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.