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: Clear, 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
