Officer – QC Microbiology

1. Ensures that work is compliant with GLP & GMP.
2. Be responsible for work area cleanliness.
3. All other duties as assigned.
4. Responsible for execution of qualification and validation of laboratory equipment, instruments.
5. Responsible for sampling of water samples as per the SOP
6. Responsible for analysis of starting materials, packaging, materials, intermediate, bulk and finished products analysis using appropriate aseptic techniques.
7. Responsible for preparation of specifications, sampling instructions, test methods and other Quality Control – Microbiology procedures.
8. Responsible for environmental monitoring programs within the lab and the manufacturing area clean rooms (production and warehouse) as per the SOP.
9. Responsible for culture conservation (growth promotion).
10. Ensure that the laboratory instruments/ equipment is always within the calibrated/ validated state.
11. Responsible for method validation, verification, and testing of method transfer samples.
12. Responsible for preparation investigation report OOS, OOT and Incident management.
13. Responsible for continuous improvement in the laboratory testing compliance.
14. Responsible for testing of stability sample within window period.
15. Responsible for preparation of all type of Microbiology related trends reports.
16. Responsible for Good Documentation practices during reporting and documentation.
17. Ensure the inventory is in place to ensure a smooth operation of the laboratory and does not impact the manufacturing operations.
18. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.
19. Shall be responsible for quality control – Microbiology operational excellence.
20. Shall be accountable for timely completion of SOP, GLP and CGMP training.
21. Supports value streams in identifying and implementing corrective actions and increasing knowledge of good hygiene and microbial control practices.
22. Shall be responsible for writing SOP’s or guidelines for the use of analytical equipment and to describe Laboratory working practices
23. Should have a keen eye for detail and is readily able to identify procedural or GMP errors within the laboratory and in the production floor during environmental monitoring
24. Required to write procedures and / or reports for Laboratory working practices.
25. Working with plant personnel to ensure that relevant processes and facilities also are microbiologically acceptable.

5 to 8 years of Pharmaceutical Quality Control experience.

University Degree in Microbiology/ Biotechnology/ Life Sciences

Microbiology