Quality Assurance Specialist

3 weeks ago

Sligo, Sligo, Ireland Quanta Consultancy Services Ltd Full time
Quality Assurance Specialist - Ireland, Sligo - 12 Month Contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for aQuality Assurance Specialist 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.

Essential duties and responsibilities for this role include, but are not limited to, the following:

- Comply 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 in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products
- The Quality Assurance Specialist / Qualified Person (QP) is 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.
- To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.

Desirable Experience:

- 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/EC
- Requires extensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
- Strong 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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