Validierungsexperte in der Qualitätssicherung

vor 4 Wochen


Mannheim, Baden-Württemberg, Österreich Hays Professional Solutions Vollzeit

Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independentlyPreparing documentation for and participating in audits as applicableResponsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being metAble to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing complianceCommunicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive ManagementComplete daily scheduled and unscheduled activities, initiate activities independently and interactions across departments as applicableIdentify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory and drive innovation across the local organization/siteParticipates in large/global cross-functional or cross-chapter projectsBe involved in solving unique or unprecedented problems that have an impact on a part of the organization, function or chapterBuild and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships Completed Master's degree in natural sciences e.g. chemistry, biotechnology or pharmacy, alternatively a completed Bachelor's degree in natural sciences with professional experience in a comparable field Profound work experience in the GMP environment, ideally in quality assurance and quality control in dia- and/or pharmaceutical sector Profound knowledge of analytical and method development/validation as well as process and method transfer Profound knowledge of cleaning processes Experience in the preparation of process risk analyses and good process understanding Ensure implementation of regulatory requirements and review of above validation documents and inspection and test plans Experience in the creation or evaluation of process risk analyses Knowledge of deviation management and change control Profound knowledge of MS Office and Google applications e.g. G SuiteAbility to work in a team and experience in agile working 30 days leave per yearA highly motivated team and an open way of communication A very renowned company With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.