Back to Job Search

NPI Compliance Specialist (Biologics)

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 23099

Our client based in Sligo are looking to hire a on an NPI Compliance Specialist (Biologics) initial 12 month fixed term contract

 

Responsibilities

  • To ensure new products transferred are manufactured following applicable regulatory requirements and policies.
  • Responsible for maintaining the effectiveness of the integration of new products into the NPI 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.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717