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Quality assurance specialist/qp

Sligo
QCS Staffing
Quality assurance specialist
Posted: 5 January
Offer description

Quality Assurance Specialist/QP - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Quality Assurance Specialist/QP to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.What You'll DoComply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice 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.Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force.To ensure that products manufactured by the client are manufactured in accordance with the relevant GMPs.Responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.What you'll need:Third level qualification in a science discipline with extensive experience in the pharmaceutical industry.MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/ECExtensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.Extensive experience gained within an aseptic processing environment, ideally gained within a quality function.If this role is of interest, please apply now

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