SAP Validation Project Manager

1 week ago

California City, United States RxCloud Full time

About the job SAP Validation Project Manager 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

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