NPI Compliance Specialist

2 weeks ago

Galway, Galway, Ireland Quanta Consultancy Services Ltd Full time

NPI Compliance Specialist - Sligo, Ireland - 12 Months Contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for an NPI Compliance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.

Essential duties and responsibilities for this role include, but are not limited to, the following:

  1. To ensure new products transferred to our client are manufactured following applicable regulatory requirements and policies.
  2. Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
  3. NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
  4. Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.
  5. Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
  6. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
  7. Coordination of site review of new product related material specification documents including but not limited to in process, BDS, Drug Product, raw material and excipient specifications.

Desirable Experience:

  1. A third level qualification in a science, quality or relevant discipline.
  2. A minimum of three years' experience in a quality role supporting new product introductions.
  3. Strong knowledge of regulatory requirements is required.
  4. Regulatory, quality and New product introduction background.
  5. Extensive experience gained within an aseptic processing environment, ideally gained within a quality function.

If this role is of interest, please apply now

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