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Validation Manager

3 months ago

Great Yarmouth, Norfolk, United Kingdom Atom Recruitment Ltd. Full time
Our Client is a very successful pharmaceutical manufacturing company. They are now seeking a
Validation M anager. This position is a full-time permanent role and will be based in Great Yarmouth.

Job Purpose

  • An exciting new opportunity has arisen for a Validation Manager, to join the QA Department
  • The role will be responsible for managing the validation programme for the Group and will report to the Group Quality Manager.
  • Travel will be required to support validation activities at all UK sites

Key Areas of Responsibility

  • Reviewing and approving all validation plans, protocols and reports as written by the validation personnel.
  • Executing cleaning validation protocols
  • 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

Qualifications / Experience

  • Solid 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
Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.