- Lead validation activities in the implementation of Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR).
- Work closely with business management and validation departments to strategically define validation approaches and solutions that add value to clients, and to project delivery.
- Partner with business clients and multi-disciplinary Accenture delivery teams to determine appropriate validation strategy and approach for specific MES projects (including interfaces to other systems).
- Develop or provide guidance on the Validation deliverables including Quality Assurance Plans, Validation and Testing Plans, Design Documents, Test Protocols and Summary Reports, Traceability Matrix etc.
- Co-ordinate and conduct informal and formal testing of MES solutions.
- Execution, Review and Approval of Validation documents, including Exception/Deviation management
- Direct the validation activities of team in the above tasks
- Bachelors’ degree in Science, Engineering or relatable technical degree
- 5+ years validation experience in a highly automated Life Sciences manufacturing environment
- Knowledge of FDA and GMP guidelines a necessity
- Working knowledge of software Development Life Cycle (SDLC) and support methodologies required.
- Understanding of Life Sciences Computer System validation processes.
- Experience with PAS|X, Syncade, PharmaSuite, XFP, POMS, Camstar or other life sciences compatible MES solutions, a distinct advantage
- A strong collaborator, able to facilitate client and internal stakeholder meetings and agendas, outcome focused and team-orientated
- Strong written and oral communication skills