Accountable to deliver an efficient global and compliant validation strategy for multi-site as well as for local projects / programs implementation of OT solutions.
Ensure that the validation strategy, roles & responsibilities between global and local functions and personnel are clear and understood to ensure compliance of all OT GMP systems and answer accurately to any questions from health authorities.
Maintain the validated status of OT solutions across all manufacturing sites.
Main responsibilities :
Maintain the validated status of global OT Systems and Applications with the system owner(s) and the local CSV experts.
Ensure that Computer System Validation related CSOPs are understoodand implemented for OT Systems and Applications. Any required changes to the existing validation approach for OT Systems and Applications must be carried out (i.
e. : updating existing documentation or adding new documents according to a change in the related CSOPs). Work with the authors of the CSOPs to ensure that any specific validation requirements covering the implementation and operation of OT Systems and Applications is considered.
Accountable to define the validation strategy for new global OT project implementations and upgrades, ensuring easy ongoing maintainability for routine changes or where changes are expected to be more frequent (i.
e. : splitting the validation documentation for each interface and for each custom-made user screen).
Responsible to create the global CSV documents templates to support new OT project implementations according to the validation strategy and provide support to local CSV experts whenever required during global project execution.
Ensure that the validation documentation and the structure of global OT Systems and Applications are well understood by the manufacturing sites, so they can be independent during health authority audits.
Enforce the use of electronic systems for testing (i.e. : RQM) and ensure similar testing structure among projects. Where applicable enforce and support the regression testing using automated testing tools.
Participate in the assessment of system reviews, deviations, CAPA, Changes, continuous improvement and troubleshooting related to Global OT Systems and Applications.
Establish and lead the process / framework to monitor compliance adherence of OT Systems and Applications both globally and locally with the sites.
Responsible to create and maintain through the entire lifecycle the list of GMP OT applications with their compliance condition
Guide and support sites during health authority inspection as required, e.g. describing the validation approaches across multiple sites, expert input into questions related to CSV, etc.
Required Experience & Competences :