oral Liquids.
This facility has CGMP certifications from various regulatory agencies, i.e. USFDA, MHRA, WHO, MCC and ANVISA etc.
Responsibilities :
- Analysis of In-process samples.
- Analysis of Finished Product samples (Tablets, Capsules, and Oral Liquids).
- Process validation samples analysis at different stages.
- Submission batches, Bio-batches analysis as per protocol and In-House specifications.
- Perform the Multimedia Dissolution Profiles Different Products and compare to F1, F2 Values.
- Cleaning Method validation and cleaning validation samples analysis.
- Analysis of Hold Time samples.
- Analysis of Water samples (Purified Water & Raw water).
- Performance Qualification (PQ) Samples analysis.
- Raw material Samples Instrumental Analysis.
- Calibration of Instruments and maintaining of records.
- Analytical review of Exhibit and Bio Batches, Hold Time, Validations, in process and Product Development samples.
- Instrumental interfacing with caliber LIMS software (2.0 & 3.1 ver.) for registrations, work Sheets taking, online entries and reviews.
- Co-ordinate during the audits USFDA,UK-MHRA,WHO,MCC-SA,ANVISA-BRAZIL and Other Customer Regulatory Audits.

From March - 2004 to August - 2006 QC Chemist :
Gland Pharma Ltd
Hyderabad,A.P, India.
Description of the Organization :
Gland Pharma is involved in the development and manufacture of wide range of pharmaceutical products.
This facility has CGMP certifications from various regulatory agencies, i.e. ISO 9001, WHO-cGMP and USFDA, etc.
Responsibilities :
- Packing material analysis (primary & secondary packing materials).
- Finished Product analysis.
- Raw Materials analysis

Instrumentation Knowledge :
- HPLC-Agilent-1100, 1120 Series, Waters Alliance-2695, 2696(PDA), 2487 (Binary & Quaternary) with Empower-1 and 2 Software and Shimadzu with Class VP.
- Dissolution- Pharma Test, Lab India, Electro lab.
- U.V – Shimadzu.
- Infrared spectrophotometer –PerkinElmer.

Calibrations :
- High performance Liquid chromatography (HPLC).
- Ultraviolet–visible spectrophotometer (UV spectrophotometer).
- Infrared spectrophotometer (IR spectrophotometer).
- Daily Calibrations (Like pH Meter, Balance…).

[Guest]

Dear Sir,
I have already applied on Glenmark Official website. Still here I am posting my CV for better visibility of the employer.
Amit K
E-mail ID : abkhodke AT gmail.com

CAREER OBJECTIVE
To pursue a challenging career in a progressive organization that gives scope to enhance my knowledge, skills & to reach the pinnacle in Pharmaceutical field with sheer determination, dedication & hard work.
To work with the people having excellent technical background, good management skills & leadership qualities so as to become a good leader in this field.
CURRENT STATUS :
Presently working as an “Officer - PDL / Tech Transfer Dept.” at Mylan Laboratories Ltd., Nashik.
Total Industrial Experience : 5 yrs.
CAREER WALKTHROUGH
1] Current Employer : Mylan (Matrix) Laboratories Ltd.
Present Position : Officer (PDL)
Tenure : May 2010 to Present

Job Profile :
- Dealing with process development activities for solid dosage forms in co-ordination with
R & D and RA dept. for several markets.
- Preparation of process validaiton report from Technical Data received from the QA, QC,
R&D and Production department.
- Documentation of all activities coming under Process R & D for various international markets – USA, WHO, REXP, SA, PEPFAR, Australia, Canada, India.
- BMR Preparation and their review for Scale-up, Exhibit and Intended-commercial batches.
- Process validation protocols, exhibit batch protocols and reports preparation and review.
- Preparation of Process evaluation plan, Batch sampling plan.
- Exposure to SAP (Production Planning and Material Management) related activities for recipe preparation, new material code generation, ZCR Group download and tracking of all the BMR’s marketwise, material code wise, process wise.
- Working with Global Trackwise document management system for change control - Change control initiation and evaluation with respect to product and market. Its prior approval and tracking till closure.
2] GlaxoSmithKline Asia (Biologicals) Private Limited :
Position : Production Chemist / Officer

Tenure : May 2007 to May 2010.

