Zydus Lifesciences Hiring QA Document Coordinator

After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.

Post : QA - Document Coordinator

Job Responsibilities
Document Management :
1. Preparation, review and control of quality document management system.
2. To archive master documents and ensure security of the soft copy of the master Documents
3. To issue copies of the master document (SOPs, Batch records) as required to other departments such as warehouse, quality control, production, engineering and HR function etc.
4. To retrieve the obsolete /superseded copies of the documents distributed to different Functions.
5. To retain all completed documents and records in document storage room with
adequate indexing.
6. To ensure the destruction of documents when appropriate authorisation has been provided.
7. To issue and submit the data /information to regulatory affairs for preparation of DMF/dossiers/application for registration of the products with regulatory authority of the countries, intended to market the product.

Retain Sample Management :
8. To ensure storage, maintenance and destruction of the control samples
9. To issue control sample upon authorisation by QA head with proper justification.
10. To perform periodic review of control sample.
11. To monitor the stability results and circulate the reports to Corporate QA, PTC and RA as applicable.
12. To inform Management on quality issue (if any).
13. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.
Technology Transfer (receiving) and Process Validation:
14. To verify the data / information provided in the Technology transfer document for its completeness, relevance and scientific basis, as per applicable guidelines.
15. Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues and per data governance quality policy.
16. To review and approve the Validation Master Plan.
17. To ensure that SAP related activities such as code creation, BOM creation, specification uploading etc. is completed.
18. To review the deviation / incidences, Change Control proposals for facility, equipment, equipment shifting and evaluate Validation requirements through risk assessment.
19. To provide information required for the Preparation of Annual Product Review with regards to Validation.
20. Review and approval of BMR/BPR of Engineering Batch.
21. Sampling at different stages of Engineering Batch.
22. Review of recommendation given for manufacturing of PPQ batches based on learning from Engineering batch.
23. Review and Approval of Engineering Batch Report.
24. Carrying out failure investigation in exhibit/engineering and PPQ bathes.
25. Review and approval of failure investigation report.
26. To review and approve PPQ protocol and report to verified the executed data and review summary report.
27. To do sampling as per PPQ protocol and monitoring of PPQ batches.
28. To review and approve change control for process validation and to ensure contemptuous documentation.
29. To check the summary reports prepared post completion of the process validations issues.
30. To execute technology transfer activity from site to site as per quality policy on technology transfer of drug product from site to site.
31. To review and ensure Technology Transfer of Products at site and ensure preparation of Summary report post completion of Engineer and Exhibit batches.
32. To ensure the archival of the documents submitted by PTC, of Pre Exhibit /Exhibit batches and Analytical Method validation, Process validation etc. And submit the copy of the same for dossier submission to IRA as per the plan for future marketing strategies.
33. To review the data of exhibit batch, engineering batch and PV batches, and to ensure that learning of CQA, CMA and CPP get transferred to sub-sequent stages

APQR-RA Support :
34. To prepare and review annual product quality review of the products and ensure compliance to SOP and regulatory requirements.
35. To support and review required documents for filing by regulatory affairs team.
36. Responsible for APQR program ensuring all reviews are prepared and completed on time and as per established schedule.
37. To remain all time alert and responsible to ensure truthfulness of data for area of assigned activity as doer or checker.
38. Responsible for extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data, collecting stability data and reports for product related evaluations, variation and market authorization if any as per APQR/PQR site SOP.
39. Responsible for APQR/PQR Report, flag any delays on time; also to resolve and assign follow-up action items.
40. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per data governance policy.

Change Control :
41. To log the change control in Trackwise/ in applicable system. Cleaning validation, equipment, utility qualification cell:
42. Review and approval of Installation Qualification, Operational Qualification and performance Qualification protocols and Reports of entire plant equipment & facilities.
43. Review and approval of User Requirement Specification
44. Review of all supplier/in house documents required for qualification of Equipment, utilities and process.
45. Execution, review and approval of requalification/Periodic qualification of mapping study protocols and of equipment, utilities and area.
46. Review and approval of final validation/Qualification reports.
47. Coordinating the validation activities with Engineering, production, IPQA, formulation development department, other user department and Quality control departments.
48. Compilation, review and approval of Qualification protocols and reports in co-ordination with production, Quality control, regulatory affairs, formulation development department.
49. Preparation and review of Validation Master Plan, Cleaning validation Master plan and Equipment Qualification master plan at site.
50. To perform the sampling, wherever applicable as per cleaning validation protocol.
51. Preparation, execution, review and approval of cleaning/equipment validation/verification protocols and reports as well as assessment and evaluation of study in co-ordination with production/engineering and quality control department.
52. To evaluate relevant change control forms, temporary change control forms, Incident forms and deviation forms.
53. Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per data governance quality policy.

Candidate Profile
• Must have knowledge and experience in regulatory audit
• Should have faced regulatory audits like USFDA, MHRA, MCC and ANVISA etc.

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