Mahender Paul Sharma

WORK HISTORY

EDUCATION

ABOUT MAHENDER PAUL SHARMA

Overall, Planning, coordination, Execution of Microbiological functions and Daily work allotments. Ensuring compliance to all activities related to microbiological MLT method validation, Purified Water analysis, BET, Bioburden testing of finished goods, GPT of prepared and ready to use media, Culture Maintenance, Environment Monitoring, Trend Preparations, Media inventories and microbial Isolate Identifications. Ensuring the implementation and up gradation of standard operating as per new requirements/guidelines.Review/ Initiation of Change Controls related to microbiology lab w.r.t. recommendation of validation/qualification requirements.Carrying out investigations related to OOS/OOT, Deviation and market complaint. Ensure microbiology lab in ATR state and to provide laboratory operation leadership. Handling of customer Audits/Regulatory audits and preparation of regulatory/customer audit observation responses within defined timelines. Handling of QMS software’s: Track wise CQMS CCR/OOS/investigations/Lab events/CAPA/market complaints) LMS(Trainings)/EDMS(documentation) Preparation, review, execution of Equipment Qualification Protocols and Reports to ensuretimely completion of approved summary reports. Support to Aseptic processing manufacturing Plant for various validations & studies and timely submission of microbiological reports. Preparation of URS, Qualification (IQ, OQ, PQ) of Newly Procured laboratoryEquipment/instrument. Preparation, review, execution of products method validation (BET and Bio burden)Protocols and to ensure timely completion of approved summary reports. Imparting training to people on microbiological aseptic process control.Hands on experience of instrumentsVitek2,LAF,Biosafety cabinet,incubators, Autoclaves, conductivity meter, pH meter, TOC Analyzer,Air sampler, non viable particle counter,air sampler, colony counter and Microscope etc Execution and Qualification of classified area/Analyst qualification. Qualification and calibration of various laboratory instruments. Ensuring adherence to accuracy, adequacy, authenticity of analytical data. Trending of analytical data of environment monitoring /Purified water/Raw water/drinking water.Ensures key performance indicators(KPI,s) are in place,relevant and continually evaluated.