Quality Assurance Manager (m/f/d)
Luckenwalde, DE, 14943
Position Objective:
Participation and independent fulfillment of tasks in quality assurance according to AMWHV / EU-GMP guidelines
Responsibilities:
- Implementation of requirements formulated in relevant EU regulations for quality management
- Handling tasks to maintain and monitor the pharmaceutical quality management system
- Promoting quality awareness within the company
- Participation in document control by creating or reviewing quality-relevant documents
- Processing deviations and changes
- Participation in training management
- Participation and support in conducting customer audits and regulatory inspections
- Participation in the investigation and resolution of quality-related complaints
- Collaboration in overarching, cross-departmental projects, as needed
- Interface communication with other department
Your Profile:
- Successfully completed university studies in pharmacy, veterinary medicine, natural sciences, or similar
- 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)
- Solid experience in quality management systems (e.g., EU-GxP, DIN ISO standards 9001 or 13485)
- Strong technical understanding of pharmaceutical processes and business processes
- Organizational and communication skills, as well as a sense of responsibility
- Structured and goal-oriented action
- Hands-on mentality with a high level of initiative
- Strong communication skills and assertiveness
- Very good German and English language skills in speech and writing
- Good computer skills