Quality Assurance Expert (f/m/d) CSV
08.04.2025
CureVac Manufacturing GmbH
Tübingen bei Stuttgart
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Quality Assurance Expert (f/m/d) CSV
Tübingen bei Stuttgart
Aktualität: 08.04.2025
Anzeigeninhalt:
08.04.2025, CureVac Manufacturing GmbH
Tübingen bei Stuttgart
Quality Assurance Expert (f/m/d) CSV
Über uns:
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.
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
Qualifikationen:
- 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.
Unser Kontakt:
CureVac Manufacturing GmbH
Human Resources
Alba Ardito
Friedrich-Miescher-Straße 15
72076 Tübingen
Www.curevac.com
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