Validation Manager - Cambridge, United Kingdom - Cpl Life Sciences

Cpl Life Sciences
Cpl Life Sciences
Verified Company
Cambridge, United Kingdom

4 hours ago

Tom O´Connor

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Tom O´Connor

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Description
Validation Managers I have a very exciting opportunity for you.

An exciting new opportunity has arisen for a Validation Manager, to join our clients QA Department. The role will be responsible for managing the validation programme and will report to the Group Quality Manager. Travel will be required to support validationactivities.

Key duties and responsibilities will include:

  • Reviewing and approving all validation plans, protocols and reports as written by the validation personnel.
  • Executing cleaning validation protocols at Great Yarmouth and Kempston sites.
  • Managing projects and existing installations for temperature mapping / monitoring across sites. Providing data as required to key QA staff for temperature monitoring activities.
  • Raising and managing change controls for assigned projects.
  • Preparing, controlling, reviewing, and approving Quality documentation to align with QMS.
  • Maintaining awareness of upcoming regulatory environment.
  • Assisting other departments involved in validation activities including validation of equipment, processes, and the preparation of associated documentation.
  • Maintenance of the validation register for all sites.
  • Participation in specific improvement projects as required.
  • Liaising with the Computer System Validation team to ensure such aspects are covered during the execution of protocols.

Key Attributes/Skills:

  • Several years relevant quality experience in a pharmaceutical GxP environment.
  • Degree or equivalent in appropriate scientific discipline.
  • Experience of writing protocols, reports and executing Equipment & Facilities Validations, Cleaning Validations and Process Validations. Understanding of GAMP requirements for computer systems.
  • Clear understanding of; GMP, or any other GxP area, regulatory and accreditation systems, quality management, NC/CAPA, & Change Controls.
  • Knowledge of legal framework concerning pharmaceutical manufacture i.e. Eudralex, ICH guidelines, medical device legislation.
  • Excellent interpersonal skills to be able to liaise effectively at all levels.
  • Excellent attention to detail and documentation skills.
  • Ability to plan, organise and manage multiple projects.
  • Emotional resilience with the ability to work under pressure with a cando attitude.
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