Computer Systems Validation specialist

Job type:
Real Staffing
flag_no United Kingdom
project ID:

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This is an amazing opportunity for a Computer Systems Validation specialist to join a successful and growing pharmaceutical team in the South East. The CSV will work to manage and execute validation activities with the cGMP compliance of computerized and software systems, ensuring that they are appropriately qualified and fit for operational use.

Salary: £33,000

Main responsibilities will be to:
  • Schedule validation and requalification activities for GMP facilities for the Facilities Validation Department.
  • Deliver specific Validation Projects according to the business priorities, including work scheduling and supervision of junior members of staff and contractors.
  • Write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities
  • Providing a reliable service to our internal customers to ensure that timescales are met and work is carried out to meet expectations.
  • Maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.
  • Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts

  • Comfortable working alone or within the matrix management system.
  • 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.

The position is very important as the post holder will be responsible for the scheduling of equipment and utilities requalification's to meet production deadlines. The post holder will be responsible for ensuring that the appropriate risk based validation activities meet the required regulatory expectations. Using their validation and leadership knowledge, skills and experience, the post holder will deliver specific projects and managing on-going revalidation requirements in accordance with current business objectives.

The successful candidate will be highly motivated, well organized and have been educated to BTEC National Certificate or higher and have substantial validation or equivalent experience within a GxP based working environment. They will have substantial experience in scheduling activities (ideally using Excel) to meet tight deadlines.

To apply for this role please email your CV