Offer summary
Qualifications:
Bachelor’s level degree required, 8-10 years related work experience, Experience in GxP, CRO environments, Knowledge of GAMP 5, FDA requirements, Understanding of computerized systems regulations.Key responsabilities:
- Coordinate computerized system validation activities
- Review and approve validation documentation
- Facilitate communication between IT and system owners
- Lead supplier audits and improve processes
- Maintain knowledge of quality system requirements