Hobson Prior collaborates with a Biotech company seeking a Specialist in QA Validation.
The chosen individual will supervise the production and distribution of Gene Therapy medicinal products, ensuring processes and equipment meet validation and qualification standards as per relevant regulations.
Responsibilities:
1. Maintain and update the site validation plan.
2. Archive and manage Validation/Qualification documentation.
3. Collaborate with departments to ensure validation project plans are understood and followed.
4. Communicate and provide training on validation standards to staff and contractors.
5. Review and approve validation protocols and reports.
6. Provide supervision for deviations related to projects.
7. Assist in generating Process and Quality Control Equipment Installation, Operational, and Performance Qualifications.
8. Interface with external consultants, partners, suppliers, and contractors to ensure successful process and equipment validation.
9. Provide Quality Assistance for data integrity compliance activities across the site.
10. Support Regulatory Inspections and third-party audits.
11. E nsure work complies with GxP, Data Integrity, and Good Documentation Practice (GDP) and adheres to applicable quality documents.
Key Skills & Requirements:
1. Bachelor's Degree in Science or Engineering.
2. Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
3. Extensive experience providing QA technical support and oversight to validation and qualification activities.
4. Knowledge of cell culture-based manufacturing techniques and requirements for cellular and gene therapies.
5. Experience using risk assessment tools, including FMEA.
6. Ability to balance business needs with regulatory challenges.
7. Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.