Qualified Person

Description

• Offer guidance to suppliers to maintain compliant and efficient relationships.
• Provide technical leadership and collaborate with cross-functional teams, supporting cost improvement projects and quality initiatives.
• Review and disposition bulk product as acceptable for release or reject, ensuring patient safety based on manufacturing and testing information.
• Ensure compliance with EHS policies, reporting incidents and supporting a culture of EHS excellence.
• Oversee batch release and certification processes for sterile biologic medicinal products
• Certify that each batch is manufactured and checked in compliance with applicable laws, Product Specification File, Marketing Authorisation, and GMP.
• Act autonomously in day-to-day quality decisions, escalating major issues as appropriate, and maintain close contact with all relevant personnel.
• Maintain up-to-date knowledge of products and processes to effectively assess and address quality issues.

Requirements

Arcadis DPS Engineering are a seeking a QP (Qualified Person) for a Pharmaceutical assignment located in Sligo. This is initially a 12-month contract.

• Third-level qualification in a science discipline with at least 5 years’ experience in the pharmaceutical industry.
• Strong cognitive and interpersonal skills, with the ability to quickly learn new products and processes and provide expert assessment of quality issues.
• At least 2 years’ experience in an aseptic processing environment, ideally within a quality function.
• Minimum 5 years of industrial experience in an FDA and EMEA approved pharmaceutical environment.
• MSc Degree recognized by Regulatory Authority for QP status.

Benefits

At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally.

By joining us, you’ll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.

Training + Development

Interview process

Visa Sponsorship

Security clearance