Quality Assurance Expert (f/m/d) CSV

CureVac; Baden-Württemberg; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen in der biopharmazeutischen Branche sucht einen Quality Assurance Expert, um das Team zu verstärken. In dieser spannenden Rolle sind Sie verantwortlich für die Überwachung und Aufrechterhaltung der Compliance von computergestützten Systemen. Sie bringen Ihre Expertise in Qualitätsmanagement und Computerized System Validation ein, um sicherzustellen, dass die Systeme den gesetzlichen Anforderungen entsprechen. Das Unternehmen fördert eine dynamische und vertrauensvolle Arbeitsumgebung, in der neue Ideen geschätzt werden. Wenn Sie eine Leidenschaft für Qualität und Innovation haben, ist dies Ihre Chance, Teil einer medizinischen Revolution zu werden.

Qualifikationen

• Mehrjährige praktische Erfahrung in einer QA CSV-Rolle in der pharmazeutischen Industrie.
• Erfahrung mit cGMP und relevanten regulatorischen Anforderungen.

Aufgaben

• Überwachung und Aufrechterhaltung des konformen Validierungsstatus von computergestützten Systemen.
• Verantwortung im CSV-Bereich und Unterstützung von Projektteams.

Kenntnisse

Qualitätsmanagement

Computerized System Validation (CSV)

cGMP

Regulatorische Anforderungen

Agile Validation

Englisch

Deutsch

Ausbildung

Abgeschlossenes Hochschulstudium in (Wirtschafts-) Informatik

Qualitätsmanagement

Tools

Veeva

SAP

MES

LIMS

Jobbeschreibung

CureVac Manufacturing GmbH, a wholly owned subsidiary of CureVac SE, is a biopharmaceutical company producing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies, prophylactic vaccines and molecular therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a

Quality Assurance Expert (f/m/d) CSV

Aufgaben

• Monitoring and maintaining the compliant validation state of computerized systems in accordance with legal requirements and company guidelines
• Taking QA responsibility and making independent decisions in the CSV (CSA) area
• Maintaining and continuously improving the functionality of Computerized System Validation processes
• Ensuring the compliant operation of regulated computerized systems throughout their life cycle in accordance with legal requirements and internal guidelines
• Maintaining the framework for CSV (CSA), including relevant documents (SOPs, validation master plan), and assisting in framework improvement
• Supporting project teams and specialist departments in the implementation of CSV
• Reviewing and approving GxP-relevant system changes

Profil

• Completed university degree in (Business) Informatics, Information Management, Quality Management, or a comparable qualification
• Several years of practical professional experience in a QA CSV role within a manufacturing company in the pharmaceutical or medical device industry, or comparable training
• Experience working with cGMP, relevant regulatory requirements, and industry best practices (e.g., GAMP 5, CFR 21 Part 11/EU GMP Annex 11, CSA, Agile Validation)
• Familiarity with validation of corporate systems such as Veeva, SAP, MES, or LIMS is an advantage
• Fluent in English, with good written and spoken German skills

Wir bieten

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding. With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us – become part of the RNA people!

Important note

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.

• Karrierestufe

  Management