Job Requirements: • Coordinate the GxP validation activities amongst the validation and functional/ technical team members • Prepare and maintain the project plan for validation function based on overall project plan • Track and report the status of the Validation activities against the project plan • Organize validation related activities and deliverables in accordance with the project timelines. • Make sure individual validation activities are aligned with the strategic direction of the program Develop an evaluation method to assess the validation workstream strengths and identify areas for improvement • Manage Global project teams with a diverse array of Vendors, talents, and responsibilities Engage stakeholders to align validation workstream priorities, coordinate interdependencies, and navigate risks • Manage changes and intervene as needed to ensure project goals are achieved • Meet with stakeholders to make communication easy and transparent regarding project issues and decisions on services • Produce accurate and timely reporting of validation workstream status throughout the implementation (multiple releases) • Analyze program risks and update RAID log accordingly Skills: • Project management • Excellent communication (oral and written) and attention to detail • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. • Knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11 • knowledge of computer system validation and GAMP -5 standards Deliverables: • Stakeholders register • Risk & Issues (RAID) Log • Program Communications Management Plan • Program Weekly/Monthly Status report • Meeting Notes I Action Items post every meeting • Project Change Request / Change Order if any v111. Go-Live Sign Off/ Final Project Acceptance • Lessons Learnt document