"• 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, current 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."