Job Profile :
- Pooling & Filling of vaccines (Hepatitis A / Hepatitis B) in the grade B environment.
- Maintaining the frequency of cleaning & fumigation of classified area after operation.
- As a production staff, responsible for daily Environmental Monitoring in the classified area. Its documentation, trending & reporting.
- Preparation of SOP, BMR, BPR, process validation protocols & their revision as per the process change.
- Ordering & follow-up of the required equipment or material in the Dept.
- As a packaging staff, responsible for the Batch Labeling & Packaging of Semi finished Vaccine vials, maintaining the cold chain, BPR completion & review – More than 7 different vaccines portfolio for Labeling & Packaging.
- Learning & implementation of “5 S” and “lean culture deployement” systems at work place.
- Usage of system improvement tools like CAPA, fish bone analysis, factory visual aids (visual factory concept), and flow chart display at work place – GSK Global Excellence award under continuous improvement programme.
- As a QA Validation staff, validations performed in the production Dept. before commercial vaccine filling :
1. Environmental monitoring and area qualification of grade A, B, C, D.
2. Water qualification (IQ, OQ, PQ)
3. Cleaning & disinfectant validation
4. Equipment qualification (IQ, OQ, PQ) perfomed : Autoclave, sterilizing tunnel, HVAC, clean room, LAF system, blister pack machine, labeling machine and compounding vessel.
5. Computer related system (CRS) validation – CRS backup as per WHO guidelines
- Media fill, non-commercial consistency filling Hepatitis A / Hepatitis B vaccine with all good aseptic practices followed.
- Preparation of Master Validation Plan (VMP), Continuous Validation Plan (CVP)
- System level impact analysis (SLIA), Component level impact analysis (CLIA) during installation of new equipment or system.
3] Noble Drugs Limited :
Position Held : QA Officer

Tenure : December 2006 to May 2007.

Job Profile :
- As a QA officer responsible for In-process QA checks during manufacturing of Tablets, Capsules & Syrup.
- Worked in Entrepreneur Resource Planning (ERP) system.
- Coordinating with plant manager for regulatory audits preparation and documentary frame work required for liscence and approval.
- SOP’S preparation, review & documentation.
4] FDC Pharmaceuticals Limited :
Position Held : Marketing Representative

Tenure : June 2006 to September 2006.

Job Profile :
- To represent the company’s products to the direct customer- Doctors, Retailers, approved dealers in the Nashik Headquarter.
- Weakly updates of the stock statement from the dealers, wholesalers.
- To meet the monthly target of sales & promotion.
EDUCATION
B. Pharmacy from MGV’s Pharmacy College (University of Pune), Panchvati, Nashik, Maharashtra. (2002-2006)

ADDITIONAL PROFESSIONAL COURSES
- Completed Diploma Course in Computer Application (MS Office)
- Maharashtra State Certificate in Information & Technology (MS-CIT) course passed in 2007
- Advanced Diploma in Process Monitoring from Filtration School Millipore, Bangalore in 2009.
- World Intellectual Property Organization (WIPO), Geneva – General Course on Intellectual Property DL-101.
SIGNIFICANT AVCHIEVEMENTS

- Stood first in situational detailing of the pharmaceutical product in pharma marketing.
- Qualified for gowning in an aseptic area for filling of vaccines.
- Recognized by senior management of GSK Biologicals in the quiz held on Best Quality Statement on vaccine Manufacturing during Quality Weak celebration.
- GSK Global Excellence award under continuous improvement programme.

Hobby : Nurturing my hobby of Singing by active participation in several singing competitions and youth festivals with sincere practice and dedication.
KEY STRENGTHS
Innovative & self directed individual with good communication & interpersonal skills. Able to develop rapport with the people from various backgrounds, cultures & professional levels. Highly adaptive & quick to learn, able to cope with analyzing situations & take initiatives to solve problems. An individual with good moral & committed dedication towards work.

