Responsibilities
- As Software Validation Manager, you lead an international project team and you are responsible for the validation of all computerized systems within Pharmaceutical Development to ensure a lean implementation and continuous improvement of CSV&C standards in the NCE division
- With your expertise, you ensure planning, configuration, installation and testing of systems considering GxP and safety requirements
- You are responsible for managing the validation activities for complex international and interdisciplinary applications. Furthermore, you will create new solutions or further develop or optimize existing applications
- Also, you cooperate with worldwide functions who are involved in the generation and maintenance of life cycle documentation
- In addition, you also create and maintain training and key user concepts and organize training for users of validated systems
Profile
- Master’s degree (e.g. MBA, MSc) in a scientific/technical field or completed technical/scientific vocational training, with professional experience
- Professional experience in validation requirements for computerized systems in the regulated environment of GxP, 21 CFR Part 11 and ISPE GAMP 5
- Good understanding of the SOPs/processes landscape of the related business area
- Project management skills and Leadership experience
- Good understanding of development data and data processing requirements as well as Business management mindset
- Good ability to work under pressure, proven communication capabilities in interdisciplinary and international cooperation and strong presentation skills
- Fluent in English and preferably in German
Benefits
- Varied activities in a renowned company
- Support in the ongoing project by our team
About Hays
IT is and always has been our core business that laid the foundation for Hays' success. We are the biggest privately owned IT recruitment agency in Germany and offer the best jobs for every career level – whether you are interested in vacancies in agile SMEs or international DAX groups. Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet! We look forward to hearing from you.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Contact at Hays
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