Quality Assurance Expert (f/m/d) CSV

JR Germany; Tübingen; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Join a pioneering biopharmaceutical company focused on revolutionizing medicine through innovative mRNA therapies. As a Quality Assurance Expert, you will play a crucial role in ensuring compliance and enhancing the validation processes of computerized systems. This dynamic position offers the chance to work with cutting-edge technology in a collaborative environment that values honesty, trust, and continuous improvement. If you are passionate about quality assurance and want to contribute to groundbreaking medical advancements, this opportunity is perfect for you!

Qualifikationen

• Several years of professional experience in a QA CSV role.
• Experience with cGMP, regulatory requirements, and industry best practices.

Aufgaben

• Monitor and maintain the compliant validation state of computerized systems.
• Ensure compliant operation of regulated computerized systems throughout their lifecycle.
• Support project teams in implementing Computerized System Validation.

Kenntnisse

Computerized System Validation (CSV)

Quality Assurance (QA)

cGMP and regulatory requirements

Project management

Fluent in English

Good German skills

Ausbildung

University degree in (Business) Informatics

Information Management

Quality Management

Tools

Veeva

SAP

MES

LIMS

Jobbeschreibung

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Client:

CureVac Manufacturing GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

23.04.2025

Expiry Date:

07.06.2025

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Job Description:

CureVac Manufacturing GmbH, a wholly owned subsidiary of CureVac SE, is a biopharmaceutical company producing novel drugs based on Messenger RNA (mRNA). Our focus includes cancer immunotherapies, vaccines, and molecular therapies. Our goal is to bring multiple best-in-class mRNA drugs to market.

We are looking to recruit a

Quality Assurance Expert (f/m/d) CSV

• 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 improving the functionality of Computerized System Validation processes
• Ensuring compliant operation of regulated computerized systems throughout their lifecycle 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 departments in implementing CSV
• Reviewing and approving GxP-relevant system changes
• Completed university degree in (Business) Informatics, Information Management, Quality Management, or a comparable qualification
• Several years of professional experience in a QA CSV role within the pharmaceutical or medical device manufacturing industry, or comparable training
• Experience with cGMP, 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 systems like Veeva, SAP, MES, or LIMS is advantageous
• Fluent in English; good German skills are preferred

We offer a challenging and varied opportunity with an innovative, expanding company. Join us as we work on the medical revolution with passion and responsibility, fostering honesty, trust, openness, and continuous progress. Mutual respect, reliability, and personal initiative are core values.

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