SYNGENE Sr.Executive Microbial analysis of
BET samples
Microbial analysis of BET samples.
2. Responsible for conducting analysis and recording
observation in real time abiding by the company's data integrity policy.
3. To comply with the requirements to all relevant QA/QC and
other relevant SOP's
4. Review of analytical documents generated by another
microbiologist.
5. Reading of plates for the analysis performed by other
analysts and reporting of results.
6. Initiation of OOS and OOT.
7. Preparation of Finished Product, In-process and raw
material specifications, Method of Analysis protocol for different validations.
8. Preparation of SOP/SOP-E/GP and training for the same.
9. Preparation of protocol for clean room/area
qualification/requalification of the clean room/area and water generation and
distribution systems.
10. Attend the queries related to Microbiology during
audits.
11. Maintain the Microbiological data as per requirement of
Quality System.
12. Maintaining the training records as per requirement of
Quality System.
13. Responsible to comply with the current procedures on
good documentation practices.
14. Follow the required EHSS policies and Good hygiene
practice.
15. Initiate/investigate the QMS related activities like
Deviation, OOS/OOT, CAPA and taking approval from QA abide by company's Data
Integrity policy.
16. Escalate any discrepancy in analysis noted during review
to the team lead in real time.
17. To review the results reported by approved
contract-testing laboratory against In-house protocols /Specification.
18. Responsible for coordinating with QA for all
investigations.
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