Quality System 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!
You will be responsible for:
- Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements
- Qualification of suppliers using risk-based approach and maintaining supplier quality agreements
- Providing technical mentorship and resolving quality supply chain issues with suppliers
- Evaluating whether suppliers comply to all internal and legal criteria and if they qualify as an approved source
- Monitoring of supplier quality metrics (supplier performance); number of quality events, delivery failures and other recorded incidents; regular reporting and taking corrective actions if necessary
- Creating annual schedule for external audits, carrying out external cGMP or for-cause audits of partners or third parties to ensure supplier quality-related operations meet quality system criteria
- Mentoring and coaching colleagues working with supplier qualification process
- Proactive recognition and resolution of quality issues
- Participation in internal and external audits
If you have:
- University degree in Biology, Chemistry, Pharmacy, Biotechnology or other related
- At least 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 and auditing experience
- Good interpersonal and communication skills that lead to good cooperation
- Decision-making and problem solving skills, analytical thinking
- Willingness to travel (domestic and international)
- Fluency in spoken and written English
We offer:
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more…
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.