Quality Assurance Specialist

7 days ago


Brighton, Brighton and Hove, United Kingdom DNA Life Sciences Full time
About the Role

We are seeking a highly skilled Validation Manager to lead our quality assurance efforts and ensure compliance with EU GMP guidelines and other relevant regulations. As a key member of our team, you will be responsible for developing and implementing the Site Validation Master Plan (SVMP) and validation policies.

Key Responsibilities
  • Lead the Validation Team: Oversee the validation team and track departmental KPIs to ensure the team has the capacity and capability to deliver the SVMP schedule.
  • Ensure Compliance: Ensure all systems comply with regulations and industry standards, including Annex 11, Annex 15, GAMP 5, and ICH Q8/9/10.
  • Develop and Implement Policies: Develop and implement validation policies and procedures to ensure consistency and efficiency in our quality assurance processes.
  • Support Inspections and Audits: Represent the site during inspections and audits, and provide technical expertise and framework for validation documentation.
  • Manage Change Controls: Manage change controls, non-conformances, CAPAs, and effectiveness checks to ensure continuous improvement and best practices within the function.
  • Drive Continuous Improvement: Drive continuous improvement and best practices within the function, and promote company values and Good Manufacturing Practice principles.
Requirements
  • Education: Degree in science or engineering.
  • Experience: Experience in biotechnology/pharmaceutical industries, specifically in GMP validation, and experience in aseptic/sterile GMP manufacturing.
  • Skills: Strong leadership, communication, problem-solving skills, and a proactive approach.


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