Quality Assurance Specialist - NPI Compliance (Biologics)
Sligo, County Sligo, Ireland · Full Time
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- Experience
- 3+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 2 weeks ago
- Work mode
- In office
- Education
- Any graduate
- Resume
- Required to apply
Where you'll work
Job description
Overview
EFOR Group seeks a knowledgeable NPI Compliance Specialist with expertise in quality assurance to support a biologics manufacturing site based in Sligo, Ireland. This role centers on overseeing the integration of new products into established quality systems while ensuring adherence to international regulatory requirements.
Key Responsibilities
- Manage incorporation of new products into quality management systems abiding by global standards such as cGMP, HPRA, and FDA.
- Facilitate the transfer of new products from development phases to full commercialization collaborating closely with cross-departmental teams to address quality issues and mitigate potential risks.
- Lead the vendor qualification process, administer technical agreements, and oversee the transfer and validation of analytical testing methods.
- Prepare, update, and control essential documentation related to product transfers and quality deliverables.
- Act as a subject matter expert during internal and external quality audits.
- Encourage a culture focused on accuracy and continuous enhancement of processes and procedures.
Candidate Profile
- Holds a tertiary qualification in science, quality assurance, or related disciplines.
- Possesses at least 3 years of experience in a quality assurance role supporting introduction of new products.
- Demonstrates thorough knowledge of regulatory frameworks and quality standards within pharmaceutical or biologics industries.
- Exhibits strong project management, sound decision-making abilities, and excellent interpersonal communication skills.
- Experience in aseptic processing or in a quality role dealing with aseptic environments is a distinct advantage.
Additional Information
Join a global network of over 3,200 professionals across 18 countries, collaborating to make real contributions in the Life Sciences sector. This full-time position is based on-site in Sligo, offering an opportunity to be part of a dynamic and impactful team committed to technical excellence.
Location: Sligo, Ireland (Onsite)
Employment Type: Full-time