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CSV Manager

Job title: CSV Manager
Contract Type: Permanent
Location: Lake, England
Industry:
Salary: £63000 per annum
Reference: BH-93723
Contact Name: Ellen Twomey
Phone Number: 01
Job Published: 17 days ago

Job Description

Computer System Validation Manager

Salisbury

£63,000 Plus other Benefits

 

My client manufactures biological medicinal products for commercial and clinical release. This role within the Validation team is necessary to manage the regulatory cGMP compliance of computerised and software systems, ensuring that they are appropriately qualified and fit for operational use. The role will ensure that the commercial risks associated with disaster recovery and data life cycle compatibility are addressed for each computer system guaranteeing long term availability of business critical systems and data. The mitigation of risk in this respect starts at the design phase as source code access, firm-ware capability; disaster recovery and historical data access need to be addressed early on.

This role will provide  strategic management comprising of a vision, mission and strategic plans which meets the business need with respect to compliance management and business risk mitigation within the scope of the  validation of computerised systems.

JOB SUMMARY

  • 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 strategy’s 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.
MAIN DUTIES AND RESPONSIBILITIES

  • To provide strategic leadership and management of computer system validation comprising of a vision, mission and strategic plan which meets the business need with respect to compliance management and business risk mitigation related to the validation of computerized systems.
  • Responsible for the generation of individual validation strategies for large complex computerised systems to ensure that these systems are sustainable and to ensure that all compliance and business risks are assessed and mitigated.
  • To be the site management Lead 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.
  • Responsible for the management of validation and on-going requalification strategy for all regulated computer systems on site.
  • Lead and manage a team of validation specialists to provide computer systems validation services and expertise for GxP regulated activities across the site.
  • Lead and manage a team of Validation Specialists to deliver general equipment validation projects on time and in line with regulatory requirements.
  • Manage and deliver specific Validation Projects for computerised equipment according to business priorities.
  • Manage the commissioning and qualification of new computerised equipment to be used for GxP activities.
  • Write, review and approve validation documentation to ensure that it meets internal and regulatory requirements.
  • Manage the scheduling and reporting of computerised system validation.
  • Manage the assigned budget within authority level.
  • Undertake continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
  • In line with overall responsibilities, perform additional tasks assigned by the line manager.
  • Undertake all work in accordance with Safety Practice and site Quality Policies.
 

Please get in touch if this sounds like the right role and challenge for you!