QP - Quality Assurance Specialist
Sligo, Ireland
Position Opportunity:
NIRAS Ireland is currently recruiting a QP - Quality Assurance Specialist within our client's Quality Assurance Department at their advanced Biologics facility based in the beautiful North West of Ireland. This is a 12-month contract, with the selected candidate reporting directly to the Quality Operations Lead.
Role
* Qualified Person responsible for ensuring each individual batch manufactured and checked complies with laws in force in the Member State where certification takes place, in accordance with the Product Specification File (PSF)/Marketing Authorization and GMP for products manufactured at the client's Biologics site in Sligo.
Responsibilities:
* Ensure compliance with EudraLex Volume 4 EU Guidelines GMP for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
* Ensure products manufactured at the client site are produced in accordance with relevant GMPs.
* Dispositon of bulk product as acceptable for release or reject based on manufacturing and testing information, ensuring patient safety.
Experience and Qualification Requirements
* MSc in Industrial Pharmaceutical Science or a similar course recognized by HPRA to permit Qualified Person (QP) status per Article 49 of Directive 2001/83/EC.
* At least 5 years of work experience in an FDA/EMA-approved pharmaceutical environment.
* Ideally, 2 years’ experience in an Aseptic Processing Environment within a quality function (not essential but advantageous).
* Strong understanding of full end-to-end requirements of a QP, not just batch release.
* Experience participating in audits.
* Ability to fully engage in the manufacturing process.
* Strong decision-making skills.
* Excellent attention to detail.
* Strong influencing skills to collaborate with colleagues not reporting directly to the QP.
Next Steps
For a confidential discussion regarding this opportunity, please contact Philip Cahill at 00353 482 2270 / 00353 87 997 9941 or email your CV to phic@niras.com.
Who We Are:
NIRAS Ireland specializes in designing and delivering process-driven, high-end life science projects. We provide project management, engineering design, and managed services to the advanced process manufacturing, life sciences, food, and beverage sectors across Ireland and internationally. As one of Europe's largest development consulting firms, NIRAS employs over 3,000 staff with a network of 25,000+ experts across 51 offices in 32 countries. We are committed to sustainable progress and service excellence. Join us and grow your career!
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