CSV Manager
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities:
- Management of CSV Team & all CSV related matters;
- Management of CSV Services;
- Management of CS Compliance and continuous inspection readiness program;
- Ensure Team growth and knowledge management;
- Ensuring Computerized Systems are managed in cGMP compliant manner;
- Shape CSV processes in Polpharma Biologics Gdansk and cooperate within global organization for processes harmonization;
- Prepare company for inspections and audits within CSV area;
- Review, compare & align CSV approach within different projects in Technical Operations, Engineering, QC, R&D and IT.
If you have:
- Higher education related to automation, robotics, IT or similar studies;
- Knowledge of cGMP and FDA requirements;
- Experience in Team and Service Management & Coordination in GxP-regulated environment; CSV, Qualification, Testing hands on experience;
- Ability to diagnose and solve problems, good work organization skills, efficient work under pressure;
- English fluent;
- Experience in automation and IT projects management.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.