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Job ID193135BRPosition TitleDesign History File Manager - EngineerDivisionPHARMABusiness UnitGlobal Tech OpsCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularJob DescriptionThe successful candidate will support projects and line organization with quality systems and design control related expertise as part of the Novartis Parenteral and Topical Device Development Team.
The position offers opportunities to work in multidisciplinary teams, across projects, where specific contribution within quality systems is a key element for success. The Design Control Expert will be a single point of contact and subject matter expert responsible for independently supporting projects with Design Control expertise, QA and regulatory guidance, as well as guidance on applicable standards. The role also includes supporting process improvement initiatives in the line function, as well as supporting other QA/GMP related line activities.
Tasks and responsibilities would typically include:
• Advice new projects in setting up Design Control documentation and design history file structure
• Support projects with compliance to medical device and combination product quality standards and regulatory guidances and directives
• Provide expertise on documentation to ensure compliance to Health Authority regulations
• Review and give guidance on key design control documents such as essential requirement list, clinical evaluation report
• Support and participate in key project meetings, e.g. Design reviews
• Lead/coordinate establishment of QA agreement with third parties • Coordinate training requirements for the team regarding SOPs, GMP etc.
• Monitor release of new applicable standards and regulations
• As a key user provide guidance for internal quality tracking system (AQWA)
• Establish and manage CAPA plans
• Design and implement new document templates
• Lead / support development of new procedures and SOPs
• Monitor internal quality complianceMinimum requirements• A minimum of a bachelors degree / masters degree in relevant discipline
• Fluency in English language is required, proficiency in German as well as other languages advantageous.
• Successfully demonstrated several years experience in pharmaceutical or medical device industry (minimum 3 years) in the development, submission and commercialization of medical or drug delivery devices as a quality expert.
• Broad and in depth regulatory knowledge in parenteral drug delivery devices (Class II and III medical devices)
• Excellent track record of quality management systems, including 21CFR part 820, Medical Device directives 93/42/EEC, ISO 13485, 510k, ISO 900X etc.
• Vast experience in writing/reviewing design control documents and compilation of design history files
• Good understanding of cross-functional drug/device development processes
• Excellent communication/presentation skills as well as scientific/technical writing skills
• Excellent knowledge in GMP, GLP.