Npi Compliance Specialist (Biologics)

Our client based in Sligo is looking to hire an NPI Compliance Specialist (Biologics) for an initial 12-month fixed term contract.
Responsibilities Ensure new products transferred are manufactured following applicable regulatory requirements and policies.Maintain the effectiveness of the integration of new products into the NPI quality system.Support new product transfers to the site from development through to commercialization, liaising 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.Review and approve 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 quality compliance, and provide input on quality concerns.Coordinate site review of new product related material specification documents including but not limited to in process, BDS, Drug Product, raw material, and excipient specifications.Manage new product related exception documentation, including the generation of corrective and preventative actions to prevent reoccurrence.Generate product transfer documentation to attest to the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.Interface with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.Adhere to and support 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 within a quality function.For more information and a confidential discussion on the role, please contact Michelle Mc Inerney. ****** 091 706717

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