Your mission Management of site development projects in the area of pharmaceutical excipients
Creating and maintaining regulatory and quality dossiers for our products (e.g. CEP, DMF, internal dossiers)
Responsible for conducting audits from customers and certification bodies on site
Creating and maintaining quality agreements with our customers
Developing concepts in the employee training programme for pharmaceutical excipients, as well as carrying out and further developing this concepts, including performance reviews
Auditor for internal and external audits, supplier audits and cross audits within the Kolb Group and KLK Oleo Europe
Support of internal and external stakeholders with regulatory pharmaceutical and GMP knowledge
Monitoring of pharmaceutical relevant and related regulations and implementation of necessary measures
Support in setting up and managing the GMP management system for the manufacture of pharmaceutical excipients (EXCiPACT) within the overall management system
Collaboration in the day-to-day business of pharma quality assurance (if required)
Support in the harmonisation of activities and documents for the European sites
Participation in relevant conferences for the pharmaceutical excipient sector.
Your profile Degree from University of Applied Science (FH) or University/ETH qualified in a natural science discipline (Pharmaceutical Science, Biotechnology, Chemistry etc.)
At least 4 years of professional experience in quality assurance / regulatory affairs in a GMP environment
Excellent GMP knowledge
Pharmacopoeia knowledge desirable
Communicative and customer orientated personality who can convincingly integrate requirements from authorities, customers and internal departments into interdisciplinary teams
Team player with a pragmatic way of working and strong analytical skills
Confident handling of MS Office applications
Fluency in German (C1) and English (C1)
Our offer A challenging, versatile and responsible job in a rapidly growing international company
Flexible working hours with the option of remote working (1-2 days per week)
Personal and professional development opportunities with attractive employment conditions
Work location close to the railway station and very easy to reach by train from Zurich and Zug in a short time
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