Skilled and dedicated in engineering? Looking for a new challenge in Validation? Proclinical is seeking a QC Validation Specialist which is your next perfect role!

This position will be required to lead the validation of test methods and ensure full compliance with EU and FDA GMP standards while contributing to the development of cutting-edge analytical techniques.

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

Responsibilities:

• Help develop and validate new and existing test methods for gene therapy products.
• Create and analyse protocols, reports, and data to support method transfer activities.
• Ensure all methods meet regulatory standards and maintain data integrity.
• Write and update standard operating procedures (SOPs) for validated methods.
• Communicate progress and updates on method transfers to stakeholders.
• Regularly review analytical methods to ensure they are functioning as expected.
• Support the maintenance of the Quality Management System and document control processes.
• Track and achieve personal goals and timelines effectively.
• Perform testing of gene therapy products when required, ensuring alignment with production schedules.

Key Skills and Requirements:

• Background in human health or sciences, with relevant qualifications.
• Experience in quality control or analytical method validation in a regulated industry.
• Familiarity with techniques such as qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction.
• Knowledge of ICH Q2 R1 guidelines and proficiency in Microsoft Office tools.
• Strong organizational and communication skills.

For more information, please contact Grant Van Schalkwyk.

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.

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