Sr Executive/ AM - QA Documentation

Full-time Other-General

About Client

Leading Biopharma client having Biopharma, API and Formulations Business across regulated markets.

Job Title:  Sr. Executive / AM – QA Documentation (Biologics)

Job Summary:

Responsible for managing GMP documentation systems for biologics manufacturing, ensuring compliance, data integrity, and efficient document lifecycle management.

Key Responsibilities:

• Manage lifecycle of GMP documents (SOPs, BMR/BPRs, protocols, reports)
• Ensure timely issuance, retrieval, archival, and destruction of documents as per defined procedures.
• Review documents for compliance with regulatory guidelines (USFDA, EMA, WHO)
• Handle Change Controls, Deviations, CAPAs, and ensure timely closure
• Maintain document control systems (eDMS) with version and access control
• Su...