Job Opportunity: QA – Document Coordinator at Zydus Lifesciences- Apply before  31st July 2024

Job Responsibilities

Document Management:

1. Prepare, review, and control the quality document management system.
2. Archive master documents and secure the soft copies of master documents.
3. Issue copies of master documents (SOPs, Batch records) to departments such as warehouse, quality control, production, engineering, and HR.
4. Retrieve obsolete/superseded document copies from different functions.
5. Retain all completed documents and records in the document storage room with proper indexing.
6. Ensure the destruction of documents upon receiving appropriate authorization.
7. Provide data/information to regulatory affairs for DMF/dossiers/product registration applications with regulatory authorities in target markets.

Retain Sample Management:

8. Ensure storage, maintenance, and destruction of control samples.
9. Issue control samples upon authorization by the QA head with proper justification.
10. Perform periodic reviews of control samples.
11. Monitor stability results and circulate reports to Corporate QA, PTC, and RA as applicable.
12. Inform management about any quality issues.
13. Implement company quality ethics policy for data integrity and inform management and the data integrity compliance head of any data integrity issues as per corporate data governance policy.

Technology Transfer (Receiving) and Process Validation:

14. Verify the completeness, relevance, and scientific basis of data/information in Technology Transfer documents per applicable guidelines.
15. Implement company quality ethics policy for data integrity and inform management and the data integrity compliance head of any data integrity issues as per the data governance quality policy.
16. Review and approve the Validation Master Plan.
17. Ensure SAP-related activities such as code creation, BOM creation, and specification uploading are completed.
18. Review deviations/incidents and change control proposals for facility, equipment, and equipment shifting, and evaluate validation requirements through risk assessment.
19. Provide information required for the preparation of the Annual Product Review regarding validation.
20. Review and approve BMR/BPR of engineering batches.
21. Perform sampling at different stages of engineering batches.
22. Review recommendations for manufacturing PPQ batches based on engineering batch learnings.
23. Review and approve engineering batch reports.
24. Conduct failure investigations in exhibit/engineering and PPQ batches.
25. Review and approve failure investigation reports.
26. Review and approve PPQ protocols and reports, verify executed data, and review summary reports.
27. Perform sampling as per PPQ protocol and monitor PPQ batches.
28. Review and approve change control for process validation and ensure comprehensive documentation.
29. Check summary reports prepared post-process validation completion.
30. Execute technology transfer activities from site to site as per quality policy on technology transfer of drug products.
31. Review and ensure technology transfer of products at site and prepare summary reports post-completion of engineering and exhibit batches.
32. Archive documents submitted by PTC, pre-exhibit/exhibit batches, and analytical method/process validation, and submit copies for dossier submission to IRA as per future marketing strategies.
33. Review data from exhibit batches, engineering batches, and PV batches, and ensure CQA, CMA, and CPP learnings are transferred to subsequent stages.

APQR-RA Support:

34. Prepare and review annual product quality reviews to ensure compliance with SOP and regulatory requirements.
35. Support and review required documents for regulatory affairs team filings.
36. Ensure the APQR program is completed on time and per the established schedule.
37. Ensure data truthfulness in all assigned activities.
38. Extract and compile data on analytics, manufacturing (including deviations, complaints, and change requests), and regulatory data, collect stability data and reports for product evaluations, variations, and market authorizations as per APQR/PQR site SOP.
39. Oversee the APQR/PQR report process, flag delays, and resolve and assign follow-up actions.
40. Implement company quality ethics policy for data integrity and inform management and the data integrity compliance head of any data integrity issues as per data governance policy.

Change Control:

41. Log change controls in Trackwise/applicable systems.
42. Review and approve Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports for plant equipment and facilities.
43. Review and approve User Requirement Specifications.
44. Review all supplier/in-house documents required for equipment, utilities, and process qualification.
45. Execute, review, and approve requalification/periodic qualification protocols and reports for equipment, utilities, and areas.
46. Review and approve final validation/qualification reports.
47. Coordinate validation activities with engineering, production, IPQA, formulation development, and quality control departments.
48. Compile, review, and approve qualification protocols and reports with production, quality control, regulatory affairs, and formulation development departments.
49. Prepare and review the Validation Master Plan, Cleaning Validation Master Plan, and Equipment Qualification Master Plan at the site.
50. Perform sampling as per cleaning validation protocol.
51. Prepare, execute, review, and approve cleaning/equipment validation/verification protocols and reports and assess and evaluate studies with production/engineering and quality control departments.
52. Evaluate relevant change control forms, temporary change control forms, incident forms, and deviation forms.
53. Implement company quality ethics policy for data integrity and inform management and the data integrity compliance head of any data integrity issues as per the data governance quality policy.

Candidate Profile

• Knowledge and experience in regulatory audits.
• Experience with regulatory audits such as USFDA, MHRA, MCC, and ANVISA.

Additional Information

• Experience: 03 – 06 years
• Qualification: B.Pharm / M.Pharm
• Location: Zydus Lifesciences Limited, Changodar (Topical), Ahmedabad
• Industry Type: Pharma/Healthcare/Clinical Research
• End Date: 31st July 2024
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