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.