Senior Officer

4 months ago


Mumbai, India SUN PHARMA Full time
Execution of technology transfer to CMO/Site transfer, Scale-up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials, and machinery. Documentation work like New production introduction form, Scale-up reports, review of CMO BMR, sampling plan, PV protocol, URS preparation, 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 Troubleshooting batches for data comparison and route cause Investigation at CMO. To ensure that the Packing operations or activities are carried out on a timely. To ensure that the Stability charging of product is done 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. To prepare the Scale-up report, get evaluated and signed by an authorized person prior to going to Exhibit batches & submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering), and warehouse for the smooth running of Scale-up, Exhibit, and Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR. Accurate and timely reporting of various production activities showing performance and shortcomings against agreed /planned parameters to report.

Any other responsibility assigned by the department head after ensuring the relevant training status.


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