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Quality Systems and Validation Manager

Quality Systems and Validation Manager

Posted 20 September by Jobs in Science
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The Client

Our Client ensures that innovative science and technology contribute to the defence and security of the UK. They are looking to recruit a Quality Systems and Validation Manager.

Duties/Responsibilities:

  • Author/Review/Approve validation deliverables.
  • Design and manage Validation Master Plan strategies
  • Provide CSV oversight to IT programmes assuring compliance in-line with but not limited to: FDA, MHRA, GxP and company standards.
  • Ensure that standards regarding Computer Systems Validation are implemented and adhered to.
  • Work with business users and IT staff to identify and scope validation related processes.
  • Identify compliance risks (with respect to Pharmaceutical industry regulations impacting computer systems) and proactively work with the business and IS to address these.
  • Provide leadership to ensure that computer systems validation activities are implemented consistently across applicable programmes
  • Coaching, Guidance and Assurance to project teams on computer systems validation deliverables.
  • Influence and enforce Good Documentation Practice standards
  • Work around change controls
  • Attend governance, progress and review meetings when requested by the project team(s).

Qualifications/Experience

  • Academic degree (or higher) in Biomedical/Life Sciences, Chemistry, Quality Management or similar experience
  • A Member of Professional Body
  • Strong personal competencies/skills as well as personal drive, and organisational skills.
  • You should also be able to demonstrate excellent verbal and written communication.
  • Experience and knowledge of working in a Good Manufacturing Practice environment, Good Laboratory Practice and Good Clinical Practice.
  • Be able to communicate clearly and effectively to people of all levels within the company, customers and external suppliers.
  • An ability to influence scientific and technical staff of GXP requirements Good IT Skills - proficient in MS Office Word, Excel, PowerPoint and Outlook is also required.
  • If deemed inside IR35 - Please note that the client has determined that the off-payroll working rules will apply to this assignment and where a worker elects to provide their services through an intermediary (such as a personal services company) then income tax and primary national insurance contributions will be deducted at source from any payments made to the intermediary.
  • If deemed outside IR35 - Please note that the client has determined that the off-payroll working rules will not apply to this assignment.

Required skills

  • Management Skills
  • Validation
  • Computer Systems Validation
  • SC clearance
  • Pharmaceutical Background

Reference: 36159872

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