Assistant Manager

To perform the Technology transfer of Product from R&D to Site. Receiving activities and QMS related activities at the manufacturing plant. To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare / review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol / report, stability study protocol / report, Process validation protocol and Report for the scale up, exhibit and validation batches. To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant. Ensure cGMP and Regulatory compliance.