Are you an experienced QA professional seeking a pivotal role in a dynamic and innovative environment?
Join a leading team specialising in Gene Therapy medicinal products, where your expertise in Quality Assurance, Validation, and Qualification will contribute directly to groundbreaking advancements in healthcare.
As a QA Validation Specialist, you will play a key role in providing technical support and oversight for the validation and qualification of manufacturing facilities and QC laboratories.
Working closely with cross-functional teams, you will ensure compliance with Irish, EU, and FDA regulations while maintaining the highest standards of quality.
Key Responsibilities: Develop and maintain the site validation master plan.
Oversee the qualification of processes and equipment, ensuring adherence to cGMP and regulatory requirements.
Provide training and guidance on validation standards to internal teams and contractors.
Review and approve validation protocols, reports, and deviations.
Collaborate with engineering, operations, QC, and external partners for seamless execution of validation projects.
Support regulatory inspections and third-party audits.
Author and maintain SOPs, policies, and work instructions for validation activities.
About You: You are a results-driven professional with: A BSc in Science or Engineering.
A strong Quality Assurance background in sterile manufacturing within pharmaceutical or biotech environments.
Extensive knowledge of GxP compliance and validation requirements, including EU Annex 15, EU Annex 11, and CFR Part 11.
Familiarity with cell culture-based manufacturing and gene therapy processes.
Exceptional organisational, interpersonal, and communication skills.
This is an exciting opportunity to contribute to a cutting-edge facility dedicated to transforming patient outcomes.
Be part of a collaborative team in an ambitious, deadline-driven environment where your skills and experience will be valued and rewarded.
How to Apply: If you are passionate about quality, innovation, and making a real difference in the field of Gene Therapy, we want to hear from you.
Apply today and take the next step in your career!
Skills: Quality Assurance Validation Qualification Benefits: Negotiable Healthcare Bonus Pension