Validation Engineer Section head

Job Purpose

• Managing computer system validation activities for any CSV system testing related to new and existing systems in site, and improve CSV performance and site capabilities to comply with GSK requirements

Key Accountabilities/Responsibilities:

• Manage CSV department resources to cover all CSV testing for existing and new systems in site
• Managing the coordination process of the Computer System Validation activities with both value streams and Engineering departments
• Asses and Manage systems that have risks associated with the systems that will require testing/replacement more than the scripted schedule and assessing the existing controls and putting leverage points
• Lead the CSV work activities, planning, and execution associated with new projects and delivery of new systems into the site
• Responsible to ensure that security requirements for site systems is implemented and in use for both value streams and utilities systems
• Ensure that all CSV LSOP's, protocols and CSV master plan are in place, updated and ready for local or external audit
• Responsible to ensure that any completed CSV documents or CAPA actions are reviewed and ready for being audited
• Ensure deployment of effective L1 self inspection runs versus L1 plan
• Attend or delegate Engineering and CSV tiers board on regular basis
• Responsible to deliver Validation review testing reports for all validated systems as per Validation Review plan
• Ensure that CSV testing execution plan, CAPA's, CCR's and risk actions are adhered to set plan and all related KPI's are updated and according to plan timeline
• Responsible to deliver and execute all CSV corrective and preventive actions (CAPA's) generated from systems testing as per timeline
• Avail and create full training material to be official for any CSV Engineers
• Attend all governance meeting related to CSV activities such as quality council, RMCB,…etc., on regular basis
• Assist and give regular training for CSV role for all stakeholders department to raise CSV capability in the site
• Training of new CSV Engineers while maintaining the time line through time management for both plants schedule
• Creating and updating a new system of interaction and monthly plan adjustments
• Forming Access plans and controlling business continuity plans/ disaster recovery plans for computerized systems (manufacturing and analytical equipment and machines)
• Formulate templates for the newly introduced documentations
• Presenting new projects and features being presented plus the escalations for the quality councils
• Following up on interdepartmental interactions
• Supporting both qualification and calibration procedures
• Executing the CSV life cycle and produce documentations regarding both control Systems and analytical systems-performing GAP analysis vs QMS and guidelines + forming mitigation plans to breach the gap