[Guest]

Prashant Devle.
Objective
- To obtain a challenging position in a renowned organization where I can maximize my Quality Assurance experience.
- To work in a result oriented environment and contribute in achieving the corporate goals of the organization.
Profile
- 8+ years experience in Quality Assurance.
- Proven track record in completing assignments on time, maintaining high quality standards & ensuring the highest level of safety.
- Solving problems and taking decisions using local & international quality standards.
- End user in SAP (QM Module), EQMS system.
Skills
- Have thorough knowledge and understanding of cGMP and QMS, Handling Deviations, Change Control, OOS etc., Tracking of CAPA implementation activities, DKMA, EDQM, USFDA experience.
- Quick to solve problems, grasp new ideas and concepts.
- Self Motivated, experienced in working under high level of pressure.
- Adaptable and logical, able to work well and take initiatives.
- Excellent interpersonal skills, able to communicate concisely at all levels.
Employment History
Organization : ZYDUS NYCOMED Healthcare Pvt Ltd, Navi Mumbai
Designation : Quality Assurance – Senior Officer
Duration : September 2009 till Date
Profile :
- To review master Batch Manufacturing Records (BMR), Equipment Cleaning Records (ECR), Specifications and Analytical Work record (AWR).
- To prepare and review Standard Operating Procedures (SOP), Site Master File (SMF) & Validation Master Plan (VMP).
- Reviewing Change controls, Deviations, Investigations, OOS and Complaints.
- Follow-up of Corrective Action & Preventive Action (CAPA) effectiveness.
- Prepared Annual Product Reviews (APR) and submit to HOD QA.
- Conducting internal quality audits as an ‘Internal Auditor’.
- To prepare protocol & report for Process, Cleaning validation.
- Management and control of the Artworks, labels of Export product consignments.
- Maintaining records of all approved artworks & printer proofs.
- Coordinating day to day activities of preparing, issuing, reviewing, maintaining
- Preparing monthly reports for Head of QA.
- Managing the Finished Good Export consignment dispatch.
- License Activities related to Test, Manufacturing licenses, layouts to the FDA, other Government Authorities.
Organization : WATSON PHARMA PVT. LTD, AMBERNATH
Designation : Quality Assurance – Senior Officer
Duration : Nov. 2006 to Sept. 2009
Job Profile :
- Prepared Standard Operating Procedures (SOP), reports for Process, Cleaning validation.
- Prepared Annual Product Reviews (APR) and submit to HOD QA.
- Reviewed Change control / Deviation / Investigation/ OOS /Complaints and archiving of various Quality documents and maintaining the QA records.
- Follow-up of Corrective Action & Preventive Action (CAPA) effectiveness.
- Prepared the Design & Artwork for labels of Export and import product consignments.
- To prepare the documents as per cGMP.
- Supervised the Export and import product consignment before dispatch.
- Participated in license Activities related to Test, Manufacturing licenses, layouts to the FDA, other Government Authorities.
- End user of SAP (Quality Module).
Organization : HINDUSTAN LEVER LTD (FOOD DIV.)
Designation : Quality Assurance – Junior Officer
Duration : August 2004 to Nov. 2006
Job Profile :
- Carried out Sensory evaluation of products as a ‘Sensory panel member’.
- Independently handled packaging material.
- Carried out external packaging sample evaluation for developing new Packaging suppliers.
- Responsible for management, maintenance & control of all approved artworks & printer proofs.
- Participated in packaging of new product / modified product trials.
- Machine trials (Ceka, Holler, Hassia) for packaging of new product / modified product.
- Evaluated vendors & recommended vendors to the organization
- Performed competitor’s product evaluation.
- Carrie out appropriate experimentation & documentation related to the trails.
- Monitored online finished good check / analysis & QDI.
- Handled market complaints & investigation.
- Conducted internal & third party quality audits & participated as ‘Auditor.
- Performed trend analysis of finished goods data on critical parameter.
Organization : NOCIL (RUBBER CHEMICAL DIV.)
Designation : Trainee Chemist
Duration : Jan. 2004 to August 2004
Job Profile :
- Carried out Analysis of raw materials, packaging materials and finished products.
Equipments Handled
- Bursting Strength tester, Rub Resistance Tester.
- Cobb’s tester, Refractometer (R.I.).
- Moisture Analyzer, Bostwickmeter
Achievements
- Successful QA team member in achieving better grades in Unilever audits.
- Member of successful QA team which achieved in TPM Level 1.
- ‘Certificate of Achievement’ for EDQM & USFDA Audit.
- ‘Certificate of Achievement’ for ‘Project Gallop’.
- Awarded for ‘Best Performance in Quality Assurance Dept.’ for achieving Highest Export production target.
- Successful QA team member in DKMA audits for new products transfer.
Qualifications
- Appearing Post Graduation Diploma in BUSINESS ADMINISTRATION
Prin. L. N. Welingkar institute of Management Development & Research, Matunga.
- Appearing Post Graduation In CHEMISTRY
Madurai Kamraj University, Madurai.
- Graduation In Chemistry (March 2003)
Mumbai University. Mumbai.
- Post Graduation Diploma In PACKAGING
Indian Institute of Packaging, Andheri. Mumbai
- Post Graduation Diploma In TOTAL QUALITY MANAGEMENT
All India Institute of Management Study, Chennai
- Post Graduation Diploma In APPLIED ANALYTICAL CHEMISTRY
Advance Study Center Thane

