External audits / FDA preparation Assistant

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!

• 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.