Desired Skills: npi,compliance qa
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:
- Support of new product transfers to the site from development through to clinical and commercialisation
- Support of vendor evaluation and approval, managing technical agreements
- Support of review and approval of NPI related analytical test method transfers
- 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
audrey.mccarthy@peglobal.net or 00353 21 4297900
Contract 
Sligo, County Sligo, Ireland 
42112079 
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