[Guest]

Respected Sir / Madam,
I have completed my B. Pharm and having 2 year of exp. in Quality Assurance Department.
I m working with Corporate Pharma as a QA Executive. Please consider me if there is any opening in QA department.
Deepika R. Sharma
Email :Deepuias AT yahoo.com;
Specialisation : B. Pharmacy
Work Experience :
- Since May’11 – December’11 with “STERLING PHARMA LIMITED” Talegao, Pune as Trainee QA.
Key Responsibilities :
- BMR issuence and Document retrieval,
- Preparation of BMR/BPR and Review,
- Maintained Record of Control Sample Room
- Storage of Finished Good Retain Samples with location.
- December - 2011 to May – 2012 with “HINDUSTAN LABORATORIES” Palghar, Mumbai as a QA Officer.
Key Responsibilities :
Worked as an IPQA Chemist, PM and RM Requisition checking.
- Line Clearance & In-Process Quality Assurance.
- Filling of Change Control and Deviation form.
- Handling Market Complain and filling Corrective and Preventive Action.

Highlights :
- SOP Preparation, Conducting Validation Batch and Filling Validation Protocol, Familiar with Validation and Qualification Documents.
- Operating and doing Calibration of following Instruments.
(a) Weighing Balance
(b) Leak Test Apparatus
(c) Friability Apparatus
(d) Disintegration Test Apparatus
(e) Hardness Tester
(f) and PH Meter.
- I have been faced WHO, Party Audit and ISO audit.
- Currently working with SRS Pharmaceuticals Pvt. Ltd. As a Quality Assurance
Executive.
- Preparation of SOP’s as per ISO format.
- Artwork checking and approval.
- Quarterly Manufacturing site audit and filling the format of Vendor Questionnary.
- Preparation of Master Formula Record and Batch Manufacturing Record.
- Preparation of finished product specification and Raw material specification using Pharmacopeias.
- Handling Market complaints and rectifying it. Taking Corrective and preventive action against and maintaining record of all complaints.
- Preparation of Monthly Product Review and Annual Product Quality Review.
Training & Project

