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Senior Recruitment Consultant at NIRAS Ireland.
QP - Quality Assurance Specialist
Sligo, Ireland
NIRAS Ireland are currently recruiting a QP - Quality Assurance Specialist within our clients 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 in compliance with laws in force in Member State where certification takes place, in accordance with requirements of Product Specification File (PSF)/Marketing Authorisation and with GMP for products manufactured at clients 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 client site are manufactured in accordance with relevant GMPs.
* The Quality Assurance Specialist / Qualified Person will be responsible for disposition of bulk product manufactured at site as acceptable for release or reject based on information available relating to manufacture and testing of product.
* Disposition bulk product as acceptable for release, or reject, to ensure patient safety based on information available relating to manufacture and testing of batch.
Experience and Qualification Requirements
* MSc in Industrial Pharmaceutical Science or similar course recognized by HPRA to permit Qualified Person (QP) status per Article 49 of Directive 2001/83/EC
* 5 years work experience gained within an FDA / EMA approved pharmaceutical environment.
* Will ideally have 2 Years’ experience gained within an Aseptic Processing Environment in a quality function- not essential but an advantage.
* Strong understanding/knowledge of full end-to-end requirements of a QP (not just batch release).
* Must have experience in participating in Audits.
* Ability and understanding to get fully involved in the full manufacturing process.
* Excellent attention to detail
* Strong influencing skills - ability to influence colleagues not reporting directly to the QP.
* Ideally hold 2 Years’ Aseptic Processing Environment experience gained within a quality function.
What to Do next
For a confidential discussion regarding this and our many other exciting opportunities with NIRAS Ireland, 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 design and delivery of process-driven and high end life science projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the advanced Process Manufacturing, Life Science, Food & Beverage sectors across Ireland and internationally. One of Europe's largest development consulting firms. NIRAS employs over 3000 permanent staff and has a pool of 25,000+ experts across our network. With 51 offices in 32 countries. A value-driven, multi-disciplinary engineering consultancy, NIRAS is fundamentally committed to sustainable progress and service delivery. At NIRAS you can grow! Come join us.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance, Manufacturing, and Consulting
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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