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Lead- Quality Assurance

Lead- Quality Assurance

IBM

5 - 10 years

7 - 12 Lacs

mumbai

Posted:4 days ago| Platform:

Apply

Skills Required

manager quality assurance team management quality assurance lead project management risk assessment pharma contract manufacturing gmp risk management operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Looking for Quality Assurance professionals for a globally leading Pharmaceutical Client, leading 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/ quality risk assessment

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, stability reports

Supplier Relationship Manager

Responsible for Team Management

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.

Strong understanding of risk assessment and risk management fundamentals/tools

Technical understanding of pharmaceutical / biological processes

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