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.

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

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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