Job Description

Department DetailsRole Summary1. Prepare equipment qualification protocol, execution of protocol and summary report
2. Prepare performance requalification protocol and execution of the protocol according to equipment requalification planner.
4. Issuance of documents.
5. Prepare initial document (e.g. SLIA and URS) and prepare or review qualification document such as IQ, OQ and PQ for new equipment
6. Ensure all equipment are in calibrated and validated state.
7. Ensure status of equipment is available and indicated clearly on the equipment.
8. Report to superior or Engineering/Instrumentation and Automation for any issue for the equipment.
9. Liaise with vendor and SCM for external calibration service and PM service to ensure activities are carried out within the stipulated time.
10. Ensure PM and cleaning of equipment are performed according to approved procedure.
11. Coordinate and communicate with vendor or EM personnel on the PM and Calibration activity.
12. Perform spore population assay for Biological Indicator received from vendor. Incubate and release Biological Indicator result sent by Production.
13. Send new lot received of biological indicator to third lab party for testing.
14. Coordinate with QCM Lab personnel for lab shut down activity, fumigation activity or any major maintenance work.
15. Record and update the test results according to approved procedure.
16. Preparation of SOP, EOP or format related to equipment and instrument in QCM.
17. Initiation of change management for SOP, EOP or format revision or protocol revision.
18. Performs vial inspection during Media Fills activity.
19. Initiate SAP Purchase Requisition (PR) and follow up on Purchase Order (PO) with SCM team for service related item (PM, Calibration, Laundry, etc.) and initiate GRN in the system in the absence of QCM SAP Team personnel or as when required.
20. Ensure all task given conducted according to cGMP guideline, EHS policy, Good Documentation Practice and Best Laboratory Practise.
21. Ensure the testing area in Quality Control Microbiology Laboratory is monitored for temperature, relative humidity (RH) and differential pressure and all the parameter are within the limit.
22. Conduct training on the procedures related to Quality Assurance, Specification, SOPs and EOPs.
23. Maintain the employee personnel record according to Good Documentation Practice (GDP)
24. Ensure all the related activities perform in Quality Control Microbiology Laboratory according to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Documentation Practice.
25. Review water sampling test reports and trending of both Production Drug Product (PDP) and Production Drug Substance (PDS).
26. Responsible for RQ activities of 02-19-DHS-01, 02-19-BOD-02, 02-19-BOD-03, 03-07-WII-02 and 02-19-DER-01 (but not limited to).Key Responsibilities1. Prepare equipment qualification protocol, execution of protocol and summary report
2. Prepare performance requalification protocol and execution of the protocol according to equipment requalification planner.
4. Issuance of documents.
5. Prepare initial document (e.g. SLIA and URS) and prepare or review qualification document such as IQ, OQ and PQ for new equipment
6. Ensure all equipment are in calibrated and validated state.
7. Ensure status of equipment is available and indicated clearly on the equipment.
8. Report to superior or Engineering/Instrumentation and Automation for any issue for the equipment.
9. Liaise with vendor and SCM for external calibration service and PM service to ensure activities are carried out within the stipulated time.
10. Ensure PM and cleaning of equipment are performed according to approved procedure.
11. Coordinate and communicate with vendor or EM personnel on the PM and Calibration activity.
12. Perform spore population assay for Biological Indicator received from vendor. Incubate and release Biological Indicator result sent by Production.
13. Send new lot received of biological indicator to third lab party for testing.
14. Coordinate with QCM Lab personnel for lab shut down activity, fumigation activity or any major maintenance work.
15. Record and update the test results according to approved procedure.
16. Preparation of SOP, EOP or format related to equipment and instrument in QCM.
17. Initiation of change management for SOP, EOP or format revision or protocol revision.
18. Performs vial inspection during Media Fills activity.
19. Initiate SAP Purchase Requisition (PR) and follow up on Purchase Order (PO) with SCM team for service related item (PM, Calibration, Laundry, etc.) and initiate GRN in the system in the absence of QCM SAP Team personnel or as when required.
20. Ensure all task given conducted according to cGMP guideline, EHS policy, Good Documentation Practice and Best Laboratory Practise.
21. Ensure the testing area in Quality Control Microbiology Laboratory is monitored for temperature, relative humidity (RH) and differential pressure and all the parameter are within the limit.
22. Conduct training on the procedures related to Quality Assurance, Specification, SOPs and EOPs.
23. Maintain the employee personnel record according to Good Documentation Practice (GDP)
24. Ensure all the related activities perform in Quality Control Microbiology Laboratory according to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Documentation Practice.
25. Review water sampling test reports and trending of both Production Drug Product (PDP) and Production Drug Substance (PDS).
26. Responsible for RQ activities of 02-19-DHS-01, 02-19-BOD-02, 02-19-BOD-03, 03-07-WII-02 and 02-19-DER-01 (but not limited to).Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 3 - 9 years

Biocon