**Job Title:** Manager / Sr.Manager Micro Lead **Job Grade:** G10 / G9B **Function:** Global API Business **Sub-function:** **Managers Job Title:** **Skip Level Managers 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 equipments 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 We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.