Executive – Quality Assurance (Pharma)

About the role

The Executive – Quality Assurance will ensure that all manufacturing and warehouse activities comply with GMP, GLP, and relevant regulatory standards. You will work closely with production teams to maintain data integrity and support continuous improvement across the site.

Key responsibilities

• Visit manufacturing and warehouse facilities to verify compliance with GMP, regulatory requirements, and approved procedures.
• Participate in manufacturing investigations and drive CAPA closure.
• 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, BPRs, and MFRs.
• Audit batch processing records for release and verify batch dispatch activities.
• Coordinate APQR data compilation and preparation.
• Develop, review, and maintain Quality System SOPs and related documents.
• Ensure SOPs across all departments meet GMP standards.

Required profile

• 1–4 years of experience in IPQA or AQA within a regulated pharmaceutical environment.
• Master’s degree in Biotechnology or postgraduate qualification in Pharmacy.
• Strong understanding of regulatory guidelines (USFDA, MHRA, WHO).

Required skills

• Good Manufacturing Practice (GMP)
• Good Laboratory Practice (GLP)
• Data integrity principles
• USFDA, MHRA, WHO regulatory knowledge
• Process validation
• Cleaning validation
• CAPA management
• Risk assessment and mitigation
• APQR preparation
• SOP development and review