AGM - Technology Transfer (Formulation)

4 weeks ago

mumbai, India Ipca Laboratories Limited Full time

Position:

AGM / DGM Technical Services


Qualification:

  • B.Pharma / M.Pharma


Experience:

  • 15 to 20 years experience in tech transfer activities of solid oral dosage forms for regulated market.
  • Experience of managing team of 15 to 20 scientists, documentation officers and technicians.


Job Location:

Kandivali, Mumbai


Job Description:

  • Responsible for planning and execution of scale-up and Exhibit batches of solid oral dosage forms for regulated market (US, EU, ROW and Canada etc).
  • Responsible for on time initiation of stability studies of exhibit batches.
  • To manage and maintain technical service area (Pilot batch area).
  • To review all documents relevant to scale-up and Exhibit batches execution like BMR, BPR, Protocols, scale up report, exhibit batches report and to provide filing documents to RA.
  • To co-ordinate with cross functional team like site manufacturing team (Production, QA and QC), R&D, RA, PDC, Supply Chain etc. to meet aggressive timeline for regulatory submission to meet business priorities.
  • To review, approve and effective implementation of change control proposal, deviation/Incident and CAPA for scale up and exhibit batches.
  • To evaluate and respond to deficiency of drug product by regulatory agencies.
  • Support production department for validation batches and trouble shooting of commercial batches.
  • Perform job responsibilities in compliance with cGMP, SOP’s and all other regulatory agency requirements, where applicable.

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