Quality Assurance-Micro

Role & responsibilities

1. Review of all microbiological documents and reports including but not limited to BET ,Sterility,Bioburden,GPT records ,MLT, LBPC,KTA Vitek-2 & Vitek-MS data, water testing records, log books, electronic data & other miscellaneous records/ reports.

2. Review , approval pf microbial test reports & environment monitoring data.

3. Review of protocol, reports for various study and validation & qualification study.

4. Review of Notification/Excursions,Investigation ,Deviations,events,OOS,OOT,trends,summary report and other QMS Documentation.

5. Issuance ,control,retrieval ,retention,and destruction of documents like specification,SOPs and their formats,test data sheets,validation protocol and their formats, logbooks,qualification formats,batch manufacturing records,batch packaging record and FP reports etc.

6. Ensure witness activities,media plates release and visual inspection activities.

7. Ensure plates reconcillation and issuance verification.

8. Review and ensure completeness of media preparation records,GPT records,Biological test records and other Miscellaneous records/reports.

9. Monitor all aspects of manufacturing,processing,packaging,and stop operations, if required to ensure compliance with established procedure and cGMP norms.

10. To ensure that training of self is completed on time.

11. To ensure compliance to safety, quality, ethical conduct and data integrity policy and to escalate any potential risk or suspected DI violation to the management as per ECDI policy.

12. Participate in process validations and cleaning validation, Media fill, management reviews of process performance, Stability management.

13. Issue QMS documents.

14. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to QA head/Designee

15. Ensure timely completeness of microbiological activities and documents as per GLP/GDP.

16. Verification of visual inspection for media filled units and review of visual inspection records

17. To Initiate QMS documents as per defined procedure.

18. To provide input/prepare departmental SOPs as per guidance.

19. To follow SOP, BMRs, BPRs, policies, protocols and guidance documents.

20. To perform any activity assigned by Supervisor/manager/Lead on timely basis.