About You
Vifor Pharma, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization.
We are currently looking for a GMP Document Specialist to join our Quality team in St. Gallen / Zurich. In this position you will be directly reporting to the Quality Systems Management Lead.
Key Tasks:
- Administration of GMP documents
- Answering support questions regarding GMP documents
- Review and maintenance of document submissions to third parties
- Electronic workflow processing in the document processes
- Monitoring of electronic and manual document archives
- Performing internal audits on document processes (e.g., controlled copies)
- Distribution of periodic review in current database
- Updating of eDMS manuals
- Training of the process
- Support for eDMS users
- IT System User (Power User, Key User: eDMS, LMS, Trackwise)
- Support Training management
- Initiating LMS changes
- Update curricula
- Support of employees
- Initialization of process optimizations in the area of responsibility
Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent
Minimum Requirements
- Completed vocational training in the field of laboratory technician, druggist or commercial employee
- Advanced GMP experience
- Ability to work in a team
- Ability to work under pressure
- Independence
- Communication skills
- Willingness to implement new processes and changes
- German fluent, English spoken and written