Senior Manager - QA Sterile QMS
Senior Manager - QA Sterile QMS
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Job Description
Oversee and manage QMS processes including Deviation Management CAPA Change Control Risk Management and Product Quality Reviews (PQRs).
Lead Quality investigations and root cause analysis for process deviations and quality events.
Ensure timely closure of audit observations and effective CAPA implementation.
Monitor and review QMS KPIs and drive continuous improvement initiatives.
Coordinate and lead internal and external audits (regulatory and customer).
Ensure sterile area compliance through regular review of processes documentation and trending of quality data.
Lead training initiatives related to QMS and GMP for the QA and production teams.
Collaborate with crossfunctional teams (Production QC Regulatory Affairs etc. to ensure QMS effectiveness and product quality.
Review and approve master documents related to QMS (SOPs protocols reports).
Support data integrity initiatives and ensure compliance with ALCOA principles.
Maintain readiness for regulatory inspections and support inspection management activities.
Required Experience:
Senior Manager
Employment Type
Full-Time
