Quality Assurance Associate - Drug Substance

About the role

We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

What you'll do

• 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

What you need

• 6–8 yrs of experience
• GMP
• Product knowledge
• Medication administration
• SOP writing
• Documentation
• M.Sc or M.Pharm