Executive

3 days ago

Halol, India Sun Pharmaceutical Industries Ltd 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 machineries.
- Documentation work like New production introduction form, Scale-up reports, review of CMO BMR, sampling plan, PV protocol.
- Training to all operator and supervisor for any incident and investigation and SOP.
- 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 CMO.
- To ensure that the Packing operations or activities are carried out on timely.
- To ensure that the Stability charging of product are 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 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, MBMR.
- Accurate and timely reporting of various production activities showing performance and short coming against agreed /planned parameter to report.
- Any other responsibility assigned by department head after ensuring the relevant training status.

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