A pivotal role awaits an experienced QA professional in a dynamic and innovative environment, specializing in Gene Therapy medicinal products. Your expertise in Quality Assurance, Validation, and Qualification will contribute directly to groundbreaking advancements in healthcare as a QA Validation Specialist.
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.
Benefits
* Negotiable Healthcare Bonus
* Pension
Required Skills
* Quality Assurance
* Validation
* Qualification