Job
Description
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.
