QC Validation Specialist

Are you ready to play a pivotal role in bringing cutting‑edge gene therapy products to life by ensuring the analytical methods behind them meet the highest global standards?

R&D Partners is seeking a Quality Control Validation Specialist to support the validation and transfer of analytical test methods for gene therapy products. This role ensures compliance with EU and FDA GMP standards while contributing to the development, implementation, and maintenance of quality control processes.

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

Responsibilities:

• Create and analyze validation protocols, data, and reports to ensure compliance.
• Ensure all test methods meet regulatory standards and are transferred to GMP labs.
• Write and maintain standard operating procedures (SOPs) for validated methods.
• Communicate progress and updates to stakeholders and maintain accurate records.
• Regularly assess analytical methods to ensure they are functioning as expected.
• Support the Quality Management System by managing documents and ensuring data integrity.
• Track and achieve personal goals and objectives within set timelines.
• Ensure all work complies with GMP, data integrity, and documentation standards.
• Complete assigned tasks such as addressing issues, CAPAs, and change controls in a timely manner.
• When needed, perform testing of gene therapy products to meet production schedules.

Key Skills and Requirements:

• Background in health sciences or a related field (degree or higher preferred).
• Experience in pharmaceutical or regulated industries, particularly in analytical method validation.
• Familiarity with techniques like qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction.
• Knowledge of ICH Q2R1 guidelines and proficiency in Microsoft Office tools.
• Strong problem-solving, organizational, and communication skills.
• Ability to work efficiently, prioritize tasks, and maintain professionalism under pressure.

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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