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    Presentation For Role of Quality Specialist: Harseerat Rataul

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    Michelle
    The document is a presentation for the role of Quality Specialist. It outlines the objectives of the role which include quality as a core principle and patient safety. Key outputs include achieving a quality culture, improving accountability, and continuous auditing. Key challenges include facilitating procedures, implementing strategies, and liaising with operations. The specialist's strengths include experience, regulatory knowledge, and ability to work in cross-functional teams. Support provided includes unique setup, quality management system details, and deliverable understanding.

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    Presentation For Role of Quality Specialist: Harseerat Rataul

    Uploaded by

    Michelle
    27 views8 pages
    The document is a presentation for the role of Quality Specialist. It outlines the objectives of the role which include quality as a core principle and patient safety. Key outputs include achieving a quality culture, improving accountability, and continuous auditing. Key challenges include facilitating procedures, implementing strategies, and liaising with operations. The specialist's strengths include experience, regulatory knowledge, and ability to work in cross-functional teams. Support provided includes unique setup, quality management system details, and deliverable understanding.

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    The document is a presentation for the role of Quality Specialist. It outlines the objectives of the role which include quality as a core principle and patient safety. Key outputs include achieving a quality culture, improving accountability, and continuous auditing. Key challenges include facilitating procedures, implementing strategies, and liaising with operations. The specialist's strengths include experience, regulatory knowledge, and ability to work in cross-functional teams. Support provided includes unique setup, quality management system details, and deliverable understanding.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    27 views8 pages

    Presentation For Role of Quality Specialist: Harseerat Rataul

    Uploaded by

    Michelle
    The document is a presentation for the role of Quality Specialist. It outlines the objectives of the role which include quality as a core principle and patient safety. Key outputs include achieving a quality culture, improving accountability, and continuous auditing. Key challenges include facilitating procedures, implementing strategies, and liaising with operations. The specialist's strengths include experience, regulatory knowledge, and ability to work in cross-functional teams. Support provided includes unique setup, quality management system details, and deliverable understanding.

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    Presentation for role of Quality

    Specialist

    Harseerat Rataul
    Employment history
    Clinical Pharmacist and Pharmacy Assistant and
    Clinical Data Coordinator Quality Packaging
    Sep 2012 - Dec 2014 Analyst
    Oct 2015 - Aug 2018

    Pharmacovigilance
    Associate
    Dec 2014 - Sep 2015
    Objectives of the role

    QUALITY as a Core STAKEHOLDERS


    Principle and Driving PATIENT
    ● Client/Patient
    Force behind all SAFETY ● Regulatory bodies-
    Decisions and (Optimal HPRA, HSE
    outcome & ● Management
    Strategies
    Ideal Care)
    Key outputs of the role

    ACHIEVE A QUALITY CULTURE AND STRUCTURE

    IMPROVE ACCOUNTABILITY THROUGHOUT THE


    ORGANIZATION

    CONTINUOUS AUDITING
    Engineering the start
    Understanding Communication/
    Collaboration PDCA cycle
    the QMS

    QMS IDENTIFY AND IMPLEMENT STRATEGIES

    CAPA KPI’s
    Gap analysis
    (deviations) (ISO 9001:2015)
    Key challenges of the
    role:
    ● Facilitation of procedures ● GDP Training
    ● Appropriate (Directive
    documentation 2001/83/EC)
    ● Implementing strategies ● Due Diligence
    at elementary level ● Liaising with
    operations
    Strengths Support

    ❏ Ability to work in cross ❏ Unique TCP setup


    functional team and Strong ❏ Introduction and
    work ethics detail of the
    ❏ Experience current QMS being
    ❏ Knowledge of the implemented
    regulatory framework as it ❏ Understanding the
    applies to the industry deliverables
    ❏ Academic knowledge
    References
    https://www.pharmoutsourcing.com/Featured-Articles/340034-Pharma-Require
    ments-For-Temperature-Controlled-Trailers/

    https://www.hse.ie/eng/about/qavd/patient-safety/

    https://www.hpra.ie/docs/default-source/publications-forms/guidance-docum
    ents/ia-g0011-guide-to-control-and-monitoring-of-storage-and-transportation-co
    nditions-v2.pdf?sfvrsn=18

    Thank you

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