Position Objective:
Participation and independent fulfillment of tasks in quality assurance according to AMWHV / EU-GMP guidelines
Responsibilities:
1. Implementation of requirements formulated in relevant EU regulations for quality management
2. Handling tasks to maintain and monitor the pharmaceutical quality management system
3. Promoting quality awareness within the company
4. Participation in document control by creating or reviewing quality-relevant documents
5. Processing deviations and changes
6. Participation in training management
7. Participation and support in conducting customer audits and regulatory inspections
8. Participation in the investigation and resolution of quality-related complaints
9. Collaboration in overarching, cross-departmental projects, as needed
10. Interface communication with other department
Your Profile:
11. Successfully completed university studies in pharmacy, veterinary medicine, natural sciences, or similar
12. Several years of relevant work experience in quality assurance, production, or quality control of a GxP-regulated pharmaceutical company or a similarly regulated company (e.g., medical device manufacturer)
13. Solid experience in quality management systems (e.g., EU-GxP, DIN ISO standards 9001 or 13485)
14. Strong technical understanding of pharmaceutical processes and business processes
15. Organizational and communication skills, as well as a sense of responsibility
16. Structured and goal-oriented action
17. Hands-on mentality with a high level of initiative
18. Strong communication skills and assertiveness
19. Very good German and English language skills in speech and writing
20. Good computer skills