QA Compliance Specialist

PE Global (UK); Sligo; On-site; EUR 50,000 - 70,000; Full time

Job summary

PE Global (UK) is currently seeking an NPI Compliance Specialist for a 12-month contract role based in Sligo. This position involves supporting new product transfers and liaising with cross-functional teams to ensure compliance with regulatory requirements.

The ideal candidate will have a third level qualification in a relevant discipline and at least three years of experience in quality roles related to new product introductions. Strong knowledge of regulatory requirements is crucial.

Qualifications

• Minimum of three years experience in a quality role supporting new product introductions.
• Strong knowledge of regulatory requirements.
• Background in regulatory, quality and new product introduction.

Responsibilities

• Ensure new products are manufactured following regulatory requirements.
• Maintain effectiveness of integration into NPI quality system.
• Liaise with cross-functional teams on quality concerns.
• Manage technical agreements from initiation to storage.
• Coordinate reviews of new product specification documents.
• Generate product transfer documentation before stage gate review.

Skills

Support of new product transfers

Vendor evaluation and approval

Understanding of NPI principles

Analytical skills

Education

Third level qualification in science or quality

Job description

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 Aisling

[e-mail] or 00353 21 4297900