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
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
Berufsfeld
Standorte