Sr. Manager

1 day ago

Ahmednagar Maharashtra, India Sun Pharmaceutical Industries Full time

Job Title Manager Sr Manager - Micro Lead Job Grade G10 G9B Function Global API Business Sub-function Manager s Job Title Skip Level Manager s Title Function Head Title Location Ahmednagar No of Direct Reports if any Areas of Responsibility To plan review and monitor overall activities in Microbiology and lead the department Co-ordination with other departments for priorities and provide the timely support testing to avoid delay due to analysis Review of all departmental related documents and review results in LIMS system in microbiology section Ensure all documents are complete in time To review the lysate sensitivity test Bacterial endotoxin test of WFI and API products To check method validation of bacterial endotoxin test and microbial quality of products To procure receipt storage maintenance its use and reconciliation of biological indicator media reagents standard cultures and bioball etc To ensure and check calibration and Operation of TOC analyzer Execute breakdown If any in consultation with vender To ensure environmental monitoring activities performed as per schedule and to check the environmental monitoring reports To review qualification Calibration of all instruments in microbiology laboratory as per SOP Schedule To participate in investigation and to review of deviations OOS OOT OOC Lab Event review of SOPs as per revision date in micro section online in track wise system To highlight observations rejection failure quality related concern in time and contribute in troubleshooting To ensure and review all logbooks and registers are maintained on line and available at designated place Preparation and review of GMP documents related to activities To review and ensure fumigation activity and its verification as per SOP Guidelines To prepare review trends for water and environment monitoring Summary report of water and environment monitoring Responsible to follow online good documentation practices for data recording and monitoring To ensure and review validation of autoclave Dry heat sterilizer DHS Incubators Laminar Air flow HVAC To ensure and review preparation of reagents and volumetric solution and its standardization as per specification SOP To ensure and review inventory and stock record of media reagents culture lysate CSE LRW To ensure to follow the GLP as per current practice in the laboratory To ensure safety and use of personnel protective equipment s during day to day activities Responsible for carrying out any other responsibilities assign from time to time orally or in writing by Quality head however related training imparted to concerns To support for review and compliance activity in quality function and to support for any time readiness as well as enhancement of system and practices To Coordinate with corporate functions with respect to microbiology activity Travel Estimate Job Requirements Educational Qualification M Sc Microbiology Specific Certification Skills Experience 15 to 18 Yrs

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