Officer

Job Description

1. Candidate should have good knowledge about all microbiological related activity, Environmental monitoring of classified areas, Water testing Bioburden BET and Sterility.
2. Environmental monitoring of all classified areas of Drug product manufacturing.
3. Media Preparation required for Utility and area monitoring.
4. To execute Validation/Qualification/Re-qualification as per protocol.
5. Sub culturing, serial dilution of standard cultures and GPT and Identification of isolate.
6. To execute IQ/OQ/PQ of the new equipment installed in the Microbiology Section.
7. Sampling, Testing of Water samples
8. To perform Population Determination of Biological Indicators.
9. Operation of Daily pH, Balance Calibration, Autoclave, DHS, Incubators, Air Samplers and particle counter.
10. To report any Deviations/ Out of Specifications results and Safety risks to the supervisor as and when observed.
11. Candidate should have good experience in the BET testing by using Gel clot and KTA method
12. To perform Qualification of Equipment, Autoclave, DHS, Incubator, KTA, etc.
13. The candidate should be familiar with cGMP requirements, Change Control, Deviations, Out of Specifications, Sample management, Stability Management and investigation tools.
14. To perform Compressed air sampling and analysis
15. To ensure cGMP compliance and maintain the laboratory in audit ready condition.
16. The candidate should be familiar with SAP system.

Work Experience

Relevant Experience of 1 to 4 years

Education

Competencies