QA Specialist - NPI

PE Global is currently recruiting for NPI Compliance Specialist for a Client site in Sligo: This will be a 12-month initial contract role - 100% onsite NPI Compliance Specialist (Biologics) Top skills required:

1. Support of new product transfers to the site from development through to clinical and commercialisation
2. Support of vendor evaluation and approval, managing technical agreements
3. Support of review and approval of NPI related analytical test method transfers
4. Support of review and approval of NPI product transfers Must have previous experience working in NPI and understanding of the principles of start-up (product and/or process), aseptics, quality (QS and/or Quality Ops), analytical skills.

Responsibilities

• To ensure new products transferred to site 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

Interested candidates should submit an updated CV, marked for the attention of Audrey

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