TrackWise Key User
Duchnice
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:
  • Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements;
  • TrackWise system administration supporting day-to-day operations;
  • Managing ongoing administration activities, such as: user access security, periodic system review and system life-cycle (change control);
  • Supporting projects per new modules / system releases implementation;
  • Providing technical troubleshooting in case of failure;
  • Monitoring system in order to identify potential system errors and proactive implementing solutions;
  • Supporting insurance of system’s adherence to national and international regulatory guidelines (cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines);
  • Mentoring colleagues working with TrackWise;
  • Driving continuous improvement and improves efficiency and productivity;
  • Interdisciplinary cooperation between departments, sites and with clients;
  • Participation in internal and external audits.
If you have:
  • University degree (Biology, Chemistry, Pharmacy, Biotechnology, IT or related);
  • 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products;
  • Knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry;
  • Interpersonal skills that promote a collaborative and productive cooperation;
  • Effective and efficient written and oral communication skills;
  • Skills in decision-making, problem solving, planning and organizing, coaching others and analytical thinking;
  • Fluent in written and spoken English.
Why you should work with us
Contact us
career@polpharmabiologics.com

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