Group Company: Enzene Biosciences Ltd

Designation: Senior Executive

Office Location: Chakan, Pune

Responsibilities -

1. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnel’s and evaluation of effectiveness.
2. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines.

3. 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.

1. Responsible for investigations and review of OOS, OOT and deviations. To recommend and review CAPA, change controls.
2. Responsible for review calibration and validation documents of instruments and equipment’s.
3. Responsible for review the analytical data and reports of samples handled in quality control laboratory.
4.



Ensure compliance and adherence to data integrity.
5. Responsible for prepare and review of stability protocols, stability study summary reports, stability trends, stability calendar, stability analysis reports and stability matrix.
6. Responsible for the review and approval of recent software implementation and related documentation.
7. Responsible to prepare review of calibration matrix and planner.
8. Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and laboratory incidents).
9. Responsible for the preparation and review of audit responses (Internal and External).
10. Responsible for monitoring of batch planning and execution to meet the batch release and stability release on-time or as per requirement.
11. Responsible for reviewing of logbooks.
12. Responsible for general place cleanliness and adherence of SOP / documents as per defined system.
13. Responsible for work assigned by immediate supervisor.
14. 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