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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