Senior Executive

3 days ago


Halol Gujarat, India Sun Pharmaceutical Industries Full time

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



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