Senior Executive-QA

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Senior Executive-QA
Job Description
1. Online review of the batch production records (BMRs / ECRs) in Shop floor.
2. Daily monitoring of plant observations.
3. Verification of various log books for completeness in manufacturing areas.
4. Ensure that deviations are reported online.
5. Verify the compliance of in-process controls before proceeding to next steps.
6. Monitoring that the materials are stored at defined storage conditions and labelled appropriately.
7. Identify and report the potential areas of contamination/ Cross contamination in the site.
8. Verifying the SOPs compliance in shop floor.
9. Responsible for BMR / BPR & Other documents issuance, receipt and review and support to dispatch activities.
10. Responsible to attach in finished good packing activity and ensure the packing is done as per requirement.
11. Handling of the line clearance activity on campaign basis.
12. Reviewing the quality system documents as on when required.
13. Handling of Deviations, Closure of CAPAs within the timeline.
14. Handling of Change controls and same shall be close within the timeline.
15. Prepare/review of Investigation reports, SOPs, protocols, Reports & etc.
16. Preparation of product CPVs and APQR as per the schedule.
17. Responsible to review of Quality Risk Assessments, New BMRs and other documents.
18. Handover the completed documents to QA Archival.
19. Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE Wherever applicable.
20. Observe unsafe acts and conditions and take corrective & preventive actions immediately.
21. Report any incident/accident/near miss /illness to the superiors.
22. Identify unsafe conditions and unsafe acts and report to superiors.
23. Any other job as may be assigned to you from time to time.
Online review of the batch production records (BMRs / ECRs) in Shop floor.
2. Daily monitoring of plant observations.
3. Verification of various log books for completeness in manufacturing areas.
4. Ensure that deviations are reported online.
5. Verify the compliance of in-process controls before proceeding to next steps.
6. Monitoring that the materials are stored at defined storage conditions and labelled appropriately.
7. Identify and report the potential areas of contamination/ Cross contamination in the site.
8. Verifying the SOPs compliance in shop floor.
9. Responsible for BMR / BPR & Other documents issuance, receipt and review and support to dispatch activities.
10. Responsible to attach in finished good packing activity and ensure the packing is done as per requirement.
11. Handling of the line clearance activity on campaign basis.
12. Reviewing the quality system documents as on when required.
13. Handling of Deviations, Closure of CAPAs within the timeline.
14. Handling of Change controls and same shall be close within the timeline.
15. Prepare/review of Investigation reports, SOPs, protocols, Reports & etc.
16. Preparation of product CPVs and APQR as per the schedule.
17. Responsible to review of Quality Risk Assessments, New BMRs and other documents.
18. Handover the completed documents to QA Archival.
19. Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE Wherever applicable.
20. Observe unsafe acts and conditions and take corrective & preventive actions immediately.
21. Report any incident/accident/near miss /illness to the superiors.
22. Identify unsafe conditions and unsafe acts and report to superiors.
23. Any other job as may be assigned to you from time to time.
Bachelor of Science (BSc)