Title: Manager, Microbiology
Date:
May 9, 2025
Location:
Dadra - Quality Control
Company:
Sun Pharmaceutical Industries Ltd
Manager, Microbiology
Location: Dadra
Designation: Manager 2
Education: BSc / MSc in Microbiology
Experience: 10+ Years
- Maintain the microbiology laboratory as per regulatory requirements.
- Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples.
- Handling of microbiology related OOS/OOT, Deviation, Lab event.
- Prepare the response and closure of audit observations.
- Change control management for revision of SOP’s, Validation protocol.
- Ensure the availability of resources of microbiology laboratory.
- Ensure the microbiologist certification program of all microbiologist.
- Implementation of new projects for cost saving, compliance enhancement , work simplification.
- Having technical knowledge of following major test
- MLT of OSD products and MLT validation.
- Disinfectant efficacy test ( Disinfectant Validation)
- Maintenance of microbial cultures
- Maintenance of Microbiological media, Growth promotion test.
- Autoclave validation
- LAF, Biosafety cabinet, Incubators, pass box validation.
- Objectionability assessment of identified inhouse isolates.
- ALCOA++
- Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211
- Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment.
- Purified water system validation. Chemical and microbial analysis of water.
10. Audit experience for FDA, MHRA. ANVISA, TGA etc.
11. Handling of software following but not limited:
- SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software
12. Hands on experience of major instruments like:
- Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet.