Quality Assurance with 4 year experience

ATUL S MAHAJAN

Contact: 098********/ 097********

E-Mail: *******.******@*****.***

In quest of assignments in the domain of Quality Assurance and Regulatory compliance in

pharmaceutical industry

Professional Synopsis

Qualified M.Pharm (Quality Assurance) Professional with more than 4.0 year of experience in

Quality Assurance, and Documentation.

Currently associated from last 4 month with Getz Pharma Research, Ambernath, and Thane as

Quality Assurance Research Officer.

3 year and 7 month experience with Sun Pharmaceutical Industries Limited, Gujrat as

Quality Assurance Officer II.

6 Month experience with Dr. Reddy’s Laboratories Ltd, Hyderabad as M Pharmacy Project

trainee in QA Dept.

Well Knowledge of ICH guideline & ANDA Regulatory Guideline

Organisational Experience

Key Deliverables

Handling and Review of Product development Protocol and Report.

Handling and Review of Analytical Protocol and Report, Standard Test Procedure, Tentative test

Procedure, Specification.

Handling Change control management from issuing and execution of change and impact analysis,

review all report and quality problems.

Handling and Review of Technology Transfer Document.

Handling Master formula card/master product specification and handling of BMR,BPR issuance,

review, closing and release at different stage of manufacturing

Preparation, review of Standard operating Procedure and conduct training on SOP.

Experience and conducted Audits with coordination of other department.

Handling Vendor Qualification Related Documents.

Prepared and Executed of Annual Product Quality Review

Experience of Preparation exhibit and Process Validation Protocols, Report and executing

Validation Batches.

Experience of handling Market complaint and coordination of complaint.

Experience about Investigation of Event, Incident quality problems and Assigning, monitoring of

CAPA activities.

Experience of Shop floor Activities QA Round, In process Quality monitoring

Scholastics

2010 M.Pharm (Quality Assurance) from School of Pharmacy & Technology Management,,

NMIMS University, Mumbai. (Scored GPA 3.29/4.00)

2008 B.Pharm from Smt. S.S.Patil College of Pharmacy, Chopda, NMU, Jalgaon. (Scored

63.50% marks).

2004 XII from Lalwani College of Arts, Science & Commerce, Jamner, Nasik Board. (Scored

66.50% marks).

2002 X from Lalwani High School, Jamner, and Nasik Board. (Scored 78.52% marks).

Dissertation (as part of M.Pharm Curriculum)

Presented dissertation on “Process Validation of Fexofenadine Hydrochloride and

Pseudoephedrine Hydrochloride Extended Release Tablets” at Dr. Reddy’s Laboratories Ltd.,

Hyderabad.

Trainings

Project Title : Quality Risk Management for tablet drug manufacturing process

Organisation : Jalgaon Chemical Private Limited, Jalgaon.

Period : 16/05/2007 to 15/06/2007

Role : Trainee

IT Skills

Well-versed with Enterprise Resource Planning to handle GMP operations.

Personal Snippets

Date of Birth : 29th October 1986

Address : 302,Building no 6,Gokul Nagari-1,Khadapada,Kalyan West, Thane

Linguistics Abilities: English, Hindi and Marathi

Declaration:

I confirm that the information provided by me is true to the best of my knowledge and belief.

Yours Sincerely,

Atul Mahajan

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