Posted:4 days ago|
Platform:
Work from Office
Full Time
Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists
ACG
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