Responsibilities:
- Provides strategic advice to the client with consideration of the industries regulations and requirements
- Provides the client with strategic advice on organizational design
- Performs GxP audits, compliance assessments of information systems,integrated manufacturing systems and IT infrastructures per the GAMP 5 approach
- Identifies development opportunities in regards of the Computerized System Validation
- Leads and if necessary conducts operational support in regards of the Computerized System Validation
- Demonstrates senior leadership skills and performs interim management, coordination and/or delegation related to work scope
- Carries out in depth training in activities or procedures as related to critical project planning and high priority activities
- Possesses over excellent time management & leadership skills related critical projects and high priority activities
Profile:
- Professional level of verbal and writing skills (English and preferably the language of the country of assignment)
- Bachelor or Master degree in IT, Life Sciences or comparable
- Knowledge of regulations, quality standards and a GxP mindset
- A minimum of 8 years of experience with compliance, in life science industry or an industry with a comparable high regulatory level, is required
- Competent in MS Office products and experience with Quality Systems
We offer you:
Rescop offers a challenging position in a fast growing international environment where
we invest in the personal development of our employees. We create opportunity for
professional development, career growth, autonomy, strong rewarding and community