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.

Solid 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

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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

Required Skill Profession

Other General

📌 AGM/DGM CQA (Hyderabad)
🏢 Talental Consultings
📍 Hyderabad