Officer/Sr. Officer/Executive/Sr. Executive(Quality Control) Details
JOB RESPONSIBILITY
Position: Officer/Sr. Officer/Executive/Sr. Executive (freshers can also apply)
Experience: Having experience of 2- 8 years in Parental plant.
1. Responsible for Daily sampling and analysis of in-process and water samples as per procedure.
2. Responsible for Preparation and pouring of media plate.
3. To perform BET (Bacterial Endotoxin Test) test and Micro assay.
4. To perform Sterility Test, Bioburden and MLT (Microbial Limit Test) or water and product.
5. To Perform Growth Promotion / Inhibitory / Indicative Property Test of Media.
6. To report results of analysis in raw data sheet issued.
7. Entry and maintain all micro related logbooks.
8. To Follow the QMS (Quality Management System) system (Out of Specification, Deviation, Incident)
9. To participates in validation activity.
10. Observation and review of media fill container.
11. To perform environmental monitoring in clean room as per standard operating procedure.
12. To run the autoclave cycles and unload the loads as per SOP (Standard operation procedure).
13. To monitor incubator condition daily and record, to take print out and verify.
14. To maintain the GLP (Good laboratory practices) and follow GDP (Good documentation practices) in the laboratory.
15. To run washing and drying machine.
16. To raise Out of Specification if noticed.
17. Responsible to perform analysis of Analytical method Validation, Analytical method Transfer, reconstitute Solution stability, additional analytical test required as per party quarry reply.
18. Responsible for preparation Analytical method validation protocol, raw data, report.
19. Responsible for review of Analytical method validation protocol, raw data, report.
20. Responsible for preparation excel sheet preparation of analytical method validation, method transfer, Reconstitute Solution Stability study.
21. Responsible for planning of method validation activity. Requirement of sample, standard, reference standard, column, instrument provide to the analyst.
22. Responsible for training providing to the analyst for analytical method validation and method transfer SOPs (Standard operating procedures).
23. Responsible to control and maintain records like protocols, raw data, and report of method validation, method transfer and reconstitute solution stability. Analysis records, usage log books and status labels during day-to-day Analysis of validation.
24. Any other Responsibility assigned by HOD (Head of Department).
25. To assist HOD (Head of Department) for the preparation of regulatory inspection.