Objective Of The Role To conduct risk-based, systemic internal audits across sites and functions, ensuring effectiveness of the Quality Management System (QMS), regulatory compliance, and identification of systemic gaps, with a strong focus on continuous improvement and inspection readiness.

- Audit Planning &
- Execution

- Prepare annual and risk-based audit plans and develop Audit agendas

- Site-specific audit checklists and focus areas based on risk signals

- Lead: Opening and closing meetings

- Ensure: Explicit, concise, and evidence-based audit observations

- Audit Reporting &

- Follow-up

- Prepare high-quality audit reports with Risk classification (Critical/Major/Minor) Systemic observations

- Track: CAPA commitments and timelines and evaluate CAPA effectiveness.

- Escalate critical gaps to management

- Systemic Gap Assessment (Six Systems Approach)

- Conduct audits based on Six Systems of Quality: Quality System, Production System, Laboratory Control System, Materials System, Facilities &

- Equipment System and Packaging &
- Labelling System





- Perform deep-dive systemic evaluations rather than checklist-based audits

- Identify root causes and interdependencies across systems

- QMS elements (Deviation, CAPA, Change Control, OOS/OOT)

- Ability to “Connect the Dots”

- Correlate findings across: Deviations, OOS/OOT, complaints, audit observations

- Identify: Recurring trends, Hidden systemic failures, Weak quality culture signals

- Evaluate end-to-end data flow for data integrity risks (ALCOA+)

- Provide holistic audit conclusions beyond individual observations

- GCAPA (Global CAPA) Assessment

- Review and assess Global CAPA effectiveness across sites

- Implementation status across multiple locations

- Ensure: Horizontal deployment of CAPA Effectiveness and sustainability

- Warning Letter (WL) &

- USFDA 483 Evaluation

- Perform detailed evaluation of: USFDA 483 observations and Warning Letters

- Assess applicability to internal sites: Gap assessment vs current practices

Translate regulatory observations into: Internal audit focu

📌 MANAGER -INTERNAL AUDITOR- QMS SYSTEMS (Navi Mumbai)
🏢 Alkem Laboratories
📍 Navi Mumbai