5+

B.Pharm, M.Pharm, B.E, B.Tech. with 6 to 10 years of experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.

This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory.

Will be responsible for managing Discovery, Development projects end to end. Adept at managing project milestones, budget and stakeholders. Should have excellent communication skills. Must be a good negotiator and must have hands-on knowledge in MS Project, MS Excel.

1 to 4 years in Quality Control, Microbiology, Molebio, Quality Assurance Experience Biosimilars, vaccines, Sterile industry is required.

Having Experience in Environmental Monitoring, Water Testing, In process Sampling, Analysis of Bulk Water, Finished and API by MLT, Bioburden, BET, Sterility, PET and Antibiotic Assay.

To handle all kind of lab instruments and experience to perform AMV and Documentation EM Monitoring, Water testing. Trend preparation, Microbial Testing, SOP and Protocol and other micro related activity

B.Pharm / M.Pharm; To perform equipment qualification, utility qualification activity with proper documentations. To perform Computer system validation. To investigate deviation, change request, OOS, market complaint etc.

Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Track status and progress of regulatory documentation.

Lab Exposure, Analytical Method Validation. Review of Specification. Method of Analysis Protocol Handing of 00S and 00T. Investigation and Lab event. Review & Approval of QC Documents. Knowledge of Qualification and Validation related Activities. Audit Trail Review etc