Quality Assurance Systems Expert
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
- Quality oversight over change control and risk management processes in TrackWise system
- Active coordination with records owners to achieve RFT and on-time completion of tasks
- Ensuring change controls are thorough, accurate and complete by partnering with the team on proper change assessment and definition of tasks plan, required data, timing for completion and effectiveness checks
- Supervision over timely implementation of tasks and its properness
- Tracking and monitoring of Quality KPI’s (implementation of KPI’s dashboard)
- Mentoring colleagues working within change control and risk management systems
- Proactive recognition and resolution of quality issues
- Driving continuous improvement and improves efficiency and productivity within the group
- Interdisciplinary cooperation between departments, sites and with clients
- Participation in internal and external audits
- Supporting Quality Council meeting’s
If you have
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or related)
- 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products
- Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry
- Knowledge of Quality Management Systems
- Ability to multitask and function in a fast-paced entrepreneurial environment
- Demonstrated ability to think critically, analyze and interpret data independently
- 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.