Biologics NPI Compliance Specialist – Onsite

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 (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.