Qualified Person (Biologics)

Description

• Review manufacturing and testing records to make informed decisions on the release or rejection of bulk products.
• Provide technical guidance and collaborate effectively with internal teams and external suppliers.
• Maintain awareness of safety protocols and report any EHS (Environment, Health, and Safety) incidents or near misses in line with company procedures.
• Support cross-functional teams and continuous improvement projects as required.
• Act as a key decision-maker within the framework of the site’s quality systems and regulatory standards.
• Ensure compliance with EudraLex Volume 4, Annex 16, and Article 47 of Directive 2001/83/EC.
• Ensure the site’s manufacturing processes comply with current GMP requirements at all times.
• Certify that each batch is manufactured and checked in line with local regulatory laws, the Product Specification File (PSF), Marketing Authorisation (MA), and Good Manufacturing Practice (GMP).

Requirements

Only candidates with a valid work visa for Ireland or an EU passport will be considered.

• At least 5 years’ industry experience within an FDA and EMEA-compliant pharmaceutical manufacturing environment.
• Minimum 2 years’ experience in aseptic processing, ideally within a quality function.
• Ability to work independently and take ownership of responsibilities with minimal supervision.
• MSc in Industrial Pharmaceutical Science or similar recognised by the HPRA.
• 4+ years experience with strong understanding/knowledge of the full end-to-end requirements of a QP (not just batch release).
• Must be QP qualified and experience in releasing products in Ireland.
• Third-level degree in a scientific discipline.
• Proven ability to quickly develop expertise in products and processes.
• Strong interpersonal, communication, and decision-making skills.
• Experience in leading as an SME in audits.

Benefits

Rate: up to €90 per hour

Training + Development

Interview process

Visa Sponsorship

Security clearance