Beschreibung
Senior e-Compliance Manager - GxP, SOX, Quality, eCompliance, CSV_pharma
- Ensure that the operation of the project and the delivered product, service and data is in accordance with external and internal regulations such as GxP, SOx, Data Privacy, Legal, Quality Manual
- Ensure that all efforts for compliance are focused according the Risk-Based-Approach (GAMP5).
- Evaluate and recommend an effective and appropriate project eCompliance approach amidst complex landscapes and scenarios.
- Ability to develop in parallel new eCompliance procedures based on the project approach
- Ability to effectively communicate quality issues and recommendations to improve eCompliance to Senior Management.
- Ability to create a climate of collaboration and teamwork among team members and key stakeholder groups.
Additional Skills
- Many years experiences with Computerized System Validation and GAMP5
- Very good knowledge with GxP and LifeScience
- Good communication skills in English
2 months project, maybe longer