Qc Validation Specialist

4 weeks ago

Shannon, Ireland Hobson Prior Full time

Overview
Technical Operations & R&D Recruiter | Life Sciences Talent Partner Across Europe
Proclinical is seeking a QC Validation Specialist to lead the validation of test methods and ensure compliance with EU and FDA GMP standards, 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.
Application Information
For more information, please contact Grant Van Schalkwyk.
If you are interested in applying to this opportunity, please click "Apply" or visit the "Contact Us" page to speak with one of our specialists.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions globally.
Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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