SAP Validation Project Manager

2 weeks ago

California City, CA, 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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