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.
Work both independently and as part of intra, inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
Regular reporting in Envision. To maintain the desired call average per month and frequency of calls to be done as expected with respect to Dual Ranking of Customers. Call objectives should be managed to give focus on various Products as agreed.
Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
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.
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.