QA Manager Qualifizierung/Validierung - Schwerpunkt IT (m/w/d)
medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
- Erarbeiten und Festlegen einer geeigneten Qualifizierungs- und Validierungsstrategie und Einstufung der Kritikalität bei IT-Systemen
- Überwachung des validen Betriebs von IT-Systemen, Ausrüstungen und Prozessen (QA Oversight)
- Kontinuierliche Weiterentwicklung der Prozesse gemäß nationalen bzw. internationalen Vorgaben (AMG, AMWHV, GMP, GAMP, CFR, etc.)
- Ausarbeitung von Qualitätsmanagement-Dokumenten
- Unterstützung der Fachbereiche bei Change Control-Verfahren
- Naturwissenschaftliches Studium oder vergleichbare Ausbildung
- Berufserfahrung im GMP- und Pharmaumfeld sowie vorzugsweise in der Computer System Validierung
- Kenntnisse der Vorgaben der EU- GMP-Richtlinien und des 21 CFR Part 11, 210, 211 sowie der Leitlinie GAMP(R) 5
- Schnelle Auffassungsgabe, kritisches Urteilsvermögen, exakte Arbeitsweise sowie sehr gutes Organisationsvermögen
- Sichere Deutsch- und Englischkenntnisse in Wort und Schrift
- Your work-life balance is important to us. We offer flexible working conditions with the option of working up to 60% of your hours remotely, 30 annual vacation days and an excellent cafeteria
- Attractive salaries and success-based bonuses for all medac employees
- Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
- A funded pension scheme and other social benefits
- We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling and childcare
- We promote sports and activities to improve our employees’ health
If you are looking for a new career challenge and a future-oriented role, then we are looking forward to receiving your application including your earliest possible starting date and salary expectations. For your convenience, please feel free to use our online application form on medac.de
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