Quality Assurance Manager (m/f) Manufacturing - Germany
- Everyone achieves greatness at our company! As one of the most rapidly growing biotechnology companies in Europe, we’re working on revolutionary approaches in the fight against cancer and other diseases.
- Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer! Here, you’ll achieve greatness.
- As a part of our lighthouse project IVAC, you will soon take the next critical step with us.
- With our company, you will become a worldwide forerunner in the development of a completely new type of immunotherapy against cancer using individualized tumor vaccines.
Your duties in detail:
- Together with your team colleagues (m/f), you will set up and continuously improve a broad-ranging pharmaceutical quality management system for the areas of GCLP, GMP and GCP.
- You will also prepare, review, approve and revise regulatory documents (such as SOPs, plans, reports, manufacturing specifications) and assist in preparing PQRs.
- Moreover, you will help set up GMP-compliant production and provide quality assurance supervision in routine production in clean rooms.
- You will also be responsible for overseeing hygiene and monitoring measures in the production process.
- Last but not least, you will provide regulatory supervision in production and storage.
What you have to offer.
- Degree in natural sciences or completed vocational training as a biology lab technician, BTA, MTA, PTA, CTA (m/f) or equivalent qualification
- In-depth knowledge of the relevant rules in the biotechnology/pharmaceutical industry (especially GCLP, GMP and GCP)
- Practical experience in quality assurance/quality management or manufacturing
- Relevant experience in the routine manufacturing of sterile dosage forms
- Reliability, capacity for teamwork and organisational talent. Confident handling of MS Office. Very good English skills, both written and spoken