Validation Associate

3 weeks ago


Dartford, Kent, United Kingdom Catalent Full time
About the Role

Catalent is seeking a highly skilled Validation Associate to join our team at our Dartford site. As a key member of the QA team, you will be responsible for the full scope of Pharmaceutical Validation processes, including equipment, facilities, utilities, and laboratory computer systems validation.

Key Responsibilities
  • Develop and maintain the site Validation Master Plan and validate documents, including schedules, plans, protocols, reports, and exceptions.
  • Organize and coordinate equipment validations, such as new lab instrumentation, operations equipment, and temperature mapping of warehouse.
  • Participate in Validation History Reviews to ensure validation practices are in compliance with regulatory requirements.
  • Review Process and Analytical Development reports and other supporting documentation to assess suitability for validation and review performance of products.
  • Provide technical guidance in assessment of process deviations related to equipment performance and impact on product quality.
  • Write or amend Batch Manufacturing Records as required for existing products.
  • Manage a Quality Management system, including training, SOPs, internal audits, and document archiving.
Requirements
  • Graduate in Pharmaceutical Sciences or equivalent experience.
  • Experience in leading validation in a cGxP environment, with strong working knowledge of regulations and legislation relating to cGMP.
  • Experience of managing multiple projects and executing validation protocols.
  • Experience of working in a cGMP environment.
About Catalent

Catalent is a global drug development and delivery leader, helping to bring over 7,000 life-saving and life-enhancing products to patients around the world. We are committed to a culture of continuous improvement and people development, ensuring everyone at the site can grow and thrive.


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