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Quality Assurance Manager

Location:
Pune, MH, India
Posted:
March 04, 2014

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Resume:

‘Matoshri’ Orient Park, Gate No.*

Plot No.**, Sade Satra Nali Road,

Malwadi, Hadapsar

Pune-28

MobileNo.985*******

Email: accya7@r.postjobfree.com

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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