Job Description

• 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 shootingTo 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.