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…