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Innovations Specialist - NPI Support

Haleon · Jamshoro

New
🇬🇧 English
FDA/ICH guidelines GMP

Job description

About the role

Haleon is looking for an Innovations Specialist to manage and provide frontline support for all New Product Introduction (NPI) initiatives. The role covers execution of trials at the shop floor and in the laboratory, close coordination with cross-functional teams as part of the project team during technical transfer at site, and process troubleshooting to give technical support to production.

Key responsibilities

  • Support cross-functional teams in product transfers, launches, line extensions and technology transfer.
  • Contribute to Site Impact Assessments by collecting data and evaluating site capabilities, costs, resources and timelines.
  • Help prepare, run and monitor project plans, timelines, action trackers and risk registers.
  • Prepare and run laboratory, pilot, engineering and validation trial batches to assess product and process feasibility.
  • Support product transfer, scale-up, registration, validation and launch with relevant stakeholders.
  • Maintain technical documentation for product development, technology transfer and regulatory submissions.
  • Assist in product costing and resolve costing queries with Finance, Production and Quality.
  • Apply knowledge of APIs, excipients, formulations and packaging materials to support development and manufacturing.
  • Support procurement in technical evaluation and sourcing of raw materials and packaging.
  • Help prepare CTD documents and other information for regulatory submissions.
  • Support investigations of complaints, OOE, OOS and deviations to find root causes.
  • Ensure compliance with GMP, quality and other applicable policies and guidelines.

Required profile

  • B.Pharmacy, Chemistry or equivalent BS degree in a scientific or engineering discipline.
  • In-depth knowledge of FDA/ICH guidelines, BP and USP, and the regulations and standards routinely used in the pharmaceutical industry.

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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Haleon

Jamshoro