Validation Specialist

1 month ago


Dartford, Kent, United Kingdom Catalent Full time
Job Title: Validation Associate

Catalent is seeking a highly skilled Validation Associate to join our team at our Dartford site. As a key member of our Quality Assurance team, you will be responsible for ensuring the validation of equipment, facilities, utilities, and laboratory computer systems.

Key Responsibilities:
  • Develop and maintain the site Validation Master Plan and validate documents, including schedules, plans, protocols, reports, and exceptions.
  • Coordinate and organize equipment validations, such as new lab instrumentation, operations equipment, and temperature mapping of warehouse.
  • Participate in Validation History Reviews to ensure compliance with regulatory requirements.
  • Review Process and Analytical Development reports and assess their suitability for validation.
  • Provide technical guidance on process deviations and equipment performance.
  • Write or amend Batch Manufacturing Records as required.
  • 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 knowledge of regulations and legislation.
  • Experience in managing multiple projects and executing validation protocols.
  • Experience working in a cGMP environment.
About Catalent:

Catalent is a global leader in the development and delivery of pharmaceuticals, biopharmaceuticals, and consumer health products. We are committed to advancing new medicines from early development to clinical trials and to the market. Join us in making a difference in the lives of patients around the world.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.



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