4 - 6 years
2 - 4 Lacs
Posted:2 weeks ago|
Platform:
On-site
Full Time
JD -
Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support.
Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+).
QMS Ownership: Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment.
Documentation Control: SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP.
Vendor & Material Quality: Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability.
Training & Compliance: Conduct/track GMP and GDP trainings; maintain training matrices.
Quality Risk Management: Participate in risk assessments (FMEA/HACCP) and mitigation plans.
Change Implementation: Partner with Production, QC, and Engineering to implement approved changes without compliance gaps.
Metrics & Reporting: Maintain QMS KPIs; present trends to management.
EHS & Data Integrity: Enforce site safety and DI requirements; escalate non compliances
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