Executive - Quality Assurance

About the role

The Executive – Quality Assurance ensures that manufacturing and warehouse operations comply with Good Manufacturing Practices (GMP), regulatory requirements, and approved procedures. The role supports investigations, corrective actions, and continuous improvement across the site.

Key responsibilities

• Visit DS manufacturing and warehouse facilities to verify GMP and regulatory compliance.
• Participate in manufacturing investigations and finalise CAPA activities.
• Prepare and review risk assessments and mitigation plans.
• Oversee process and cleaning validation activities according to approved protocols.
• Review master documents such as study protocols, BPR, MFR and ensure SOPs meet GMP standards.
• Audit executed batch processing records for release and verify batch dispatch activities.
• Coordinate APQR data compilation and preparation.
• Develop and review Quality System SOPs and related documentation.

Required profile

• 3‑5 years of experience in quality assurance within a regulated manufacturing environment.
• Master’s degree in Biotechnology or a postgraduate qualification in Pharmacy or Pharmaceutical Technology.
• Strong understanding of GMP, CAPA, risk assessment, and validation processes.

Required skills

• GMP compliance
• CAPA management
• Risk assessment and mitigation
• Process and cleaning validation
• Document review (protocols, SOPs, batch records)
• APQR compilation