Quality Systems Expert - External Audits
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;
- Creation, verification and approval of quality documentation;
- Preparation of annual external audits schedule;
- 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;
- 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;
- Supervision over timely implementation of eQMS tasks;
- Participation in the Inspection Readiness Program;
- Participation in internal audits;
- Participation in continuous improvement of existing Quality System.
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;
- Auditing competences;
- 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;
- Willingness to travel (domestic and international);
- 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.