Company: Strides Pharma Science Limited Department: R&D/ Corporate Location: Bangalore Designation: Group Leader (Technical Documentation Lead) Reports to: DGM Experience: 15 to 18 Years Education: M-Pharm Roles and Responsibility: Evaluation of process suitability for New/Site transfer product and strategizing the implementation plan upon confirming its suitability, Evaluation of Analytical data and analytical development Lead a team & coordinate between FD, QA, RAD, ASD, QC, SCM, Finance & manufacturing for execution of Exhibit batches, validation batches of site transfer / tech transfer, provide documentation assistance, give technical inputs with in applicable regulatory guidelines with the objective of ensuring efficient and timely transfer of technology from development to commercialization Implementation of Pharmacopeial Updates and Source Change Document. Managing master data operations within the LIMS and SAP system. Developing, Optimizing, Validating, Verifying and Method transfer of analytical methods. Ensuring discipline in TrackWise by monitoring pending tasks and facilitating the closure of quality events. Ensuring adherence to regulations and maintaining the completeness of relevant logbooks or registers. Conducting on-the-job training sessions on departmental SOPs to maintain compliance.
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