Aufgabe:
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 changesQualifikation:
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 skillsWeitere Angebote in den Bereichen:
