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Alembic Pharmaceuticals
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Senior Manager - Quality Assurance - Injectable Site

Senior Manager - Quality Assurance - Injectable Site

Alembic Pharmaceuticals

10 - 20 years

|

15 - 30 Lacs

Posted:4 weeks ago| Platform:

Apply

Skills Required

Quality Assurance Parenteral Sterile Injectables

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

15 to 20 years of relevant industry experience.
Must have experience working in organizations supplying to the USA and EU markets.
Must have participated in at least 5 successful USFDA audits.
Hands-on experience in sterile formulations, including vials, pre-filled syringes, and ophthalmic solutions.
Exposure to working with isolators is essential.
Comprehensive experience in managing Quality Management Systems, including Change Control, Deviations, CAPA, and Annual Product Quality Reviews (APQR).
Overall responsibility for IPQA activities and batch release processes.
Handling compliance-related activities, including internal audits and external regulatory inspections.
Responsible for the training and development of the quality team.

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Alembic Pharmaceuticals

Pharmaceuticals

Vadodara

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