Job Title:Qualified Person (QP) - BiologicsJob Type:12-month ContractRate:up to €90 per hourLocation:Sligo, IrelandOverview:We are currently seeking an experiencedQualified Person (QP)to join aleading Biologics siteinSligo. This role is central to ensuring that all products manufactured on site meetEU and international regulatory standardsand are safe forpatient use.Key Responsibilities:Ensure compliance with EudraLex Volume 4, Annex 16, and Article 47 of Directive 2001/83/EC .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) .Review manufacturing and testing records to make informed decisions on the release or rejection of bulk products .Ensure the site's manufacturing processes comply with current GMP requirements at all times.Support cross-functional teams and continuous improvement projects as required.Provide technical guidance and collaborate effectively with internal teams and external suppliers .Act as a key decision-maker within the framework of the site's quality systems and regulatory standards .Maintain awareness of safety protocols and report any EHS (Environment, Health, and Safety) incidents or near misses in line with company procedures.Requirements:Third-level degree in a scientific discipline.MSc in Industrial Pharmaceutical Science or similar recognised by the HPRA .Must be QP qualified and experience in releasing products in Ireland.At least 5 years' industry experience within an FDA and EMEA-compliant pharmaceutical manufacturing environment.4+ years experience with strong understanding/knowledge of the full end-to-end requirements of a QP (not just batch release).Minimum 2 years' experience in aseptic processing, ideally within a quality function .Experience in leading as an SME in audits .Proven ability to quickly develop expertise in products and processes .Strong interpersonal, communication, and decision-making skills .Ability to work independently and take ownership of responsibilities with minimal supervision.Only candidates with a valid work visa for Ireland or an EU passport will be considered.To discuss this role in more detail, contactCornéat orfor a confidential discussion.