Quality Assurance Associate

Job Summary

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.

Key Responsibilities – Drug Substance Quality Assurance (DS-QA)

• Cell Bank Assurance

• 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.

• Document Review & Approval

• Review and approve Master Formula Records (MFRs), BPRs, Bill of Materials (BOMs), Standard Operating Procedures (SOPs), Product Quality Reviews (PQRs), action plans, and other relevant documents for both existing and new products.

• Protocol & Report Evaluation

• Review and approve various protocols and reports, including technology transfer documents related to DS manufacturing processes.

• Quality Systems Oversight

• Initiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions (CAPAs), Change Controls, and Quality Risk Management (QRM) activities.

• Audit Support

• Provide support during internal and external audits.
• Ensure timely closure of audit observations and implementation of corrective actions.

• GMP Compliance Monitoring

• Monitor shop floor activities to ensure compliance with Good Manufacturing Practices (GMP).
• Conduct routine and non-routine spot checks.

• Line Clearance & Critical Activity Oversight

• Provide line clearance for product changeovers and oversee critical activities as per SOPs across DS facilities.

• SOP & Document Management

• Create, revise, and review SOPs, forms, and other DS-QA-related documents as required.

• GMP Record Verification

• Perform periodic verification of GMP records in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

• Qualification & Validation Review

• Review and approve process and cleaning qualification/validation protocols and reports.

• Audit Trail Review

• Review system and process audit trails as per the defined schedule.
• Perform audit trail reviews for equipment.

• Issuance of Cell Banks for  Manufacturing Operation

• Issue Working and Master Cell Banks to Manufacturing as per approved guidelines, ensuring traceability and compliance.

Function: Other
Experience Level: Mid-Senior Level