Industrial Training :
Duration : 1 month
Company : “GUFFIC BIOSCIENCE LIMITED” kabilpore, Navsari, Surat
Brief Description
- The entire Training was regarding about GMP Guidelines for Manufacturing of Drugs.
- This involves a general Induction Training and to understand the activities of Production.
- Awareness regarding Parenteral like maintains Aseptic conditions favorable for parenteral areas.
Mini Project and Seminar :
- Seminar on “Tray Dryer” and “Fluidized Bed Dryer”
- Project on “Role of QSAR in Novel Drug Design” i.e. Quantitative Structure Activity
Relationship.
“QSAR is essentially a computerized statistical method which tries to explain the observed variance in the biological effect of certain classes of compounds as a function of molecular changes caused by the substituents.”
Educational Qualifications :
- Completed B.Pharm from North Maharashtra University with 77.57% Maharashtra in 2011.
- Completed HSC from Divine Child High School with 64% Gujarat State Board in 2007.
- Completed SSC from Krishna School, Surat, With 82.85% Gujarat State Board in 2005.

Extra-Curricular Achievements :
- I won the certificate on Hindi Essay Writing competition at district level.
- Second prize in English Hand Writing Competition at district level.
- I have attained the seminar of Personality Development at Gov. College of Sahada Village.
Professional Skills :
- Knowledge of MS Office, Windows XP, Internet Browsing.
- Good analytical, presentation and communication skills.
- Positive attitude, never give up things easily.
- Easily adjusted to the changing conditions

Personal Details :
- Name : Miss Deepika R.Sharma
- D.O.B : 29th may 1989
- Language Proficiency : English, Hindi, Gujarati, & Marathi
- Hobbies : Reading Magazine on Current Affairs, Group Discussion.
Place : Mumbai
Date : 12 January 2013 (Deepika Sharma)

[Unregistered]

CURRICULUM VITAE
RITESH AGARWAL
Roorkee (Uttarakhand)

Career Objective :
- To grow with professionally managed organization requiring planning, coordinating, problem solving and analytical skill and play a key role in the advancement of new height.
- A strong motivation skill along with strong desire to work in the organization that matches my profile by constant learning and implementing. Looking forward for challenging career in the "Parenterals” industry to prove myself with continuous hard work in the provided area of development.

PROFESSIONAL PROFILE :
- Comprehensive problem solving abilities, communication skills, confident, creativity and ability to deal with people diplomatically, willingness to learn, and team facilitator.

Educational Qualification :
- M.Sc. in Commercial methods of Chemical Analysis from Gurukul kangari University
Technical Qualification :
- Approved as a Competent Technical Staff by Drug Regulatory Authority, Dehradun (U.K.) in Chemical Analysis & instrumental analysis.
Work Experience PRESENTELY WORKING IN SIEMEN LABORATORIES INDIA (P) LTD.

COMPANY PROFILE :
Siemen laboratories india (P) ltd. has a manufacturing unit at Haridwar boasts of world class technology and a strong team of professionals. The manufacturing expertise is available for almost all dosage forms viz. Capsules, Tablets, Liquid orals, Dry Syrups and injectables in both beta-lactum and non beta lactum category.
M/S SIEMEN LABORATORIES INDIA (P) LTD. :
Designation : Asst. Manager QA
Division : Capsule ,Tablet , Liquid orals , Dry syrup , Injectables
(Both beta lactum and non beta lactum )
Work Period : FROM JUNE. 2012-TO PRESENT

PIONEER COMPANY FOR PHARMA INDUSTRIES SULAMINAYAH KURDISTHAN :
COMPANY PROFILE :
One of the largest and most technologically advanced manufacturing companies of life saving drugs in Kurdistan sulaminayah. The company is engaged in manufacturing high quality generic drug products including tablets, capsules, syrup, dry suspension, and intravenous solutions, in compliance with the local and international cGMP regulations.

M/S PIONEER COMPANY FOR PHARMA INDUSTRIES SULAMINAYAH KURDISTAN :
Designation : Sr. QA Executive
Division : Large Volume Parenterals & Oral Liquid.
Rommelag m/c (B.F.S Technology of Polyethylene Bottles)
Work Period : SCINCE NOV. 2010-TO MAY 2012

AXA PARENTERALS LTD :
COMPANY PROFILE :
AXA Parenterals Ltd has first of its kind I.V. Fluid plant in Roorkee, Uttarakhand, the hilly state of India. AXA's Intravenous Fluids are manufactured in High Quality Plastic LDPE granules under aseptic conditions using the latest “State-Of-The-Art” FFS Technology.

