Quality Assurance Manager
Resume:
‘Matoshri’ Orient Park, Gate No.*
Plot No.**, Sade Satra Nali Road,
Malwadi, Hadapsar
Pune-28
MobileNo.985*******
Email: ***************@**********.***
MR. RAHUL POPHALIKAR
Objective I wish to be a part of an organization, which hones my abilities and enhances my skill set to serve
the best interest of both the organization & myself.
Summary of 2000-2002 BHARATI VIDYAPEETH POONA COLLEGE OF PHARMACY, PUNE.
Qualifications MASTERS IN PHARMACEUTICAL CHEMISTRY.
Passed with First Class (60 %)
THESIS :-Synthesis and biological evaluation of Glucosamine Conjugates of NSAID-A Prodrug
approach
1994 – 1999 D.S.T.S Mandal’s College of Pharmacy, Solapur.
BACHELOR IN PHARMACY.
Passed with First class (60%).
May 2013 to Dec 2013 Shalina Laboratories,Jejuri, Pune
Professional
Sr. Executive Quality Assurance
Experience
• QA systems
• Review of Annual product review
• Self Inspection
Jan 2011 to May 2013 Sai Life Sciences,Pune
Asst.Manager Quality Assurance R&D
Working in QA Dept looking after
• QA systems
• Review of Specifications and STP
• Review of Analytical Method Validation and Method Transfer Protocols and reports.
• Timely submission of all required documents to transferring site and clients.
• Preparation & Submission of weekly & Monthly reports.
• Support to Formulation Development & Analytical Development Dept.
Dec 2009 to Dec 2010 Glenmark Generics Goa
Executive Quality Assurance-Solid Dosage form
a. As a shift Incharge Responsible for all the shop floor activities and manpower
management.
b. Responsible for Incidents and Deviations for shop floor.
c. Coordinate with production for successful completion of validations.
d. Shop floor Observations.
e. Review of completed batch records and checking Master Batch Records.
f. Release of semifinished batches through SAP system.
g. Approval of Batch Records.
July 2007 to Nov 2009 Wockhardt LTD.,Aurangabad
Senior Officer Quality Assurance-Injectable (Dry Powder- Cephalosporin Division).
a. Preparation of Validation Protocol & summary & co-ordination in Validation activities.
b. Process validation, Media Fill, HVAC (Oral & Injection), Autoclave validation Tunnel
Validation.
c. Handling of Change Controls, deviations.
d. Co-ordination between all Departments For Preparation & Revision Of SOP’s.
e. Issuance & retrieval of documents to all departments(BMR,BPR,Sop’s, Worksheets, Blank
formats)
f. Annual product report review.
g. Submission of Completed Documents To Regulatory Dept. for registration.
h. Maintenance of documents.
i. Monitoring of Production Activities.
j. Vendor qualification.
K.Preparation of QA SOPs.
l. Preparation and submission of Monthly reports.
m.Market complaint communications.
Feb 2004 – to Jun 2007 Cipla, LTD. Kurkumbh, Pune.
Quality Assurance Officer- Solid Dosage form.
a. Handling of ANDA documents
1. Checking of Master batch manufacturing records (ANDA and Commercial).
2. Review of executed BMR.
b. Handling of depot complaints.
c. QA observation rounds on shop floor.
d. Activities of packing department.
e. Dispatch handling.
f. Vendor audits.
g. Self Inspection.
h. Handling of change controls.
i. Checking of Master Manufacturing Formula.
Achievements Published research paper on :
1) Synthesis and pharmacological evaluation of mutual prodrugs of some NSAID’s with
Glucosamine (Ibuprofen and Diclofenac) in Indian Journal of Pharmaceutical sciences.
2) Synthesis, stability studies and pharmacodynamic profile of mutual prodrug of Ketoprofen
with Glucosamine in Indian Drugs.
3) Vascosupplementation of Neutraceuticals: dawn of new era in Osteoarthritis in Indian Journal
of Pharmaceutical Education.
4) Award in Pharmacology section for the above article.
Current salary-5.50 lac.Per Annum
Salary package
Expected salary- 6.75– 7.50 lac.Per Annum
Languages known
Read, Write and Speak – English, Hindi and Marathi
About myself Determined, dedicated and focused approach to challenging situations is my way of working.
Date :
(Rahul Pophalikar)
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