Senior Executive - Quality Assurance

piramalpharma; Mahad; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Executive - Quality Assurance in Maharashtra to lead validation activities, QA documentation, and regulatory compliance ensuring product quality across the drug life cycle.

You will prepare and update the Validation Master Plan, process and computer system validation, and APQRs, while coordinating CAPA, change control, and audit responses with the QA Head and technical teams. Strong QA/QEHS experience is desirable.

Responsibilities

• Preparation and updation of Validation Master Plan (VMP).
• Preparation of Process validation, Computer system validation protocol and report.
• Preparation of product matrix and Cleaning Validation/verification protocol and Report.
• Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
• Preparation of area validation protocol and reports.
• Preparation and review of quality risk assessments.
• Batch Record storage, retrieval & destruction.
• Preparation of APQR.
• Sampling of Bulk and Finished goods.
• Review of production records and Finished Goods verification.
• Online observation of process deviation and effective implementation of CAPA.
• Management of Change Control / CAPA / Incidences.
• Coordinate & maintain change control, deviation records.
• Complaint handling.
• Preparation and updation of Q.A departmental SOPs and loading it in DCS ENSUR 4.2
• To give training as per the Training schedule.
• To coordinate training program of the company along with HR, including on Job Training.
• Documentation Management as per SOP.
• To provide necessary documents / data required by CQA and as per customer\'s requirement.
• Conduct, monitor and review of compliance of Self Inspection Program.
• Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
• Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
• Ensuring avoidance of breach of data integrity in area.
• Implementation of effective sanitation programme in area.
• Adherence to the requirements of EHS norms.
• Execution of various initiatives as are suggested by corporate functions.
• To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
• To implement QEHS policy & objectives.
• To ensure participation and consultation of worker.
• Ensure use of PPE
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
• To ensure work permit system during maintenance activities.
• To implement QEHS continual improvement projects at site and monitor.
• Authorized to prevent improper workplace conditions.
• Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
• Authorised to prepare OH&S performance document.
• Authorised to conduct training of workmens related to OHSMS.
• Planning / Scheduling & execution of Vendor Audits of Raw Material, Excipient & Packaging Material.
• Maintenance, Approval & deletion of MPN linkage with co-ordination with SCM, CQA & MDM team.
• Maintenance of Approved vendor list for Raw & Packaging materials.
• Review of Vendor Performance monitoring record.

Job description

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 - Quality Assurance Job Description

1. 1. Preparation and updation of Validation Master Plan (VMP)
2. 2. Preparation of Process validation, Computer system validation protocol and report.
3. 3. Preparation of product matrix and Cleaning Validation/verification protocol and Report.
4. 4. Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
5. 5. Preparation of area validation protocol and reports.
6. 6. Preparation and review of quality risk assessments.
7. 7. Batch Record storage, retrieval & destruction.
8. 8. Preparation of APQR.
9. 11.Sampling of Bulk and Finished goods.
10. 9. Review of production records and Finished Goods verification.
11. 10. Online observation of process deviation and effective implementation of CAPA.
12. 11. Management of Change Control / CAPA / Incidences.
13. 12. To coordinate & maintain change control, deviation records.
14. 13. Complaint handling.
15. 14. Preparation and updation of Q.A departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2
16. 15. To give training as per the Training schedule.
17. 16. To coordinate training program of the company along with HR, including on Job Training.
18. 17. Documentation Management as per SOP.
19. 18. To provide necessary documents / data required by CQA and as per customer's requirement.
20. 19. Conduct, monitor and review of compliance of Self Inspection Program.
21. 20. Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
22. 21. Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
23. 22. Ensuring avoidance of breach of data integrity in area.
24. 23. Implementation of effective sanitation programme in area.
25. 24. Adherence to the requirements of EHS norms.
26. 25. Execution of various initiatives as are suggested by corporate functions.
27. 26. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
28. 27. To implement QEHS policy & objectives.
29. 28. To ensure participation and consultation of worker.
30. 29. Ensure use of PPE
31. 30. To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
32. 31. To ensure work permit system during maintenance activities.
33. 32. To implement QEHS continual improvement projects at site and monitor.
34. 33. Authorized to prevent improper workplace conditions.
35. 34. Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
36. 35. Authorised to prepare OH&S performance document.
37. 36. Authorised to conduct training of workmens related to OHSMS.
38. 37. Planning / Scheduling & execution of Vendor Audits of Raw Material, Excipient & Packaging Material.
39. 38. Maintenance, Approval & deletion of MPN linkage with co-ordination with SCM, CQA & MDM team.
40. 39. Maintenance of Approved vendor list for Raw & Packaging materials.
41. 40. Review of Vendor Performance monitoring record.