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QA CSV Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Haverhill, Suffolk
  • Sector: Quality & Compliance
  • Date posted: 27/06/2018
  • Job reference: J387223A

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QA CSV Specialist

In this position you will be reporting to the Quality Project and Validation Manager, the Computer Systems Validation Specialist will coordinate CSV related activity on site.

This position is key in the current transition of the site, to take part to the new projects: deployments of tools on site and new equipment and new activities. It is a transversal role, with the possibility to take part of the development of other people of the team.

Key responsibilities:

  • Provide validation expertise in the lifecycle management of all aspects of computer system validation (CSV), qualification, data integrity and regulatory compliance activities;
  • Works to maintain and manage quality systems regarding GAMP and cGMP for the site;
  • Supports or performs internal and third-party audits and inspections to assure compliance with regulations;
  • Provide support and guidance to site projects and operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV;
  • Review and approve validation deliverables and provide guidance in their creation;
  • Maintain local computer system inventory;
  • Drives continuous improvement;
  • Manage scheduling of Periodic and Security Reviews and ensuring adherence to these schedules;
  • Keeps up to date on regulations and legislation with respect to CSV and evaluates the effect of new or changed law and practices on current operations.

Essential requirements:

  • Degree or equivalent in a science, engineering, computing or pharmaceutical related subject area;
  • Demonstrated knowledge of working within a Quality Management System and cGMP;
  • Proven ability to lead project teams or host quality audits;
  • Understanding of current industry requirements of cGMP, Annex 11, GAMP, 21 CFR Part 11;
  • Experience of working on GAMP related projects for multiple aspects of IT and/or process control systems;
  • Current regulatory knowledge in the field of computer systems validation.

For more information on this or other potential opportunities please contact Kathryn on 003531 6455250 for a confidential discussion

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