Key Requirements: Initiation, planning, execution, monitoring of Scale-up/ Optimisation /Exhibit and Validation batches for new and site transfer projects. Preparation and review of documents like Scale-up study Protocol and Reports. Preparation of MFR, MPR, PVP, PVR, Sampling protocol, Stability protocol, hold time study protocol, RM/FP specifications etc. as per regulatory market requirements. Conducting gap analysis, risk assessment before start of technology transfer activities for site readiness. Coordinate with cross-functional teams for smooth technology transfer. Trouble shooting and optimization of process parameters to minimize risk during technology transfer. Monitoring of Stability studies and Data interpretation.Desired qualifications: M.PharmacyDesired Skills: Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail. Hands on experience in technology transfer of products for regulated markets. Knowledge on cGMP, Change control(s), deviation(s), Incident(s) etc. Knowledge on Regulatory requirements for global markets. Trouble shooting and Root cause analysis skills.Job Type: Full-timeSalary: ?20,000.00 - ?25,000.00 per monthJadwal:
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