Description
Skills:Compliance, Validation, and familiarity with U.S.FDA GxP, U.S. FDA 21CFR Part 11, ISO 9001 systems validationRole- Validation Lead
Location- Amsterdam, NL
Duration- 6months +
Language: Dutch & English language is mandatory
Job requirement:
- Adept at coordinating competing priorities and projects. Broad experience in IT project validation and proven ability to lead validation activities of complex IT projects. This should include: understanding the business; determining business & system requirements; project planning; cost estimation, assigning validation project responsibilities; negotiating project deliverables
- Outstanding communication skills, both verbal and written. Ability to engage, interact, and negotiate effectively with project team members, both IT and business.
- Strong interpersonal, leadership and mentoring skills. Thorough understanding of risk management and mitigation approaches for complex organization and project issues.
- Results-oriented, pragmatic approach to problem solving. Ability to act as advocate for consensus on complex issues.
- Thorough understanding of how to work effectively within regulated pharmaceutical environment. Familiarity with U.S. FDA GxP, and U.S. FDA 21CFR Part 11, ISO 9001 systems validation. Experience in planning and execution of U.S. FDA-related Computer Systems Validation methodologies and project management implications.
- Thorough, applied understanding of SDLC and Project Methodologies.