Quality Assurance Associate - Drug Substance

Job Description:

Responsibilities

• Oversee the qualification, documentation, and traceability of Master and Working Cell Banks (MCB/WCB).
• Ensure compliance with GMP, EU Annex 1, and ICH guidelines for cell bank handling, storage, and distribution.
• Review and approve cell bank-related protocols, COAs, and characterization reports.
• Monitor environmental conditions and alarm systems for cell bank storage units (LN2 tanks, freezers).
• Support audits and regulatory inspections by providing cell bank documentation and responses.
• Coordinate with manufacturing, QC, and regulatory teams to ensure cell bank readiness for production.
• Manage deviations, CAPAs, and change controls related to cell bank operations.
• Issue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requirements.
• Batch Production Record (BPR) Review & Documentation
• Review executed Drug Substance (DS) BPRs and associated documents for all products.
• Ensure timely deposition of reviewed documents to the DCQA.

Qualification & Experience  

• Educational qualification: M.sc (Life Science) /M Pharm 
• Minimum work experience: 4-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars