For our client, a world leading pharmaceutical company located in Bern, we are accepting applications from highly qualified individuals for the role of Quality Systems Specialist.
Your Challenges
The aim of the position is to support the local CAPA Lead in managing the CAPA Process (e.g. providing training on Root Cause Analysis, writing the CAPA Review Board reports, user access management), as well as, supporting in the continuous improvement.
In addition, the candidate is required to support the Document Management Process from a Quality Documentation and Quality Systems perspectives.
Essential duties
- Approve requests for new/update documents ensuring document is required and assigned to the correct process according to the local QM
- Offline review of documents ensuring Quality Documentation and Quality Systems requirements are followed
- Manage the CAPA Process (tasks: user access request and provide process-related training such as Root Cause Analysis training)
- Support further CAPA training program development and implementation
- Supports activities to manage the KPIs defined for the Department
Your Skills
- University degree in Natural Science, Medicine or Pharmacy with at least 5 years’ experience in an GMP environment
- Experience with Quality Systems applications (TrackWise and eDMS)
- Experience with CAPA Process and Root Cause Analysis tools
- Data analytical skills – experience with Tableau software is an advantage
- Excellent teamwork skills
- Ability to work in different cultural environments
- Very good verbal and written skills in German and English
- Analytical, independent thinking and problem-solving capability
- Ability to prioritize and flexibility in changing priorities as needed
Please apply directly online by clicking on "Apply Now".
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