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.

Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education PG: Any Postgraduate read more

Key Skills Skills highlighted with ‘‘ are preferred keyskills QC AnalyticalHPLCQMS

📌 Executive/ Senior Executive - QMS & Compliance (Pune)
🏢 Enzene
📍 Pune