CSV Manager

Location
Wiltshire
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
CA9504
Contract Type
Permanent

This role reports into the Validation Programme Manager and is responsible for the Computer Systems validation activities. The purpose of the role is:

  • To lead and manage the compliance status and validation activities of computerised systems and associated equipment in accordance with current regulatory requirements.
  • To minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the equipment and product’s life cycle.
  • To develop a validation strategy vision and strategic plan which delivers compliant systems that are cost effective with long term sustainable components.
  • To develop individual validation strategyies for large complex high value computer systems.
  • To lead, motivate and manage a team of Validation Specialists responsible for the validation of computerized systems and general equipment to deliver validation projects on time and in line with regulatory requirements.
  • To be the site management Leader on Computer System Validation activities communicating regulatory issues and business risks to senior management together with recommended actions.
  • To be an industry expert on Computer System Validation strategy.
  • To develop and manage KPIs for CSV and to manage the scheduling of all validation activities within the business.

This position would suit someone with 5+ years' CSV experience and experience in a biopharmaceutical manufacturing environment. You will need to be an experienced people manager and familiar and competant as an SME in regulatory inspections.

 

For more information and to arrange a confidential discussion about your career options, please email your CV to charlotte.allen@hobsonprior.com

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