AGM/DGM- CQA

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 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.

Qualifications & Experience

• 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.

Core Competencies

• 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

. Skillset Required: Internal Audits, Data Integrity, Sterility Assurance, cGMP, Global Regulatory Compliance, Pharmaceutical Quality System, Risk-Based Quality Oversight, Continuous Improvement, CAPA Closure, Data Integrity Governance, DIRA, ALCOA++ Compliance, DI Investigations, Computerized Systems Oversight, CCS, Aseptic Processing, Media Fills, Sterilization Validation, Environmental Monitoring, Contamination Control, Regulatory Inspections, US FDA, EU GMP, WHO, MHRA, PIC/S Compliance, Training Delivery, Trend Analysis, Risk Management, Cross-Functional Initiatives, ICH Q9, ICH Q10, ALCOA++, CAPA, RCA, FMEA, Validation, Aseptic Processing, Computerized Systems, Inspection Readiness, Strategic Leadership, Risk-Based Decision-Making, Communication, Collaboration, People Development