Validation Specialist - Cambridge, United Kingdom - CK GROUP

CK GROUP
CK GROUP
Verified Company
Cambridge, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

CK Group are recruiting for a Validation Specialist on behalf of a growing Cell Therapy CDMO to be based at their site in Cambridge on a permanent basis.


About the Company:


Our client is based in state of the art facilities for multi-product GMP manufacturing, they are currently undergoing an extensive period of growth and development, and are expanding the QA team as part of this growth.

They have an established eQMS and LIMSsystem, and their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.

They are within easy commuting distance from Cambridge City Centre, and with excellent transport links to Central London.


About the Role:


The Validation Specialist will be responsible for leading validation, qualification and verification of manufacturing equipment, facilities and laboratory systems in accordance with GMP requirements.

The Validation Specialist will be required to author, execute and report validation activities within the framework of GMP and in compliance with the QMS requirements.


Your responsibilities will include:


  • Support implementation of a riskbased approach to the validation of systems to ensure compliance with GMP, and company quality documents and guidelines.
  • Preparing and maintaining validation plans, assisting with impact assessments, risk assessments and identifying validation requirements for equipment, facility and systems projects.
  • Assist in the authoring of User Requirement Specifications.
  • Adhere to the company Change Management System for all changes to existing or implementation of new systems.
  • Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the 'validated state'.
  • Supervise validation testing performed by vendors to ensure work is complete and accurate, critically review results of validation studies and work with vendors for issue resolution and validation deviation reporting
  • Undertake validation project execution in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved.
  • Present validation documentation to regulatory authorities during site inspections.

About You:

To be considered for this position you should have the following skills and experience:

  • Experience leading qualification/validation activities within the biopharmaceutical or related sectors (e.g. cleanrooms, lab equipment, monitoring systems)
  • Demonstrable experience of validating manufacturing/laboratory equipment, facilities and processes including the generation/execution of lifecycle documents.
  • A Degree (or equivalent) in a Science or related discipline Essential
  • A knowledge and understanding of how to implement the GAMP guidance.
  • Experience in interacting with regulatory authorities during inspections Desirable

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54880 in all correspondence.
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