QC - QMS & Compliance

Enzene Biosciences Ltd; Maharashtra; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Enzene Biosciences Ltd is seeking a Senior Executive to drive quality assurance and regulatory compliance at our Chakan, Pune facility. The ideal candidate will oversee training programs related to quality, GMP and regulatory standards for the quality control laboratory team.

The role involves conducting periodic assessments, audits, CAPA implementation, and reviewing critical documentation such as SOPs, STPs, TDS and reports.

Qualifications

• Knowledge of analytical techniques and QMS is essential.
• Experience with quality systems, audits, CAPA and change controls is preferred.
• Familiarity with GMP, regulatory guidelines and data integrity requirements.

Responsibilities

• Conduct periodic training for quality, GMP and regulatory aspects to QC laboratory personnel and evaluate effectiveness.
• Ensure compliance with internal, external, and statutory guidelines per Enzene’s policies.
• Lead audits, identify gaps, prepare CAPA and coordinate cross-functional remediation.
• Review SOPs, specifications, STPs, TDS and analytical reports; ensure accuracy and adequacy.

Skills

Analytical techniques

QMS expertise

Education

MSc/MPharma/MTech

Masters in related field

Job description

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.

4. 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.

5. Responsible for investigations and review of OOS, OOT and deviations. To recommend and review CAPA, change controls.

6. Responsible for review calibration and validation documents of instruments and equipment’s.

7. Responsible for review the analytical data and reports of samples handled in quality control laboratory.

8. Ensure compliance and adherence to data integrity.

9. Responsible for prepare and review of stability protocols, stability study summary reports, stability trends, stability calendar, stability analysis reports and stability matrix.

10. Responsible for the review and approval of new software implementation and related documentation.

11. Responsible to prepare review of calibration matrix and planner.

12. Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and laboratory incidents).

13. Responsible for the preparation and review of audit responses (Internal and External).

14. Responsible for monitoring of batch planning and execution to meet the batch release and stability release on-time or as per requirement.

15. Responsible for reviewing of logbooks.

16. Responsible for general place cleanliness and adherence of SOP / documents as per defined system.

17. Responsible for work assigned by immediate supervisor.

18. Responsible for the works carried out in absence of the designee.

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.

4. 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.

5. Responsible for investigations and review of OOS, OOT and deviations. To recommend and review CAPA, change controls.

6. Responsible for review calibration and validation documents of instruments and equipment’s.

7. Responsible for review the analytical data and reports of samples handled in quality control laboratory.

8. Ensure compliance and adherence to data integrity.

9. Responsible for prepare and review of stability protocols, stability study summary reports, stability trends, stability calendar, stability analysis reports and stability matrix.

10. Responsible for the review and approval of new software implementation and related documentation.

11. Responsible to prepare review of calibration matrix and planner.

12. Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and laboratory incidents).

13. Responsible for the preparation and review of audit responses (Internal and External).

14. Responsible for monitoring of batch planning and execution to meet the batch release and stability release on-time or as per requirement.

15. Responsible for reviewing of logbooks.

16. Responsible for general place cleanliness and adherence of SOP / documents as per defined system.

17. Responsible for work assigned by immediate supervisor.

18. 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