M/S AXA PARENTERALS LTD. Roorkee :
Designation : QA Officer
Division : Small Volume Parenterals And Large Volume
Parenterals.
Rommelag m/c (F.F.S Technology of Polyethylene Bottles )
Work Period : SINCE JAN. 2006-TO OCT. 2010
COMPANY PROFILE :
Amideep Pharmaceuticals is engaged in production and marketing of Skin ointments, dental products, oral liquids since last 28 years in roorkee uttrakhand

M/S AMIDEEP PHARMACEUTICAL Roorkee :
Designation : QA Chemist
Division : oral liquid , skin ointments
Work Period : SINCE JAN. 2005-TO DEC. 2005

ACHIEVEMENTS : Face license audit from MOH Kurdistan and GMP inspection,
Job Profile : Documentation Specialist:
Preparation and modification of documents as per regulatory requirement like site master file , safety manual , BMR, BPR, MFR, SOPs. Protocol , log book , formats , training records ,
- Documents issue and control
- Allocation BMR (Batch Manufacturing Record) & BPR (Batch Packing Record).
- Line clearance at all critical stages.
- QA Inspection of entire manufacturing and quality control unit.
- Responsible for new comer IPQA and training programme for new IPQA Person.
- Documentation of all QA activities, Review of documents,
Counter checking of all documents filed by subordinates for their activities. Implementation of cGMP.
Validation :
- Responsible for preparation of documents related to Cleaning Validation, Process Validation , HVAC Validation, Media fill validation , autoclave validation , visual inspection validation , area validation and also performs all validation activities
Calibration :
- Preparation of yearly calibration plan for all over the company system and perform the calibration according to plan and making calibration report.
Change control :
- Preparation the documents for change control
- Arrange the training program for change control
- Applied the change control for the system and close the change control
GMP Deviation :
- Preparation the documents for Deviation
- Arrange the training program for Deviation
- Applied the Deviation for the system and close the Deviation
Market compliant :
- Preparation the documents market complaint
- Arrange the training program for market complaint
- Login, Handling the market complaint and close the market complaint as soon as possible according to system.
Responsible for :
- IPQA activities during production and packing and implementation the system according to cGMP.
- Control sample management and periodic inspection
- BMR , BPR compilation , Checking and batch release and arrangement of released BMR, BPR
- Regular Internal audits and making the report and implementation the system according to cGMP
- Handling of rejected / recalled materials
- Monitoring and approval of reprocessing, reworking and repacking monitoring
- In-Process Quality Assurance checks during manufacturing (upstream and downstream) and packing activities.
- Maximum utilization of the available resources, on job training to workmen & staff based on SOP- s and evaluation through feedback.
- Communication with the interrelated departments.
- Reporting :Daily activities related to plant to the seniors
- Supervision of Shop Floor and maintain as cGMP.
- Arrange tanning program for juniors ,and fresher’s

Project Work :
Project work in M.sc :
- One month project Determination of trace metal in various water sample by atomic absorption spectroscopy from national institute of hydrology IIT Roorkee Uttaranchal
Project work in Axa Parenterals limited :
- Project work in Axa Parenterals in validation of MF Sterilizer, Laminar air flow & HVAC System.
Project work in Pioneer company for pharma industries
- Project work in Pioneer Company for Pharma Industries in validation of MF sterilizer, laminar air flow, & HVAC system and area validation.
Languages Known Hindi & English.

Personal Details :
Name : RiteshAgarwal
Date of Birth : 04-Dec-1980
Father’s Name : Shri. Vinay Kumar Agarwal
Nationality : Indian
Marital Status : Single
Hobbies Reading, Travelling & Listening Music.

