Group Company: Enzene Biosciences Ltd

Designation: Senior Executive

Office Location: Chakan, Pune

Responsibilities -

- Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnel’s and evaluation of effectiveness.
- Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines.
- Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance’s.
- Responsible for Prepare and review of documentation such as SOP’s, Specifications, STP’s, TDS, reports for IRS, of protocols, Qualifications and reports analyst qualification, etc.
- Responsible for investigations and review of OOS, OOT and deviations. To recommend and review CAPA, change controls.
- Responsible for review calibration and validation documents of instruments and equipment’s.
- Responsible for review the analytical data and reports of samples handled in quality control laboratory.




- Ensure compliance and adherence to data integrity.
- Responsible for prepare and review of stability protocols, stability study summary reports, stability trends, stability calendar, stability analysis reports and stability matrix.
- Responsible for the review and approval of current software implementation and related documentation.
- Responsible to prepare review of calibration matrix and planner.
- Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and laboratory incidents).
- Responsible for the preparation and review of audit responses (Internal and External).
- Responsible for monitoring of batch planning and execution to meet the batch release and stability release on-time or as per requirement.
- Responsible for reviewing of logbooks.
- Responsible for general place cleanliness and adherence of SOP / documents as per defined system.
- Responsible for work assigned by immediate supervisor.
- Responsible for the works carried out in absence of the designee.

Education: MSc/ M Pharma/ M Tech/ Masters in related field

Required Skills: Knowledge of Analytical techniques, expertise in QMS

📌 QC - QMS & Compliance (Pune)
🏢 Enzene Biosciences
📍 Pune