We are #hiring for #Microbiologist; 9 -10 years of experience.
Location: Pithampur, Madhya Pradesh
API Plant
Responsibilities:
1. Plan and coordinate environmental monitoring activities during batch manufacturing, filling, and media fill operations in sterile facilities.
2. Manage Out-of-Action/Out-of-Alert-Limits (OOAC/OOAL), incidents, deviations, and non-conformances in the microbiology laboratory.
3. Perform and oversee a range of tests including MLT, EM, Antibiotic Assay, Sterility, GPT, Sub Culturing, BET, and DET tests.
4. Conduct validation studies including method validation, media fill activities, hold time studies, water and area qualifications, and autoclave validations.
5. Oversee the qualification of new instruments and equipment in the Quality Control Microbiology Laboratory.
6. Lead the Green Land project for new facility installation.
7. Manage consumable items qualification including bio balls, biological indicators, gloves, and IPA 70% qualification.
8. Oversee GLP section operations and ensure compliance.
9. Conduct equipment swab tests and drain swab analysis in FFS facilities.
10. Conduct water testing, compressed gas, and nitrogen sampling in sterile and non-sterile facilities.
Additional Responsibilities:
1. Lead GLP team and manage work distribution.
2. Review GLP and analytical documents.
3. Install and execute instrument qualifications.
4. Prepare specifications and SOPs.
5. Ensure compliance with GLP and GDP.
6. Prepare and review validation protocols and reports.
7. Conduct calibration and water testing.
8. Qualify areas and monitor microbial activity.
9. Prepare media and conduct sterility testing.
10. Handle quality performance indicators.
11. Investigate laboratory incidents.
12. Maintain documentation and training records.
13. Manage stock of microbiology materials.
14. Verify instrument logbooks and calibration.
15. Conduct trainings and ensure GLP compliance.
Instrument Handling:
Calibration of incubators, BOD incubators, colony counters, autoclaves, LAF, UV lights, antibiotic zone readers, micro pipettes, pH meters, analytical balances, digital microscopes, foggers, and air samplers.
Interested candidate can share their profile at poonam.lahire@thinqcro.com
