1. Should be able to lead the team of about 20+ microbiologists for working for Sterile product testing, environmental monitoring and purified water.
2. To establish systems/Procedures and ensure implementations in different functions of microbiology, review of test conducted, SOPs, Specifications and standard testing procedures.
3. Evaluation and closure of Deviations, change controls, New document initiation form and its closure and
4. Support to investigation related to microbiology laboratory ( events , out of specification etc.)
5. To review of qualifications and validations protocols and reports and respective raw data related to Microbiology.
6. To review the Analytical data of intermediate and finished product before release
7. To ensure that the changes of specifications /Standard testing procedures are properly evaluated, documented, approved and closed properly.
8. To ensure the stability samples are tested as per the frequency.
9. Ensure that the self-inspection audit is done as per schedule.
10. Ensure the timely validation of the qualification of the other applicable departments
11. External audit coordination and compliance
12. Ensure the compliance of the established procedures
13. To perform the method validations
14. To support the queries related to Microbiology
15. Ensure the qualification/re qualification of the microbiology instruments