Quality Assurance Systems 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
- Quality oversight over change control and risk management processes in TrackWise system
- 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
- Proactive support in coordination of changes to achieve RFT and on-time execution
- Tracking and monitoring of Quality KPI’s
- Driving continuous improvement
- Interdisciplinary cooperation between departments and sites
- Participation in internal and external audits
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
- 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 and problem solving
- Fluent in written and spoken English