Quality Assurance Specialist / Qualified Person (QP)
Quality Assurance Specialist / Qualified Person (QP)
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Title: Quality Assurance Specialist / Qualified Person (QP)
Job Type: 12-month Contract
Location: Sligo, Ireland - 100% on-site
Ref Code: DES-1080
Eligibility: Must hold a valid work visa for Ireland or an EU passport
Overview:
A leading pharmaceutical manufacturing site in Sligo is seeking an experienced Quality Assurance Specialist / Qualified Person (QP) to join their team on a 12-month contract.
This role is crucial in ensuring that all products released from the site meet both EU and international standards - and are safe for patient use.
Key Responsibilities:
* Certify product batches in accordance with EudraLex Volume 4, Annex 16, and Article 47 of Directive 2001/83/EC
* Ensure compliance with the Product Specification File (PSF), Marketing Authorisation (MA), and GMP
* Review batch records and make decisions regarding release or rejection
* Maintain oversight of GMP compliance in all manufacturing processes
* Act as a decision-maker within the site’s quality and regulatory frameworks
* Contribute to site projects and continuous improvement initiatives
* Provide technical input across departments and liaise with external suppliers
* Adhere to safety protocols and report any EHS incidents
What We're Looking For:
* Degree in a scientific discipline
* MSc in Industrial Pharmaceutical Science (or equivalent QP-eligible qualification)
* 5+ years in pharmaceutical manufacturing (FDA/EMEA-compliant environment)
* Minimum 2 years’ experience in aseptic processing, ideally in a QA/QP capacity
* Excellent communication and decision-making skills
* Strong initiative and ability to work independently
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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