Agm - technology transfer (formulation)

3 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 c GMP, SOP’s and all other regulatory agency requirements, where applicable.

  • 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: ...


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    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: ...

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