| || • Support the Quality Assurance department of Hexal AG Oberhaching (Sandoz Biopharmaceuticals, Novartis BDTM & GDD) for maintaining, monitoring and developing the quality assurance system according to applicable GLP/GCP(GCLP)/ISO17025, ICH, as well as corporate standards of Sandoz/Novartis
• Monitor equipment qualification and computer system validation and local implementation and maintenance of business IT systems, databases and SAM system (LIMS) according e-compliance and CSV requirements
• Review of laboratory documentation as development, qualification and validation plans and reports
• Write, update, train and review SOPs, procedures
• Train employees in QA topics and create internal standard procedures
• The position holder should take over the local functional role as e-compliance manager, data integrity site lead, ISRM (IGM) coordinators.
• Planning and conduct of self-inspections of the local quality system (GLP, GCP/GCLP, ISO17025) in the area of responsibility including the follow up
• Preparation, conduct and follow-up of international authority inspections or Corporate audits