Offer summary
Qualifications:
Bachelor's degree required, 8-10 years related work experience, Experience in GxP, CRO, or Laboratory environments, Knowledge of GAMP 5, FDA (GMP), GLP regulations, Understanding of computerized system validation.
Key responsabilities:
- Plan and implement computer system validation protocols
- Coordinate all validation activities and assessments
- Review and approve validation documentation
- Facilitate communication between IT and system owners
- Lead supplier audits and address systems improvements