Date :
Place : (Ritesh Agarwal)

[Unregistered]

MR. S.S. NIRMAL
Mail ID :nirmal.santosh AT rediffmail.com

M.Sc. with about 16 years exp. in Quality Assurance & Quality Control DEPT in Multinational Pharmaceutical Company having Schedule-M (GMP),WHO GENEVA,USFDA MHRA, MCA,MCC Approved In Tablet ,Powder, Capsule, Syrup Plant.

EDUCATIONAL PROFILE :
M.Sc. (Total Quality Management), from Delhi. Uni.
B.Sc. (Chemistry) from Mumbai Uni.

FDA APPROVALS :
1. Maharashtra FDA approval in Chemical & Instrumentation Analysis.
2. Maharashtra FDA approval in Microbiological Analysis.

JOB PROFILE :
1. Emcure Pharmaceutical Ltd. Pune at CORPORATE GMP-QA Dept .
Since 2011 To 2013 till date as Quality Assurance Executive.

2. Emcure Pharmaceutical Ltd. Pune at PLANT (The Fast growing pharmaceutical company)
(USFDA/MHRA/MCC/MCA/ANVISA/WHO/Schedule-M Approved Plant.)
Since 2005 To 2010 as Quality Assurance Executive

3.UNI SANKYO LIMITED, Lote Parshuram, Ratnagiri
(A Sankyo Co., Japan group of company). (MHRA/MCC/MCA/WHO/Schedule-M Approved Plant.)
Approved Plant, India's largest & Pioneer manufacturers of Lactic Acid Bacillus
(Lactobacillus sporogenes - Submerged fermentation)

Since 1995-2005 as Quality Assurance Executive.
# Total Period of Service : June 1995 till date
Currently Faced Audits : UKRAIN (ACTAVISA) ,ZIMBABE,IVORY COAST, UGANDA, KENYA, KAZAKISTAN, NAMIBIA, TANZANIA ,GLAXOSMITHCLINE, NOVARTIS ,NACO, WHO-GENEVA, USFDA,ANVISA.MCC,MCA & MHRA.

EXPERIENCE OF SOFTWARE HANDLES : PHARMA AND SAP SYSTEM (QA & QC)
PRESENT JOB RESPONSIBILITIES at CORPORATE QA Dept.– Since 2011 to till date 2013) :
1.Co-ordination bet transferring site and receiving site of all technology transfer of ANDA Products .
2.To check and approve artworks of all dosages forms such as Tabs, Caps, liquids, Injections. Ointments, Foods & give technical inputs referring all types of guidelines.
3.To handle corporate Change control /Deviations/Market complaints .
4.To review all types of the regulatory related work and co-ordinate with seniors.
5.To launching of New Product on P to P basis, Review third Party vendors samples along with all types of Quality documents through QA & regulatory point of view for evaluation and approval of New Product coordinating with third Party QA and Emcure outsourcing QC Dept .
6.To control and approve all corporate QA activity through SAP system of various modules.
7.To Conduct audit of Emcure sites through regulatory and GMP/QA point of view.
8.Review & approved Blank/filled BMR/BPR/VR of various sites of Emcure /Zuventus

