Validation Services

Tender description

This URS prospectively defines the requirements for the provision of Validation Management Services in the IBTS. The general activities to be carried out by this service within the IBTS will include, but will not be confined to: • To manage all operational Validation activities within the organisation • To continue to develop and implement a compliant Validation strategy for the IBTS; • To enhance and further establish the Validation Department within the IBTS; • To continue to develop and implement an efficient, compliant and cost-effective calibration and maintenance programme; • To report on-going performance of Validation activities to the Director of Quality and Compliance. • Be capable of delivering high level reporting to Executive and Senior Management. • Manage all facets of assigned Validation projects while maintaining strong communication with stakeholders on project status and assistance needed. • To contribute Validation expertise to other project activities where required. • To manage scheduling, planning and review of Validation activities for the Validation department, including on training and skills development; • To work closely with the Quality and Compliance Department and all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements. • Manage and maintain all relevant service, maintenance and calibration contracts.