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NPI Compliance Specialist

3 months ago

Sligo, Sligo, Ireland Cpl Full time

NPI Compliance Specialist (Biologics)

Responsibilities

  • To ensure new products transferred to the client are manufactured following applicable regulatory requirements and policies.
  • Responsible for maintaining the effectiveness of the integration of new products into the quality system.
  • 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.
  • Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.
  • Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
  • 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.
  • 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.
  • Support review and approval of new product related analytical Test Method Transfers and/or validation.
  • Support the management of new product related exception documentation, including the generation of corrective and preventative action to prevent reoccurrence.
  • Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
  • Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
  • Adheres to and supports all EHS & E standards, procedures and policies.

Requirements

  • A third level qualification in a science, quality or relevant discipline.
  • A minimum of three years experience in a quality role supporting new product introductions.
  • Strong knowledge of regulatory requirements is required
  • Regulatory, quality and New product introduction background .

Desirable

  • 2 Years' experience gained within an aseptic processing environment, ideally gained within a quality function

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