GM or Executive - Technology Transfer

Job Description

Job Location: Dholka, Ahmedabad, Gujarat. Experience required: Minimum 6 years JOB DESCRIPTION : • To lead the technology receiving activities and QMS related activities at manufacturing plant. • To lead technology-receiving activities: 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, trouble shooting 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 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. • 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. Principal task and responsibilities: • Ensure cGMP and Regulatory compliance. • Ensure productivity of Manpower and Machines. • To cross check the online documents periodically to ensure the good document practice. • To rectify any activity which is making adverse effect on productivity or quality, in consultation with QA Department. • To ensure discipline from co-workers and get systematic work to improve quality. • To conduct CFT meeting to resolve day to day issues. • To ensure closure of change control note, deviation and give guidance to ensure that it is complete in time. Interested candidate can share resumes on disha.bhalani@cadilapharma.com