Product Steward

  • Cork
  • Fastnet – The Talent Group

Summary:

Our client, a global pharmaceutical is currently looking for a Product Steward to join their team on a permanent basis in their Cork site.

The Product Steward owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving. The product steward will ensure seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). The role will provide second line technical/scientific process support.

Your responsibilities

  • Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date
  • Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
  • Ensure inspection readiness for all process related aspects of assigned products.
  • Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
  • Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific QRA).
  • Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
  • Collaborate with OPEX for product / process improvements.
  • Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
  • Requirements:

  • BSc in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
  • 8+ years' experience in process support within the Pharmaceutical industry.
  • Experience of data handling and applied statistics is a must.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).
  • Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

    Fastnet - The Talent Group
    'Not Just Placers.........Partners'

    The Life Science Specialists