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  • Posted: Mar 29, 2022
    Deadline: Not specified
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  • Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
    Read more about this company

     

    Country QA Head, EWA

    Job Description

    • Responsible to ensure compliance and further development, support, maintenance & constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPIs) & quality indicators (KQIs).
    • Support implementation of effective and efficient processes that fulfill regulatory requirements & expectations in a sustainable way for the global Novartis portfolio of products.
    • Ensure that the Quality Systems are compliant with the global guidelines and that all relevant regulations and legal requirements are adhered to set up a Quality System with GxP and monitor the periodic inspection and updating quality-relevant processes
    • Continually improve & harmonize the quality-relevant processes, strengthen the awareness of quality, technical service, quality-relevant product tests, eliminate barriers relevant to the process and anticipate quality problems.
    • Support the departments in case of Quality assurance questions
    • Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory /compliance risks
    • Performs self-assessments
    • Support a compliance & quality culture
    • Provides expert advice and input and harmonize and continuous optimize processes within QA area
    • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
    • Distribution of marketing samples (where applicable)

    Minimum Requirements

    • People Leadership
    • Operations Management and Execution Project Management
    • Financial Management
    • Functional Breadth
    • Fix-its/Turnarounds English
    • Risk Management
    • Quality decision making
    • Knowledge of compliance requirement for all internal and external regulations
    • Knowledge of TQM and related industry GxP standards and processes
    • Quality Standards.

    Commitment to Diversity & Inclusion:

    • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

    go to method of application ยป

    Medical Science Liaison Officer

    Job Description

    • Lead scientific engagement with their Medical Experts.
    • Implement clinical and educational strategies and respond to unsolicited medical enquiries.
    • Engage with Medical Experts (MEs) to educate on medical/scientific information
    • Ensure appropriate identification/mapping of MEs/ Key Accounts including identification of opportunities to involve MEs when a specific medical need is identified to provide support
    • Develop and execute ME engagement plans to effectively prioritize and strategically engage MEs aligned with country strategy .
    • Respond to unsolicited requests for information from MEs
    • Inform and shape medical strategy by collecting impactful insights from MEs
    • Support Novartis clinical research programs, optimize trial execution and provide scientific educational support to potential and actual study sites in collaboration with clinical operations.
    • Facilitate Investigator Initiated Trial (IIT) process upon investigator request
    • Serve as a medical resource to field matrix colleagues.

    Minimum Requirements

    • B.Pharm / Pharm.D or its equivalent MBBS 2 - 3 years work experience.

    Commitment to Diversity & Inclusion:

    • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

    Method of Application

    Use the link(s) below to apply on company website.

     

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