Thermo Fisher Scientific
Supplier and Internal Quality Lead Auditor(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Dreieich
EV
Evonik Operations GmbH9 Tage
Senior Quality Manager for Product Lifecycle Projects(m/w/x)
Vollzeit
mit Homeoffice
Senior
Green Job
Keine Angabe
Darmstadt
Nejo KI-Zusammenfassung
In this role, you will focus on ensuring product quality by creating specifications, conducting supplier qualifications, and managing quality assurance agreements. Your day-to-day responsibilities will involve reviewing documentation, handling deviations, and supporting audits, all aimed at maintaining high standards throughout the product lifecycle.
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Anforderungen
- •Completed scientific degree in chemistry, pharmacy, or biology, preferably with a doctorate
- •Solid knowledge of ISO 13485 and additional regulations in quality and risk management and pharmacy
- •Leadership experience
- •Experience in project management and knowledge of Lean Quality and quality tools
- •Knowledge of production processes and facilities for medical technology or pharmaceutical products under GMP conditions, preferably in the polymer field
- •Knowledge of supplier management and auditing experience
- •Excellent verbal and written communication skills in German and English
- •Strong analytical skills, high problem-solving competence, and strong team orientation
Bachelor-Abschluss
ODER
Doktor / Ph.D.
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Create GMP specifications for raw materials and finished products
- •Support the preparation of technical finished product specifications
- •Conduct supplier qualifications and qualify external service providers as needed
- •Create and track quality assurance agreements with contract manufacturers
- •Create and track change control requests
- •Support process validation activities
- •Review manufacturing instructions and validation documents during method validation
- •Prepare quality reviews for products, raw materials, media, and equipment
- •Handle deviations, complaints, and CAPA during product introduction
- •Provide audit support and manage audits when necessary
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Deine Vorteile
Boni & Prämien
- •Performance-based remuneration
Sonstige Vorteile
- •Occupational health benefits
Flexibles Arbeiten
- •Hybrid working environment
- •Flexible working environment
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