Beschreibung
For our biopharmaceutical client in Austria we are looking for Quality Assurance Manager who will be supporting the Quality Team in all GMP and GDP related issues.What will you be doing?
- Write and review Quality Assurance SOPs
- Provide expert advice in GMP and GDP and all related GMP/GDP support
- Improvement of Quality Management System
- Cooperation with Clinical Operations and CMC departments
- Manage GDP/GMP deviations, changes, and complaints occurring at external Contract Packaging and Transport Organizations and CAPA follow-up
- Plan, perform and follow-up audits of GDP/GMP vendors
- Provide trainings to departments involved in GDP/GMP activities
Your profile:
- Experience within pharmaceutical and/or biotech industry
- Knowledge about all GMP/GDP Quality Assurance aspects
- Experience with international regulations and guidelines EU / FDA cGMP regulations, GDP guidelines
- Able to work in team and soft skills
If you are interested in a confidential conversation, please get into contact with Skarlet Mark, or send an email to
Michael Bailey International is acting as an Employment Business in relation to this vacancy.