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.