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We are expanding our operations in Ireland and are currently looking for a Qualified Person (QP) to join our growing team. This is an exciting opportunity to play a key role in ensuring the quality and compliance of medicinal products in line with EU and global standards.
Key Responsibilities: As a Qualified Person , you will:
- Certify medicinal products in accordance with the product’s marketing authorisation, EU Directives, and relevant guidelines including Annex 16 and Annex 13 (for Investigational Medicinal Products).
- Provide expert guidance on critical and major quality and compliance matters.
- Lead quality initiatives across projects involving processes, products, and regulatory compliance.
- Oversee the quality management system, including procedures, release documentation, CAPAs, deviations, change controls, and quality agreements.
- Ensure all manufacturing, packaging, and related documentation is completed and approved by authorised personnel.
- Maintain independence in all quality-related decision-making.
- Support investigations and help resolve discrepancies effectively.
- Assist with audits, including client Health Authority inspections, internal audits, and supplier audits.
- Contribute to continuous improvement initiatives to enhance GMP compliance.
- Collaborate with cross-functional teams to provide quality-related consultation.
- Stay current with pharmaceutical legislation and industry best practices.
- Support the Quality / Compliance / Regulatory (QCR) business area lead in achieving strategic objectives and key results (OKRs).
- A third-level qualification in a science-related discipline.
- Eligibility and proven ability to act as a Qualified Person within the EC/EEA.
- 3–5 years of experience in a QP role.
- Strong communication skills, both written and verbal, with a collaborative and team-oriented mindset.
- Extensive experience in pharmaceutical quality systems.
- In-depth knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution, along with global GMP/GDP regulatory requirements.
- Audit experience is a plus.
- Excellent task management skills with the ability to prioritise and meet tight deadlines.
The NRL Group connect global companies with the right people to bring engineering projects to life. Supporting contracting companies with energy transition plans and working with our clients to create a cleaner, greener future.
We welcome applications from every walk of life and are committed to diversity within the industries we support, as a certified Inclusive Recruiter and Armed Forces friendly employer. You can ensure you stay safe when job searching online by visiting the JobsAware website.