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Specialist Quality Assurance
vor 4 Wochen
- Process external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal procedures
- Enter information about external deviations / OOX results in the database
- Assess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as needed
- Coordinate deviation / investigation related activities and present the results to the key personnel at BI
- Support and advice functional departments during processing of deviations, investigations and CAPAs
- Represent the interface between functional departments, pharmaceutical key personnel as well as subject matter experts and external partners
- Contribute to the optimization and development of the process and the supporting IT system for Deviation/Investigation / CAPA Management
- Present deviations during inspections
- Generate KPIs, overviews and trend reports related to external deviations
- Supports the qualification process of external service and material suppliers by contributing to the creation and maintenance of Quality Assurance Agreements and collection of documents and performing data entry in the corresponding electronic database
- Bachelor or Master degree with focus on natural science (e.g. Pharmaceutics, Chemisty, Biology or Biotechnology) or Professional Training with several years of experience in the pharmaceutical industry in a GMP regulated area (e.g. Quality Assurance)
- Several years of experience in the pharmaceutical industry in a GMP regulated area
- Knowledge and hands-on experience gained in GMP regulated environments in pharmaceutical development or production or quality control or quality assurance for several years
- Experience in development and manufacture of pharmaceuticals, biopharmaceuticals or ATMPs would be beneficial.
- Knowledge of international regulatory guidelines (US, EU, ICH) and quality standards for human pharmaceuticals including respective development activities and data handling.
- Knowledge of quality and risk management tools would be beneficial
- Well organized and structured working approach
- Good communication and presentation skills
- Fluency in written and spoken English and German
- Proficient in the use of personal computers
- Working in an international company With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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Specialist Quality Assurance
vor 3 Wochen
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitProcess external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal proceduresEnter information about external deviations / OOX results in the databaseAssess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as...
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Specialist Quality Assurance
vor 3 Wochen
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitProcess external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal proceduresEnter information about external deviations / OOX results in the databaseAssess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as...
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Specialist Quality Assurance
vor 4 Wochen
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitProcess external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal proceduresEnter information about external deviations / OOX results in the databaseAssess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as...
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Senior Specialist Final Release
vor 1 Monat
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitIn you new role, you provide procedural and administrative support for Qualified Persons (QP).You review release documentation for IMPs (Investigational Medicinal Products) to ensure compliance to CTAA, cGMP and internal procedures in order to support the subsequent QP release.An adequate documentation of review results and KPIs in the release file is also...
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Senior Specialist Final Release
vor 3 Wochen
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitIn you new role, you provide procedural and administrative support for Qualified Persons (QP).You review release documentation for IMPs (Investigational Medicinal Products) to ensure compliance to CTAA, cGMP and internal procedures in order to support the subsequent QP release.An adequate documentation of review results and KPIs in the release file is also...
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Senior Specialist Final Release
vor 3 Wochen
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitIn you new role, you provide procedural and administrative support for Qualified Persons (QP).You review release documentation for IMPs (Investigational Medicinal Products) to ensure compliance to CTAA, cGMP and internal procedures in order to support the subsequent QP release.An adequate documentation of review results and KPIs in the release file is also...
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Senior Specialist Final Release
vor 1 Monat
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitIn you new role, you provide procedural and administrative support for Qualified Persons (QP).You review release documentation for IMPs (Investigational Medicinal Products) to ensure compliance to CTAA, cGMP and internal procedures in order to support the subsequent QP release.An adequate documentation of review results and KPIs in the release file is also...
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IT Sales Project Implementation Specialist
vor 1 Monat
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitCollaboration with Used Car business owner for planning and creation of business proposals with IT and/ or customer experience componentsPerform initial assessment of Used Car business proposals from IT infrastructure and customer experience perspectiveProject coordination and partner integrationSupport dedicated IT infrastructure and customer experience...
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IT Sales Project Implementation Specialist
vor 3 Wochen
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitCollaboration with Used Car business owner for planning and creation of business proposals with IT and/ or customer experience componentsPerform initial assessment of Used Car business proposals from IT infrastructure and customer experience perspectiveProject coordination and partner integrationSupport dedicated IT infrastructure and customer experience...
