Product Introduction Specialist

22 hours ago


Sligo, Sligo, Ireland beBeeCompliance Full time €60,000 - €75,000
Job Title

A Compliance Specialist is needed to support the introduction of new products into our pharmaceutical facility in Ireland.

Responsibilities
  • To ensure compliance with regulatory requirements and policies during product manufacturing.
  • Maintain the integration of new products into our quality system.
  • Support product transfers from development to commercialization, collaborating closely with cross-functional teams to address quality concerns and mitigate potential risks.
  • Evaluate and approve vendors, manage technical agreements, and review analytical test method transfers.
  • Collaborate with QA, R&D, and other functional groups to maintain roles and responsibilities, identify quality issues, and provide input on quality concerns.
  • Coordinate site reviews of material specification documents, including in-process, BDS, drug product, raw material, and excipient specifications.
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 and a background in quality and new product introduction.
  • Experience gained within an aseptic processing environment, preferably within a quality function.
  • Strong interpersonal and decision-making skills, with experience leading projects.
  • A high level of attention to detail and mental concentration to ensure accuracy and total compliance with Quality procedures at all times.


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