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Validation and Quality Assurance Consultant - Hamlyn Williams
Are you a Qualified Person (QP) with a strong background in GMP and aseptic processing? This is a fantastic opportunity to join a leading pharmaceutical organisation at the forefront of biologics manufacturing.
We are currently recruiting for a Qualified Person to support batch certification and release at a state-of-the-art manufacturing facility in Sligo.
This is a high-impact contract role, ensuring compliance with EU GMP guidelines and contributing to patient safety through effective quality oversight.
Key Responsibilities:
* Ensure compliance with Annex 16 and Directive 2001/83/EC, certifying batches for human use.
* Verify that products are manufactured in line with the Marketing Authorisation (MA), Product Specification File (PSF), andEU GMP.
* Make final disposition decisions on bulk products—release or reject—based on all available manufacturing and testing data.
* Act as a key QA contact supporting the site’s quality systems and batch review processes.
Requirements:
* MSc in Industrial Pharmaceutical Science (or equivalent QP-eligible qualification recognised by the HPRA).
* Minimum 4 years' industry experience in a GMP-compliant, FDA/EMEA-approved pharmaceutical environment.
* At least 2 years' experience in aseptic processing, preferably within a Quality function.
* Strong understanding of batch certification, GMP compliance, and regulatory expectations for QPs.
If you are interested in learning more, please apply with your CV or contact us directly for further details.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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