Our purpose is to bring hope to life by enabling life-changing 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 Unterstützung 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 Behördeninspektionen
- GMP konformes Gestalten und Umsetzen unseres Qualitätsmanagementsystems und fortlaufende Anpassung an neue Gesetze und Guidelines, inkl. Erstellung von Management Reviews und regelmäßigem KPI-Reporting
- Dokumentenmanagement, inkl. Harmonisierung der QS-Systeme verschiedener AGC Biologics Standorte
- Sicherstellen der GMP-Compliance während der Herstellung, QC Prüfung und Freigabe der hergestellten Wirkstoffe
- Bearbeitung von Abweichungen, OOS und Change Control Verfahren inkl. CAPA-Nachverfolgung
- Batch Record Review inkl. Vorbereiten der Chargenfreigabe der am Standort hergestellten Wirkstoffe
- Mitarbeit bei allen in der QA eines Pharma-Betriebes anfallenden Tätigkeiten
Anforderungen:
- Naturwissenschaftliches Studium, z.B. Pharmazie, Biotechnologie, Chemie o.ä.
- QA-Erfahrung in einem pharmazeutischen / biotechnologischen Unternehmen wünschenswert
- IT-Erfahrung mit TrackWise, MS Office und Datenbanken wünschenswert
- Teamfähigkeit, Verantwortungs- und Qualitätsbewusstsein werden vorausgesetzt
- Sehr gute Deutschkenntnisse und sehr gute Englischkenntnisse sind erforderlich
- Arbeitserlaubnis
Wir bieten:
- Ein modernes Arbeitsumfeld mit spannenden Aufgaben in einer zukunftsorientierten Branche
- Teamarbeit mit einem interkulturellen und internationalem Kollegium mit kurzen Kommunikationswegen über Landesgrenzen hinweg
- Eine Unternehmenskultur geprägt durch Offenheit und Wertschätzung
- Regelmäßige Firmenevents, Vermögenswirksame Leistungen, Jobticket, Arbeitgeberzulagen zum Mittagessen, ein modernes Zeiterfassungssystem mit Gleitzeitkonto
Wenn wir Ihr Interesse für diese Position geweckt haben, nehmen wir Ihre Bewerbung gerne über unser Bewerberportal entgegen.
AGC Biologics GmbH
Czernyring 22
69115 Heidelberg
Phone: 06221 / 9026-0
www.agcbio.com
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 side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based 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 cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want 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.
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells.
Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.
We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance.
Visit www.agcbio.com to learn more.
