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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...
About the Role
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...
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