QC Validation Specialist

Ensuring analytical excellence at the forefront of gene therapy innovation.

R&D Partners is recruiting a Quality Control Validation Specialist to support a leading biotechnology organisation based in the Republic of Ireland. This role will contribute to the development, qualification, and implementation of analytical assays used to support advanced biologics and related manufacturing materials. The successful candidate will bring strong hands‑on HPLC expertise, along with a thorough understanding of regulatory expectations for assay qualification and lifecycle management within EU and FDA GMP environments.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead the design, authorship, execution, and review of analytical method validation studies, including protocol and report writing.
• Develop and validate both established and novel analytical methods for current and emerging gene therapy products.
• Perform data analysis, interpretation, and technical reporting to support method transfer and validation activities in compliance with regulatory expectations.
• Ensure all analytical methods are validated and transferred into QC GMP laboratories in accordance with ICH, EU, FDA, and data integrity requirements.
• Maintain ownership of assigned GMP documentation, including CAPAs, Change Controls, BMRs, and audit/inspection actions, ensuring timely and accurate completion.

Key Skills and Requirements:

• Strong expertise in HPLC (non-negotiable).
• Direct experience designing validation studies with a solid understanding of regulations governing analytical method validation.
• Familiarity with GMP documentation processes and regulatory compliance standards (ICH, EU, FDA).
• Proven ability to manage multiple priorities and deliver results within deadlines.

For more information, please contact Jessica Taylor.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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