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Quality Assurance Production
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Quality Assurance Production
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Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitUnterstützung des Fokus Factory Leiters zur Erreichung der ProduktionsqualitätszieleSicherstellung der Umsetzung von qualitätssichernden Maßnahmen im Produktionsprozess (Einhaltung der Prozessabläufe, Arbeitsanweisungen und Prüfpläne)Betreuung von Musterserien, Beurteilung und Entscheidung zur Freigabe, verantwortlich für ReferenzmusterLenkung von...
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Quality Assurance Production
vor 3 Wochen
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitUnterstützung des Fokus Factory Leiters zur Erreichung der ProduktionsqualitätszieleSicherstellung der Umsetzung von qualitätssichernden Maßnahmen im Produktionsprozess (Einhaltung der Prozessabläufe, Arbeitsanweisungen und Prüfpläne)Betreuung von Musterserien, Beurteilung und Entscheidung zur Freigabe, verantwortlich für ReferenzmusterLenkung von...
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Data Engineer
vor 1 Monat
Baden-Wurttemberg, Österreich Hays TeilzeitYour task as an experienced data engineer in the Devops environment includes, among other things, big data technologies and data warehousingYou will also oversee the provision and management of data pipelines in AWS and take care of data security and data governance in an agile environment Data Engineer with experienceBig Data Technologies: Strong knowledge...
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Spezialist Quality Assurance ITS
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Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitKoordination und Leitung von Initiativen im Schwerpunkt Informationssicherheit Durchführen von Trainings und Ertellen von Trainingsunterlagen Sicherstellung der festgelegten Qualitätsanforderungen Fundierte Kenntnisse in der IT Security, IT Compliance, Datenschutz, IT Audit, IT ProjektmanagementErfahrung im Internationalen Umfeld Fundierte...
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Spezialist Quality Assurance ITS
vor 3 Wochen
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitKoordination und Leitung von Initiativen im Schwerpunkt Informationssicherheit Durchführen von Trainings und Ertellen von Trainingsunterlagen Sicherstellung der festgelegten Qualitätsanforderungen Fundierte Kenntnisse in der IT Security, IT Compliance, Datenschutz, IT Audit, IT ProjektmanagementErfahrung im Internationalen Umfeld Fundierte...
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Spezialist Quality Assurance ITS
vor 2 Monaten
Baden-Baden, Baden-Württemberg, Österreich Hays Professional Solutions VollzeitKoordination und Leitung von Initiativen im Schwerpunkt Informationssicherheit Durchführen von Trainings und Ertellen von Trainingsunterlagen Sicherstellung der festgelegten Qualitätsanforderungen Fundierte Kenntnisse in der IT Security, IT Compliance, Datenschutz, IT Audit, IT ProjektmanagementErfahrung im Internationalen Umfeld Fundierte...
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Senior Specialist
vor 1 Monat
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitExpert advisor on SAP Hybris and good know-how of additional applications (e.g, SAP S/4HANA MM / SD)You create complex conceptual blueprint designs for IT development.You identify interdependencies between integrated applications, especially SAP MM / SD / TMS / DVH, and provide expert-level support for problem resolution.You lead various process improvement...
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Senior Specialist
vor 3 Wochen
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitExpert advisor on SAP Hybris and good know-how of additional applications (e.g, SAP S/4HANA MM / SD)You create complex conceptual blueprint designs for IT development.You identify interdependencies between integrated applications, especially SAP MM / SD / TMS / DVH, and provide expert-level support for problem resolution.You lead various process improvement...
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Control Engineer
vor 1 Monat
Baden-Wurttemberg, Österreich Hays Professional Solutions VollzeitImplement the development practices and rules as defined in the Train Control support plans Formulate a low voltage and software control design solutions that fulfils the specified customer requirementsDeliver Functional Design Description, Electrical Schemes and Electrical Products definition (with the support of the Electrical Lead Engineer) in compliance...
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Senior Specialist Ordering and Distribution
vor 1 Monat
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