QC ValidationSpecilaist

Are you driven to uphold the highest standards in pharmaceutical quality control? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide.

R&D Partners is seeking a QC Validation Specialist to support the development, validation, and transfer of analytical test methods for gene therapy products. This role ensures compliance with EU and FDA GMP standards while maintaining data integrity and quality control processes. You will play a key role in ensuring methods are validated, transferred, and implemented effectively within GMP labs.

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

Responsibilities:

• Develop and validate new and existing test methods for gene therapy products.
• Create protocols, analyze data, and generate reports to support method validation and 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 to stakeholders and maintain organized documentation.
• Assess analytical methods regularly to ensure proper application and functionality.
• Support the Quality Management System by managing documents and ensuring compliance.
• Track and achieve individual goals and objectives within set timelines.
• Perform testing of gene therapy products as needed, ensuring alignment with production schedules.

Key Skills and Requirements:

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

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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