15h Left: QA Validation Specialist
6 days ago
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
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