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Manager- Quality Assurance

Manager- Quality Assurance

IBM

5 - 10 years

7 - 12 Lacs

mumbai

Posted:5 hours ago| Platform:

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Skills Required

qa manager quality assurance project management pharma quality audit contract manufacturing gmp regulatory affairs operations quality compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Looking for Quality Assurance professionals for a globally leading Pharmaceutical Client, responsible for managing all the quality related aspects at the external suppliers/ contract manufacturing sites. Key deliverables are as follows :

Lead supplier qualification process

Lead for Technical Meetings

Assessing quality assurance agreements

Single point of contact for all the quality related activities at external suppliers.

Quality compliance w.r.t GMP environment, regulatory affairs, adherence to quality manual

Quality Auditing, change requests,

Supplier Relationship Manager

Willing to travel extensively to all the contract manufacturing sites in India

Ideal Background for the candidate :

10 or more years experience in the pharmaceutical industry, with direct experience with APIs.

Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.Strong understanding of regulatory requirements for commercial products.

Proven track record with FDA, EMEA and other Health Authorities.

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