- Contract Type
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 email@example.com
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