Senior Executive QA – Drug Substance (DS)

About the role

The Senior Executive QA will ensure cGMP compliance on the shop floor for drug substance (DS) manufacturing. You will oversee line clearance, in‑process checks, documentation review and quality system activities to maintain regulatory readiness.

Key responsibilities

• Perform manufacturing line clearance and verify in‑process checks for DS activities.
• Conduct routine GMP rounds, document observations and follow up on corrective actions.
• Review online batch manufacturing records (BMR) for accuracy, completeness and compliance.
• Approve and review process validation and cleaning validation protocols and reports.
• Manage SOPs, protocols and reports related to shop‑floor operations.
• Coordinate sample collection and submission per BMR, specifications, validation and stability protocols.
• Support preparation of Annual Product Quality Review (APQR/PQR) documents.
• Initiate and manage Change Control, Deviations, Incidents and CAPA, ensuring timely closure.
• Participate in QMS investigations, root‑cause analysis and risk assessments for critical processes.

Required profile

• 6‑9 years of experience in Quality Assurance within drug substance manufacturing.
• M.Sc or M.Pharm degree.
• Strong knowledge of cGMP, QMS and global regulatory guidelines (USFDA, EMA, WHO preferred).
• Hands‑on experience with DS/DP shop‑floor QA activities and documentation control.

Required skills

• cGMP compliance
• Quality Management System (QMS)
• Process validation
• Cleaning validation
• In‑process controls
• Batch Manufacturing Record (BMR) review