Responsible Person (or RP Delegate)

For our modern location in St. Gallen, we are looking for a Responsible Person (RP) or RP Delegate. In this role, you are responsible for ensuring flawless quality of all products manufactured/distributed by Vifor (International) Inc. (VIT) and Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) and all products manufactured under contract.

Your Tasks

• Technically responsible person (FvP, Responsible Person, RP) or RP Delegate according to HMG (Medicinal Products Act) in connection with the AMBV (Medicinal Products Licensing Ordinance), for items related to the "Technically Responsible Person".

• Responsible for the quality of the manufactured medicinal products and ensures compliance with the medicinal product regulations

• Release / blocking of product batches

• Ensuring that only products that meet the specifications and registered requirements are released

• Handling ongoing QA tasks of the products (Change Control requests, deviations, complaints, stability issues)

• Managing QA aspects in the development of new products

• Participation in conducting internal and external audits

• Participation in quality assurance projects

• Leadership of employees (optional)

Your Profile

Minimum Requirements:

• Education at a university with a degree in pharmacy, biochemistry, biology or chemistry

• Several years of experience in quality assurance or pharmaceutical manufacturing

• Ability to perform tasks independently and properly

• Regulation-compliant and very precise work

• Quality-conscious and solution-oriented approach

• Assertiveness, flexibility, resilience and teamwork skills

• Experienced in working with electronic databases

• Fluent language skills in German and English

Additional Requirements:

• Experience with inspection authorities such as Swissmedic and FDA

• Experience in analytics and microbiological controls

Ready for a new challenge? Then send us your application online today. Your application should include a motivation letter, a resume/CV as well as work certificates and copies of diplomas in the original language and/or relevant transcripts . Please combine your files, including CV, into one document.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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 visit https://www.csl.com/accessibility-statement .