PINAKI ROY

Mobile: 983*******/ 980-***-**** ~ E-Mail: ado2pp@r.postjobfree.com/ado2pp@r.postjobfree.com

Seeking career in Quality Assurance in a reputed organisation preferably in Kolkata

CAREER OVERVIEW

MSc (Organic Chemistry) professional with over 9 years of experience in Quality Assurance, Lab Operations, Plant Operations coordinating with team members and enhancing the process operations.

Acquired comprehensive exposure in planning and organizing day-to-day research & development, QA activities and executing tasks on a timely basis.

Acquired training on ICH Quality Guidelines, DMF Filling with USFDA, Regulatory Submission to NABL.

TECHNICAL SKILLS

Possessing knowledge of:

ICH Quality Guidelines.

GMP,GLP, HACCP,OHSAS

DMF Preparation, Filing with USFDA.

Regulatory Submission to NABL, EU- EDQM, &other Agencies.

EMPLOYMENT RECITAL

Nov 2014 to Apr 2019

Edward Food Research Analysis Centre (EFRAC) as Quality Assurance Executive

Key Deliverables:

Report release and review of documents.

Preparing SOP and other quality documents.

Handling OOS, Incident, Deviations, CAPA.

Regulatory Submission to NABL, OHSAS, BIS etc.

Maintaining Calibrations

NC Closure and other Quality Assurance related activities.

Document Maintaining.

Feb 2013 to Feb 2014

GRM TECH Pvt ltd Kolkata as IMA

Key Deliverables:

Off Page SEO.

Oct 2011 to May 2012

Eskag Pharma Pvt ltd. Kolkata as R&D chemist (API)

Key Deliverables:

Reaction handling.

Analysis by titrations.

Carry the procedure to plant scale from lab scale.

Jan2011-Feb2011

Sharon- Bio Medicines Ltd. Mumbai as senior officer Regulatory affairs (API)

Key Deliverables:

DMF Preparation.

Jan’07- Jan2011

Arch Pharma Labs Ltd. Mumbai as R&D Chemist (API)

Key Deliverables:

Standardize the procedure in lab scale.

Conducting the Isolation & Purification, Lab Scale Experiments and optimizing the reaction parameters.

Setting up, calibrating, operating and maintaining a variety of laboratory equipment as specified by the requirements of the literature search.

Designing of various experiments for the study, documentation of data, data management, literature updates and report presentations.

Carry the procedure to plant scale from lab scale (Plant- glass reactors, SS reactors, centrifuge, nutsche filters etc.)

SCHOLASTICS

2012 PGDBM (Human Resource Management) - Correspondence from Indian School of Business Management (ISBM), Mumbai.

2010 Diploma in Drug Regulatory Affairs (API) from Institute of Pharmaceutical Management (IPM) Mumbai.

2005 M.Sc. (Organic Chemistry) from North Maharashtra University, Jalgaon.

2001 B.Sc. (Chemistry) from North Maharashtra University, Jalgaon.

1998 HSC from Nasik Board.

1996 SSC from CBSE Board.

Software Skills: Conversant with MS-Word, MS-Excel, MS PowerPoint and other Internet Applications.

PERSONAL DOSSIER

Born on : 26th May, 1981.

Gender : Male

Permanent Address : 209 A.C Nath Street P.O- Ichapur Nawabganj, 24 Parganas (N) - 743144, (WB)

Linguistic Abilities : English, Hindi, Bengali and Marathi.

Current CTC : N.A.

Expected CTC : As per company Rules.

Notice Period : Immediate. (Max 7 days)

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