"• 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."
