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!
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.