Global Quality Assurance Manager - Computer System Validation | Qualitätsmanager (m/w/d)
medac GmbH
Job Summary
As a Global QA Manager specializing in Computer System Validation (CSV), you will play a pivotal role in shaping and implementing global guidelines for computerized systems and data integrity across the medac Group. Your daily responsibilities will include overseeing the validation of GxP-relevant IT systems, developing CSV methods in collaboration with Global Process Owners, and conducting specialized training. A unique aspect of this position is the initial two-year assignment at the production site in Dessau to lead local validation efforts before transitioning focus. This role is ideal for a professional with a strong background in pharmaceutical processes and GAMP guidelines who enjoys interdisciplinary project work. medac offers an attractive package including up to 60% remote work, performance-based bonuses, and comprehensive professional development through their internal academy, making it an excellent opportunity for those looking to make a meaningful impact in the healthcare sector.
Required Skills
Education
Completed degree in Natural Sciences, Computer Science, Engineering, or a comparable qualification.
Experience
- Professional experience in a GMP (Good Manufacturing Practice) environment
- Extensive expertise in GAMP 5 guidelines for computerized systems
- Experience in creating and revising global quality documentation
- Proven track record in managing and maintaining the validated status of global IT systems
- Practical experience in conducting professional training sessions
Languages
Additional
- Must be willing to work at the production site in Dessau (oncotec) for the first two years of employment. Proficiency in MS Office (Word, Excel, PowerPoint) and databases is required.
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