AGMDGM CQA(Sterility Assurance, Internal Audits, Data Integrity)

Department: Corporate Quality Assurance (CQA)
Reports To: Head – Corporate Quality

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.

• 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 compliance with US FDA EU GMP WHO MHRA and PIC/S requirements.

• Deliver training on Internal Audits DI Sterility Assurance and cGMP while promoting a quality culture.

• Drive quality improvements through trend analysis risk management and cross-functional initiatives.

• Bachelor's/Master's degree in Pharmacy Microbiology Biotechnology or Life Sciences.

• 15–20 years of sterile pharmaceutical manufacturing experience.

• 4–5 years of leadership experience in QA/Corporate Quality.

• Strong expertise in Internal Audits Data Integrity Sterility Assurance Regulatory Inspections and Quality Systems.

• cGMP ICH Q9/Q10 ALCOA CCS

• Internal Audits CAPA RCA FMEA

• Validation Environmental Monitoring Aseptic Processing

• Computerized Systems Inspection Readiness

• Strategic leadership risk-based decision-making communication collaboration and people development