Quality Systems Support Senior Specialist
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
- Electronic quality management systems administration supporting day-to-day operations
- Managing ongoing administration activities, such as: user access security, access management, 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 QMS
- 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