Informatician - CSV, Quality Assurance (m / f / d)

CureVac Manufacturing GmbH; Tübingen; Vor Ort; EUR 45.000 - 80.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Quality Assurance Expert, der die Verantwortung für die Validierung computergestützter Systeme übernimmt. In dieser spannenden Rolle sind Sie für die Überwachung und Verbesserung der Compliance von Systemen in der pharmazeutischen Industrie zuständig. Sie arbeiten in einem dynamischen Team, das sich der medizinischen Revolution widmet und innovative Therapien entwickelt. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem sich ständig weiterentwickelnden Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Mehrjährige Erfahrung im Bereich QA CSV in der pharmazeutischen Industrie.
• Kenntnisse in cGMP und relevanten regulatorischen Anforderungen.

Aufgaben

• Überwachung und Aufrechterhaltung des konformen Validierungsstatus von computergestützten Systemen.
• Verantwortung für die Qualitätssicherung im Bereich CSV übernehmen.

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

Design. Progress. Together.

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

Your Responsibilities:

• 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

Your Qualifications:

• 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

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.