Executive/ Senior Executive - QMS & Compliance

Enzene Biosciences Ltd.; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a Senior Executive/Deputy Manager level professional to lead QC analytical activities with emphasis on QMS compliance. The role involves training QC personnel, ensuring GMP and regulatory adherence, and driving CAPA across audits and deviations.

Candidates should have hands-on experience in biologics or related biopharmaceuticals, with familiarity in deviations, change control, OOS/OOT, and documentation closure within a robust QMS environment.

Qualifications

• Experience in QC Analytical / Bioassay with hands-on QMS compliance responsibilities.
• Experience in Biologics, Biosimilars, Vaccines or other Biopharmaceuticals.
• Practical experience in deviations, CAPA, change control, OOS/OOT, audits, documentation and QMS closure.
• Experience preparing/reviewing quality documents and ensuring GMP and data integrity compliance.

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 new software implementation and ensure adherence to applicable procedures.

Skills

QC analysis

QMS compliance

Biologics knowledge

Deviations & CAPA

Job description

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 new 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.