Consultant - Computer System Validation
MAM GruppePosted on 14/Nov/2019
- IT Security
- Frankfurt, Germany
- Accompanying IT projects to ensure computer system validation (CSV).
- Development of validation concepts taking into account the legal requirements.
- Creation of computer validation documents.
- Subproject management for validation activities; including budget creation, cost tracking and deadline tracking.
- Coordination and implementation of internal and external training.
- Execution and documentation of supplier audits.
- Ensuring compliance with regulatory requirements (compliance).
- Successfully completed bachelor/masters studies in a technical, natural or economic subject or comparable experience.
- At least 3 years relevant work experience, ideally in the regulatory environment.
- Very good knowledge of computer system validation (GMP) requirements.
- Experience in creating, maintaining and using documents in the validation environment.
- High IT affinity, SAP knowledge desirable.
- Safe handling of Microsoft Office.
- Good communication and conflict skills as well as a high team orientation.
- The ability to easily communicate complex issues and to clearly structure topics.
- High degree of initiative and dedication.
- Very good German and English knowledge, spoken and written.