Sr Executive AM QA Documentation
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- Support audits and inspections
- Ensure training on updated documents
- Oversee archival and record management
Qualifications & Experience:
- Bachelor’s/Master’s in Life Sciences / Pharma / Biotechnology
- 5–12 years
- Experience in biologics manufacturing
Skills:
- Strong GMP/GDP & data integrity knowledge
- Familiarity with eDMS (TrackWise Veeva MasterControl)
- Attention to detail audit readiness coordination skills
Required Skills:
QMS Quality Management System EDMS DMS SOP SOP Preparation Document Control Documentation Document Management System Archival Retriva Retrival
