Execution of technology transfer to Sun/CMO  Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance.

Handling & Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO.

Investigation for product trouble shooting

To ensure that the Packing operations or activities are carried out on timely.

To monitor & prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing & dehydrogenation, CIP/SIP System, PLCs, instruments etc. Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches & their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments’ i.e.  Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.