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!
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.
Join our Team!
Why you should work with us
Contact us
career@polpharmabiologics.com

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