Pankaj Chaudhari

1.Execution and review of HEPA filter integrity test in aseptic area. 2.Execution and review of smoke study test in aseptic area. 3..Execution and review of area qualification study of aseptic area. 4.Preparations of aseptic media fill protocol and involved in planning, execution of aseptic media fills batches. 5..Review and execution of Qualification of AHU ,aseptic Area Qualification and Water system Qualification.

1.Communication with cross functional team such as production, Engineering, microbiology and quality control to run validation activities smoothly. 2.Preparation and review of the media fill summary reports. 3.Execution and review of Gowning qualifications of persons involved in aseptic area operations. 4.Investigation of Out of Specification results of Viable and Non-viable monitoring in Aseptic area. 5.Investigation of media fill failure activity.

1.BMR review, In process checks. 2.Execution and review of area recovery test in aseptic area. 3.Execution and review of smoke study test in aseptic area. 4.Execution and review of area qualification study of aseptic area. 5..Preparations of aseptic media fill protocol and involved in planning, execution of aseptic media fills batches. 6 .Preparation, execution, compilation and approval of process validation protocols and reports. 7.Standard Operating procedure preparation and approval of the same.

1.Media Preparation: 2.Environment Monitoring of Aseptic and clean areas 3.Microbial limit test 4.sterility testing and BET of water 5.Investigation of OOS of water analysis, Environment monitoring. 6.Master culture maintenance and culture dilution for routine use. 7.Review of Process simulations in Aseptic area. (Media Fill). Review of Environmental reports of Media fill, MLT reports, Water analysis reports, Sterility reports.

Microbiology

1.Microbiology 2.chemistry.