# PRESENT JOB RESPONSIBILITIES (QA Dept. – 9 Yrs. Since 2000 to till date 2010) :
1. Documents preparation & distribution such as VMP, VP,VR, MFR, BMR, BPR, SITE MASTR FILE SOP, RM/PM/ INTERMEDIATE/BULK/ FINISH PRODUCTS SPECIFICATION.
2. To handle Deviation Reports-(Anticipated/Unanticipated) .
3. To handle Change Control (Minor/Major)
4. To handle Market complaints (Technical/Medical/Commercial)
5. To handle Non Conformance reports (Major/Minor)
6. Equipment Qualification- (URS/DQ/IQ/OQ/PQ)
7. Validation - Process, Concurrent, Retroscopic Revalidation. Cleaning validation, (Chemical & Micro.related.), AHU validation.
8. All departments Inter departmental audits [LEVEL I & LEVEL II] (PRODN,QC,QA, STORE ,BULK DRUG , MAINTENANCE,HR)
9. To handle the discrepancy and CAPA action .
10.All In process quality related work such as stage wise line-clearance, on-line BMR/BPR checking.
11.To monitor the Laboratory investigations (OOS/OOE) for all quality related issue.
12.Product-to-Product changeover Rinse/Swab sample analysis.
13.Monitor & Control Reprocess/Rejection/Reworking/Recovery./Recall.
14.Monitor Product holding time/ R.O life stage wise.
15. Periodical Product Review or Annual Product Review.(Trend analysis)
16.Stability Study–Monitor stability analysis on line products as per ICH GUIDELINES.
17.Monitor Periodic Control Sample Analysis.(RM & Finish product)
18. To do all regulatory work such as prepare Products licenses & FDA related any works.
Additional products licenses application, License Surrender, Application to COPP [WHO (GMP)] certificates , Free Sale Certificate to various countries, No Conviction Certificates, Manufacturing & Marketing Capacity Certificate , Work on Revised GMP & WHO certificate, FDA intimation to any regulatory Related Work.
19. Art works Checks and Approved as per Domestic and Export Products requirement of various countries.
20.Conduct training (GMP & SOP related) workers & supervisory level.

# Job Responsibilities (QC Dept. – 4 Yrs. Since 1996-2000) :
1. Sample & analysis of RM/PM as per pharmacopoeia guidelines and IH method.
2. Bulk blend, Semi finish, finish product sample and analysis as per pharmacopoeia guidelines.
3. Prepare and standardize Volumetric standard solutions.
4. Manage and prepare Reference and Working standard as per SOP.
5.Calibration of Volumetric Glass ware.
6. Operate and calibrate the Instruments.
7. Any Microbiological work as per SOP such as TVAC,TFC,MLT,SWAB ANALYSIS.PLATE EXPOSURE,(SETTLE PLATE,CONTACT PLATE METHOD), AIR SAMPLING BY SLIT METHOD [CHEMICAL AND MICRO] ,DM WATER ANALYSIS, AREA VALIDATION.
8. Review final RM/PM/FINISH REPORT before release any material or dispatch to any party.
Equipments Handled (LAB) :
HPLC,GC,FTIR, Spectrophotometer, Polarimeter, Dissolution test Appa., Karl Fisher Appa., PH meter, Conductivity meter, IR Moisture balance, Friability Test Appa., Oven, Stability chamber, Incubator, Laminar Air Flow Bench, DT apparatus.

# Job Responsibilities (Production Dept. AS PRODUCTION CHEMIST) – Since 1995-1996)
1. Assigning work to Shift Officers and Supervision of all plant activities.
2. Documentation as per CGMP norms.
3. Planning and conducting the process development experiments at Lab as well as at plant level.
4. Working as GMP coordinator for formulation department.
5. Training of subordinates related to process & GMP.
6. Yield improvement in formulation.
7. Yield Improvement & Product quality improvement in Pharma Plant.
8. Cost saving by adopting new ideas.
9. Validations and Calibration of Equipments.
10. Conducting interdepartmental audits.
Equipments Handled (Production) :
Sifter, FBD, Planetory Mixer, RMG, Mass Mixer, Multimill, Clit Mill, Cone Blender, Octagonal Blender, Jackted Vessels, Spray dryers, Vacuum dryer, Tray dryer, Autoclave, Compression machine, strip pack machine, Blister pack machine, Sachet filling machine, Tablet defoiling machine, Dispensing Booth .

PERSONAL PROFILE :
Name : Mr. Santosh Shankar Nirmal
Father's Name : Mr. S.B.Nirmal
Date Of Birth : 09.03.1973
Marital Status : Married
Languages Known : English, Hindi & Marathi
PRESENT SALARY : Around 5.0 LAC PA.
EXPECTED SALARY : Around 7.0 LAC PA (Negotiable as per requirement)
(Mr. S. S. Nirmal)