Senior Executive - Quality Assurance

Ensure GMP compliance in drug product manufacturing, filling, and packaging operations.

Monitor shop floor activities, including dispensing, in-process checks, filling, visual inspection, and AQL.

Plan and allocate IPQA manpower as per production schedules and provide real-time QA support for batch execution.

Review and approve QMS elements (Deviation, CAPA, Change Control, OOS, Market Complaints).

Perform review of batch records (BPR/BPR), EM reports, validation documents, and technical data.

Participate in investigations, risk assessments, and mitigation planning.

Support regulatory inspections, internal audits, and customer audits, ensuring audit readiness at all times.

Review Media Fill, Process Validation, Cleaning Validation, and ensure equipment & area qualification compliance.

Ensure training, qualification, and development of IPQA personnel