Executive

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• 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.
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• Documentation work like New production introduction form, Scale-up reports, review of CMO BMR, sampling plan, PV protocol.
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• Training to all operator and supervisor for any incident and investigation and SOP.
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• To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality.
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• Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance.
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• Handling & Support of Trouble shooting batches for data comparison and route cause Investigation at CMO.
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• To ensure that the Packing operations or activities are carried out on timely.
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• To ensure that the Stability charging of product are done on timely
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• 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.
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• To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches & their submitted to QA.
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• Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality.
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• To review validation protocol, SOP and other cGMP Documents.
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• 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.
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• To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, MBMR.
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• Accurate and timely reporting of various production activities showing performance and short coming against agreed /planned parameter to report.
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• Any other responsibility assigned by department head after ensuring the relevant training status.
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M.Sc. / B. Pharma