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.
• Audit experience for FDA, MHRA. ANVISA, TGA etc.
• 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
• Hands on experience of major instruments like:
• Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet.