Executive – Quality Assurance

About the role

The Executive – Quality Assurance ensures that all manufacturing and warehouse activities comply with Good Manufacturing Practices (GMP), regulatory standards, and approved procedures. The role supports investigations, corrective actions, and continuous improvement within a biotech manufacturing environment.

Key responsibilities

• Visit DS manufacturing and warehouse facilities to verify compliance with GMP, regulatory requirements, and internal procedures.
• Participate in manufacturing investigations and finalize CAPA (Corrective and Preventive Action) activities.
• Prepare and review Risk Assessment and Mitigation Plans.
• Oversee process and cleaning validation activities according to approved protocols.
• Review master documents such as study protocols, BPR, MFR, and ensure their alignment with quality standards.
• Examine executed Batch Processing Records for batch release and verify batch dispatch records in the warehouse.
• Coordinate APQR data compilation and preparation.
• Develop, review, and maintain Quality System SOPs and related documents across all departments.

Required profile

• 3 to 5 years of experience in quality assurance or related roles within biotech/pharmaceutical manufacturing.
• Master’s degree in Biotechnology.

Required skills

• Good Manufacturing Practices (GMP) compliance
• CAPA management
• Risk assessment and mitigation
• Process and cleaning validation
• Document review (protocols, BPR, MFR, batch records)
• APQR compilation
• SOP development and review

What we offer

• Opportunity to work in a dynamic biotech manufacturing environment.
• Exposure to end‑to‑end quality processes and regulatory compliance.