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.
n 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`s and CAPA`s, data quality improvements
Conducting self-inspections and help within audits
RA standard management, etc.
Supporting and implementing local CSV projects
Your Profile
Bachelor’s degree in Chemistry, Biology, Microbiology, etc.
3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
Demonstrated practical experience in process improvement/ optimization
Strong experience in managing end to end processes in a pharmaceutical production or other relevant environment
Fluency in German and good knowledge in English
Are you interested in this exciting opportunity? We are looking forward to receiving your online application.
About CSL Vifor
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
For more information, please visit viforpharma.com
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