Title:  Executive

Date:  Jan 22, 2023
Location:  Baska 2 Plant
Company:  Sun Pharma Medicare Ltd
  • 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, 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 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.
  • 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.

  • 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, 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 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.
  • 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.