Job Description
Head – Internal Audit, Data Integrity & Sterility Assurance (AGM/DGM)
Department: Corporate Quality Assurance (CQA)
Reports To: Head – Corporate Quality
Job Purpose
Lead the organization's Internal Audit, Data Integrity, and Sterility Assurance programs to ensure cGMP and global regulatory compliance while strengthening the Pharmaceutical Quality System through risk-based quality oversight and continuous improvement.
Key Responsibilities
Develop and execute the annual risk-based internal audit program and ensure effective CAPA closure.
Lead Data Integrity (DI) governance, DIRA, ALCOA++ compliance, DI investigations, and computerized systems oversight.
Oversee Sterility Assurance through audits of CCS, aseptic processing, media fills, sterilization validation, environmental monitoring, and contamination control.
Support regulatory inspections and ensure complianc...