Prasad Mandrekar
- A Pharmacist with over 21 years of experience in Pharmaceutical Quality Assurance and Compliance,...
Ballymacarbry, Ballymacarbry, Ireland
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Prasad Mandrekar’s Email prasadm@glenmarkgenerics.com
Social Media
Prasad Mandrekar’s Location Ballymacarbry, Ballymacarbry, Ireland
Prasad Mandrekar’s Current Industry Pinewood Healthcare
Prasad Mandrekar’s Prior Industry Celltrion Pharm | Glenmark Pharmaceuticals | Cipla | Indoco Remedies
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Work Experience
Pinewood Healthcare
Head of QA & Compliance
2021-11-01 00:00:00 - Present
Celltrion Pharm
Senior Manager Corporate Quality Assurance (Compliance)
2017-12-01 00:00:00 - 2021-09-01 00:00:00
Glenmark Pharmaceuticals
Senior Manager Quality Assurance (Head of QA)
2004-09-01 00:00:00 - 2017-12-01 00:00:00
Cipla
Management Staff
2003-09-01 00:00:00 - 2004-06-01 00:00:00
Indoco Remedies
Management Trainee
2003-05-01 00:00:00 - 2003-08-01 00:00:00Skills
Languages
FAQ About Prasad Mandrekar
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Prasad Mandrekar is located at
Ballymacarbry, Ballymacarbry, Ireland -
Prasad Mandrekar is a - A Pharmacist with over 21 years of experience in Pharmaceutical Quality Assurance and Compliance, managing site and corporate teams (Team size>40) - A Qualified Person (QP) in the making (undergoing M.Sc. course at the prestigious Trinity College in Dublin 2023/24). -Strong quality assurance professional with an MBA focused in Business-Management. - International Working experience in corporate quality assurance and site QA in regions like Far East Asia, India and across Europe. - Possessing diversified experience in handling Audits -US FDA, MHRA, EMA, HPRA, WHO, MFDS-Korea, MCC, Health Canada, ISO, Lachman Consultants and ANVISA (Brazil). - Expertise in guidelines like ICH, HPRA, USFDA, cGMP, EUGMP, MHRA Orange guide, ISPE, PDA, PIC/s etc. - ISO 14001-2004 Core Team Member, Fire Fighter, First Aider. - A Certified Internal Auditor Quality Management System ISO 9001: 2015 - A Certified GMP Auditor with experience performing more than 60 onsite audits for API manufacturing, Finished product CMO, Contract Laboratories, Packaging suppliers, Service providers in different countries like India, China, Ireland, United Sates of America, South Korea and across Europe. - Audited major pharma companies across the globe like Mylan, Cipla, Zhejiang Huahai, Wockhardt, Laurus, MSN, Divis Labs, KRKA, Chemo, Niche and Unichem. - Expertise in validation & qualification of new equipment & commissioning of new facility (for Solid dosage forms, semi-solid, sterile, Pre-filled syringe injection and Biosimilars). - Awarded the highest recognition-“Chairman’s Excellence Award” in Glenmark for outstanding performance in Quality. - “Chairman’s Excellence Award 2017” for “Best Quality Team” in Glenmark for outstanding performance in Quality. -Awarded the highest recognition-“Pride of Wockhardt Award” for Exemplary Performance in Quality (Pinewood) for FY2023 - Hands on experience with 21CFR Part 11 compliant software like e-DMS, Trackwise, First Doc, Open text, Minitab, SAP ECC 6.0, DocuSign, Serialization-Track and Trace etc.
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Prasad Mandrekar currently works in the Pinewood Healthcare |
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No Languages Available
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Prasad Mandrekar has prior
experience in the following industries:
Celltrion Pharm | Glenmark Pharmaceuticals | Cipla | Indoco Remedies -
Prasad Mandrekar has the following professional experience:
Pinewood Healthcare | Celltrion Pharm | Glenmark Pharmaceuticals | Cipla | Indoco Remedies -
You can view Prasad Mandrekar’s LinkedIn profile at LinkedIn URL
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Prasad Mandrekar’s work email
addresses are
prasadm@glenmarkgenerics.com -
Pinewood Healthcare |
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