Quality Assurance Manager
vor 5 Monaten
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
QA Manager / Stellvertretender Technischer Direktor
Die Stelle untersteht dem Technical Director und ist in MS2 eingruppiert.
Der Quality Assurance Manager / Deputy Technical Director gewährleistet effiziente und effektive Aktivitäten im Qualitätsbereich in Übereinstimmung mit nationalen und internationalen GXP-Anforderungen und lokalen Gesetzen sowie den internen Richtlinien von Grifols für alle von Grifols Deutschland GmbH vertriebenen Produkte.
Die Position ist entscheidend für das Management aller relevanten QS-Systeme bei Grifols Deutschland GmbH in enger Zusammenarbeit mit dem Technischen Direktor sowie dem restlichen QS-Team.
Der/die Stelleninhaber/in unterstützt den Technical Director in allen Belangen der QS-Verantwortung und nimmt gleichzeitig die Aufgaben der verantwortlichen Person nach §52a AMG wahr.
Unser Angebot:
Flexible Arbeitszeiten und die Möglichkeit auf Home-Office, 40 Stunden 30 Tage Urlaub und zusätzlich jeweils 1/2 Urlaubstag an Heiligabend und Silvester Jahresbonus je nach Zielerreichung Betriebliche Altersvorsorge sowie Direktversicherung Fortbildungen und Bildungsurlaub Mitarbeiteranerkennungsprogramm gute Anbindung an ÖPNV und Autobahn Kostenloses Parken, Ladeplätze für Elektroautos Fahrrad- und E-Bike-Leasing Regelmäßige Health & Care-AngeboteIhre Aufgaben:
Sie sind das Back-Up des Technical Director in allen Aspekten der QS-Zuständigkeiten Sie fungieren als verantwortliche Person gemäß §52a AMG und der festgelegten internen Verantwortungsmatrix (wie der Aufsichtsbehörde mitgeteilt) Die Einhaltung der Qualitätssysteme und -richtlinien von Grifols sowie der europäischen und lokalen Richtlinien und Gesetze etablieren und gewährleisten Sie Sie sind für relevante QS-Systeme, z. B. produkttechnische Reklamationen, Abweichungen, Dokumentation, Änderungskontrolle, Korrekturmaßnahmen, Schulungen und Audits gemäß der Verantwortungsmatrix und in Abstimmung mit dem QS-Team verantwortlich Die Überwachung der GXP-Konformität der Lagerung und des Vertriebs von Grifols-Produkten Durchführen von Selbstinspektionen und internen Audits sowie von externen Audits bei Vertriebshändlern, Großhändlern und anderen Dritten nach Maßgabe des Auftrags Sie erstellen, überprüfen und genehmigen Berichte über Abweichungen, CAPA, Änderungskontrolle und andere relevante QualitätsdokumenteAnforderungsprofil:
Universitätsabschluss in einem naturwissenschaftlichen Bereich (z. B. Master in Biologie, Pharmazie, Chemie). Eine Promotion ist von Vorteil Mehrjährige Berufserfahrung in Bereich Qualitätssicherung, Qualitätskontrolle oder Qualitätsmanagement Strukturierte und gründliche Arbeitsweise Selbstmotiviert, teamorientiert und fähig, Prioritäten zu setzen Sehr gute und proaktive Kommunikations- und Kooperationsfähigkeiten Erfahrung mit Dokumentenmanagementsystemen und Erfahrung im Projektmanagement Fließend in Deutsch und Englisch (schriftlich und mündlich)_____
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking for a QA Manager / Deputy Technical Director to efficiently and effectively ensure all Quality activities in compliance with national and international GXP requirements and local laws as well as Grifols internal policies for all products distributed by Grifols Deutschland GmbH.
The position is key in managing all relevant QA systems at Grifols Deutschland GmbH in close cooperation with the Technical Director as well as the rest of the QA Team.
What your responsibilities will be
You will have the opportunity to:
Serve as the responsible person according to §52a AMG and the agreed internal responsibility matrix (as notified to the supervisory authority). Be the back up to the Technical Director in all aspects of the QA-responsibilities. Provide Quality Assurance review for storage and distribution of Biopharma and Diagnostics products in Germany. Establish and ensure adherence to Grifols Quality-Systems and Policies as well as to European and local directives and legislation, including (but not limited to) maintenance of QA Systems SOPs, examining and supervising GxP compliance of storage and distribution of Grifols products, conducting self-inspections and internal audits as well as external audits of distributors, wholesalers and other third parties as assigned, etc. Manage relevant QA systems, e. g. product technical complaints, deviations, documentation, change control, corrective actions, trainings and audits according to responsibility matrix and in coordination with the QA team. Manage applications for OCABR as well as national release to the German OMCL (PEI). Ensure establishment of Quality Management Business Review programs and annual business reports in cooperation with Technical Director and QA Team. Support authority inspections. Ensure QA relationship and agreements with contracted third parties. Issue or review and approve reports for deviations, CAPA, change control and other relevant quality documents. Ensure TD/QA onboarding for new hires. Serve as the Key User for SAP QA Processes.Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master’s Degree is also required. You have at least 3 years of relevant experience in Quality Assurance, Quality Control and/or Quality Management You have knowledge of Document Management System and Project Management (desirable) You possess good communication and organization skills. You are a structured, self-motivated and results-oriented person, and team player, able to collaborate with cross functional teams to achieve the objectives. You speak fluent German and English.What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.
Information about Grifols is available at . If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
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