Product Introduction Specialist

1 day ago

Sligo, Sligo, Ireland beBeeCompliance Full time €60,000 - €80,000
Job Title:

NPI Compliance Specialist

Job Description:

This is an exciting opportunity to join a leading pharmaceutical company in Ireland as an NPI Compliance Specialist. Located on the picturesque west coast of Ireland, our state-of-the-art facility is looking for a highly skilled professional to support the introduction of new products into our quality system.

Responsibilities:
  • Ensure new products are manufactured in accordance with applicable regulatory requirements and policies.
  • Maintain the effectiveness of the integration of new products into the NPI quality system.
  • Support new product transfers from development through to commercialization, collaborating closely with local and external cross-functional teams.
  • Coordinate vendor evaluation and approval, managing technical agreements from initiation to storage.
  • Collaborate with CMC QA, R&D, S&T, clients, and other functional groups to maintain roles and responsibilities, identify potential quality issues, and provide input on quality concerns.
  • Review and approve new product related analytical Test Method Transfers and/or validation.
  • Support review and approval of new product related exception documentation.
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.
  • Regulatory, quality, and New Product Introduction background.
  • Experience gained within an aseptic processing environment, ideally gained within a quality function.
  • High level of attention to detail and mental concentration to ensure accuracy and total compliance with Quality procedures at all times.
Benefits:

This role offers a challenging and rewarding career opportunity in a dynamic and fast-paced environment. As a key member of our team, you will have the opportunity to work with experienced professionals and contribute to the success of our business.

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