Hobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer and supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant regulations.

Please note that to be considered for this role you must have the right to work in this location.

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 Q/A 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:

• BSC in Science / Engineering.
• Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
• Extensive experience with 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 in using risk assessment tools including FMEA.
• Ability to balance needs of the business with the needs of the Regulatory challenges.
• Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.

For more information, please contact Billy O'Brien.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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