QA Compliance and System Specialist
Apply locations EMEA, CH, Kanton St. Gallen, St. Gallen, CSL Vifor
Time type: Full time
Posted on: Posted Yesterday
Job requisition ID: R-248086
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 issue management processes
- 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 in creating change controls, DEV's, and CAPA's, data quality improvements
- Conducting self-inspections and assisting within audits
- 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 of 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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Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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