QA - QMS - Dy. Manager
QA - QMS - Dy. Manager
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Job Description
Manufacturing Investigations: Lead and guide root cause analysis (RCA) for deviations batch failures OOS/OOT results and ensure implementation of robust Corrective and Preventive Actions (CAPA).
Complaint & Recall Handling: Manage market complaint investigations initiate product recall processes coordinate with cross-functional teams and ensure timely closure with regulatory and customer communication.
Risk Assessments: Drive preparation review and periodic update of Nitrosamine and Elemental Impurity risk assessments in line with global regulatory expectations (e.g. EMA USFDA ICH).
Documentation & Review: Ensure accurate and timely documentation of investigations risk evaluations and QMS records as per ALCOA principles.
Compliance & Audit Readiness: Ensure readiness for regulatory inspections (USFDA MHRA WHO EU-GMP) by maintaining a robust and audit-ready QMS framework.
Training & Implementation: Train personnel in QMS procedures investigation techniques and risk-based approaches across departments.
QMS Improvements: Support continuous improvement by analyzing trends from deviations complaints and CAPAs and driving system enhancements.
Required Experience:
Manager
Employment Type
Full-Time
