External audits / FDA preparation Assistant
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;
- Participation in continuous improvement of existing Quality System;
- Providing guidance regarding current trends in FDA/EMA regulations (incl. upcoming requirements and lessons learnt from);
- Operational support in maintaining compliance with FDA/EMA/internal regulations;
- Implementing solutions supporting site inspection readiness tracking;
- Conducting external cGMP or for cause audits of third parties and/or partners to ensure supplier quality-related; activities quality system requirements and follow up with suppliers for completion of corrective actions;
- Supporting quality oversight over deviation, CAPA, change control, documentation management and training processes;
- Supervision over timely implementation of eQMS tasks;
- Participation in internal and external audits.
If you have:
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or related);
- Knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry;
- Knowledge of Quality Management Systems;
- Experience in the pharmaceutical industry will be an advantage;
- Interpersonal skills that promote a collaborative and productive cooperation;
- Effective and efficient written and oral communication skills;
- Auditing competences;
- Willingness to travel (domestic and international);
- Skills in organizing and problem solving;
- 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.