Role & responsibilities
Manage quality, GMP and regulatory training for QC laboratory personnel, including effectiveness evaluation.
Ensure compliance with internal, external and statutory requirements, pharmacopoeial standards and applicable regulatory guidelines.
Conduct periodic assessments and audits, identify compliance gaps, and drive CAPA and remediation plans.
Prepare and review SOPs, specifications, STPs, technical documents, protocols, qualification documents and analytical reports.
Handle and review OOS, OOT, deviations, laboratory incidents, CAPA and change controls, ensuring timely closure in the QMS.
Review calibration and validation documents, analytical data, stability protocols/reports/trends, logbooks and calibration planners.
Ensure data integrity, audit readiness, timely batch/stability release and compliance with established quality systems.




Review and approve documentation related to recent software implementation and ensure adherence to applicable procedures.

Preferred candidate profile
Experience in QC Analytical / Bioassay along with hands-on QMS Compliance responsibilities is essential.
Candidates must have experience in Biologics, Biosimilars, Vaccines or other Biopharmaceuticals.
Practical experience in deviations, CAPA, change control, OOS/OOT, audits, documentation and QMS closure is preferred.
Candidates should have experience in preparing/reviewing quality documents and ensuring GMP and data integrity compliance.
Suitable for candidates at Senior Executive or Deputy Manager level, depending on relevant experience and responsibilities.

📌 Executive/ Senior Executive Qms & Compliance Pune
🏢 Enzene
📍 Pune