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 that processes and equipment meet validation and qualification standards according to relevant regulations.
Responsibilities:
* Prepare and maintain the site validation plan.
* Maintain and archive Validation/Qualification documentation.
* Collaborate with other departments to ensure validation project plans are understood and followed.
* Communicate and provide training on the required validation standard to staff and contractors.
* Review and approve validation, qualification protocols and reports.
* Provide supervision to project-related deviations.
* Assist generation of Process and Q/C Equipment Installation, and Operational and Performance Qualifications.
* Interface with external consultants and partners, suppliers and contractors to ensure successful process and equipment validation.
* Provide QA assistance to data integrity compliance activities across the site.
* Assist Regulatory Inspections and third-party audits.
* Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents.
Key Skills & Requirements:
* Bachelor's degree in Science or Engineering.
* Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
* Extensive experience providing QA technical support and oversight to validation and qualification activities.
* Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.
* Experience using risk assessment tools including Failure Mode and Effects Analysis (FMEA).
* Able to balance business needs with regulatory challenges.
* Proven ability to work successfully in an ambitious, deadline-driven environment handling multiple tasks simultaneously.