My client is a Pharmaceutical company and is looking for a Consultant with knowledge in Data Integrity for a 1-year long project. The project is in the context of the implementation and partially remediation and you would be part of a team working in Data Integrity based in the Frankfurt, Germany region. At the moment the company is assessing the 300 different systems in production and Quality control. After the gap analysis the implementation will start and all of the people on-site need to be trained and guided in the new DI strategy. You will report directly into the project/program manager.
- Data Integrity - system data lifecycle assessment and remediation action plans
- Harmonizing local requirements with corporate and regulatory standards
- Developing and implementing methodologies, SOPs, system procedures Managing compliance activities for system enhancements and deviations
- Computer Systems Validation (CSV)
- Excellent knowledge in Data Integrity, not only implementation also regulations & standards
- Experience in a GMP environment
- Strong German and English communication
- Experience in CSV preferred
- Able to work together in a team
PROJECT START DATE
If you are interested in the above description, we would like to receive your CV and motivation via the "apply" button at the bottom of this page.