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