Job Description

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