Scientist Quality Assurance Site Conformance (m/f/d)
What you have to offer.
- Completed university education in natural sciences or comparable qualification and at least 2 years of professional experience in the biotechnological or pharmaceutical industry (Quality Unit preferred).
- Profound knowledge of the relevant GMP regulations and pharmaceutical regulations
- Experience in organizing audits or inspections by authorities as well as in preparing GMP documents
- Initiative, reliability, ability to work in a team and organizational talent.
- Very good knowledge of German and English (written and spoken)
- Confidence in using MS Office programs
Your duties in detail:
- Collecting regulatory innovations in the GMP environment and informing the departments about current developments
- Participation in the organization and execution of inspections by authorities and self-inspections as well as audits
- Drafting of notifications to authorities and applications in coordination with the specialist departments
- Participating in the evaluation and improvement of existing or planned processes with regard to regulatory requirements and compliance.
- Creation and maintenance of QA documents