Assistant Manager

To lead the technology receiving activities and QMS related activities at manufacturing plant. To lead technology-receiving activities to receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes developing and maintaining key SOPs, manufacturing records to support compliance with quality management and regulatory submissions. To lead alternate vendor batch execution, process improvement, change in batch size, troubleshooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To coordinate the development of the manufacturing process with the R&D by keeping in mind scale-up issues, process specifications, and operating procedures for new products, new equipment, and technologies for successful product receiving. To involve in finalizing 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 review and approve 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, OOS, Market complaints, CAPA identification and QMS related activities at plant. To provide technical support for CMC section of ANDA submissions or other regulatory agency documents prior to forwarding to the Regulatory Affairs for inclusion in the supplement submission.