QA Compliance and System Specialist

We are currently looking for a QA Compliance and System Specialist to join our team at our site in St. Gallen. Your main responsibilities will include: providing support on GMP processes to ensure compliance with company standards and GMP regulatory guidelines; developing, maintaining and improving GMP-related standard operating procedures (SOPs); supporting quality processes related to Validation, Qualification, Document Management, Deviation Management, CAPA and Change Control in the Site GMP areas.

In this position you will be directly reporting to the Head QA Compliance and Innovations.

Key Tasks

• Ensuring compliance with processes and legal regulations, conducting compliance training, as RA standard management, etc.
  
• Handling and managing IT-tickets and changes
  
• Updating and inactivating SOPs and manuals
  
• Introducing and monitoring and issue management process
  
• Preparing and executing the migration to GMP systems and archiving historical data
  
• Supporting R&D with global system integration and quality assurance during data and process transfer and archiving
  
• Optimizing and monitoring specific site processes
  
• Shop floor assistance for DEV/CAPA and CC management
  
• Support of creating change controls, DEV