Senior Manager

3 weeks ago


Mumbai, Maharashtra, India Ipca Laboratories Limited Full time

Job Summary:

Ipca Laboratories Limited is seeking a Senior Manager - Technology Transfer to lead the planning and execution of scale-up and Exhibit batches of solid oral dosage forms for regulated markets.

About the Role:

The ideal candidate will have 15 to 20 years of experience in tech transfer activities and managing teams of scientists, documentation officers, and technicians.

Key Responsibilities:

  • Responsible for planning and execution of scale-up and Exhibit batches of solid oral dosage forms for regulated markets.
  • Responsible for on-time initiation of stability studies of Exhibit batches.
  • Manage and maintain technical service area (Pilot batch area).
  • Review documents relevant to scale-up and Exhibit batches execution and provide filing documents to RA.
  • Coordinate with cross-functional teams to meet aggressive timelines for regulatory submissions.
  • Review, approve, and implement change control proposals, deviations, and CAPA for scale-up and Exhibit batches.
  • Evaluate and respond to deficiencies of drug products by regulatory agencies.
  • Support production department for validation batches and troubleshooting of commercial batches.

Requirements:

  • 15 to 20 years of experience in tech transfer activities.
  • Experience of managing teams of 15 to 20 scientists, documentation officers, and technicians.

Working at Ipca Laboratories Limited:

Ipca Laboratories Limited is a leading pharmaceutical company committed to delivering high-quality products and services.


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