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Quality assurance lead • neulußheim
- Gesponsert
Scientist im Bereich Quality Assurance - Systems mwd
AGC BiologicsHeidelberg, Baden-Württemberg, GermanyQuality Controller
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AGC BiologicsHeidelberg, Baden-Württemberg, GermanyOur purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
AGC Biologics GmbH sucht derzeit zur Untersttzung der Quality Unit im Bereich Quality Assurance Systems ab sofort und unbefristet einen Scientist (m / w / d).
Verantwortlichkeiten :
- Lieferantenqualifizierung inkl. Auditierung von Lieferanten und Verhandeln von Quality Agreements
- Begleiten bei Kundenaudits und Behrdeninspektionen
- GMP konformes Gestalten und Umsetzen unseres Qualittsmanagementsystems und fortlaufende Anpassung an neue Gesetze und Guidelines inkl. Erstellung von Management Reviews und regelmigem KPIReporting
- Dokumentenmanagement inkl. Harmonisierung der QSSysteme verschiedener AGC Biologics Standorte
- Sicherstellen der GMPCompliance whrend der Herstellung QC Prfung und Freigabe der hergestellten Wirkstoffe
- Bearbeitung von Abweichungen OOS und Change Control Verfahren inkl. CAPANachverfolgung
- Batch Record Review inkl. Vorbereiten der Chargenfreigabe der am Standort hergestellten Wirkstoffe
- Mitarbeit bei allen in der QA eines PharmaBetriebes anfallenden Ttigkeiten
Anforderungen :
Wir bieten :
Wenn wir Ihr Interesse fr diese Position geweckt haben nehmen wir Ihre Bewerbung gerne ber unser Bewerberportal entgegen.
AGC Biologics GmbH
Czernyring 22
69115 Heidelberg
Phone : 06221 / 90260
www.agcbio
Our culture at AGC Biologics is defined by the six core values : Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit www.agcbio. W ant to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Key Skills
Test Cases,SQL,Quality Assurance,Agile,TFS,Jira,Software Testing,Test Automation,Cucumber,QA / QC,SDLC,Selenium
Employment Type : Full-Time
Experience : years
Vacancy : 1