Role & responsibilities

- Manage and review OOS (Out of Specification) and OOT (Out of Trend) investigations in accordance with approved procedures.

- Coordinate and conduct investigation of laboratory-related deviations, incidents, and discrepancies.

- Review investigation reports, root cause analysis, impact assessment, CAPA, and effectiveness checks.

- Ensure timely closure of OOS/OOT, deviations, CAPA, and other QMS-related activities.

- Review QC documentation, analytical records, laboratory data, and related quality records for compliance.

- Support preparation, review, and implementation of CAPA arising from investigations, audits, and regulatory observations.

- Ensure compliance with GMP, GLP, GDP, data integrity, and ALCOA+ principles.

- Participate in internal audits, customer audits, regulatory inspections, and compliance activities.





- Review and revise QC SOPs, specifications, test methods, formats, protocols, and other controlled documents.

- Monitor QMS metrics and prepare periodic reports related to deviations, OOS/OOT, CAPA, and laboratory compliance.

- Coordinate with QC, QA, Production, Engineering, and other cross-functional teams for investigation and corrective actions.

- Identify recurring quality issues and support implementation of preventive measures and continuous improvement initiatives.

- Ensure proper documentation, traceability, and timely completion of QMS activities.

- Provide training and guidance to QC personnel on QMS procedures and investigation practices.

📌 Asst Manager & Sr Executive - QC - QMS (Pune)
🏢 MJ Biopharm
📍 Pune