CSV Manager

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!
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.
Join our Team!
Why you should work with us
Contact us
career@polpharmabiologics.com

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