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
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.