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    Quality Consultant - Camberley, United Kingdom - Russell Tobin

    Russell Tobin
    Russell Tobin Camberley, United Kingdom

    4 days ago

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    Description

    Quality Consultant - Camberley/ Hybrid - 12 month contract

    Job Purpose:


    • To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.


    • Gap assessment of the QMS for a new entity


    • Project planning to ensure effective and compliant integration of the current QMS with to be QMS of the established entity.


    • Ownership of the project planning and execution.


    • Implementation of project plan to ensure effective QMS in new entity.


    • Creation of Quality agreements and contracts

    Major Accountabilities:


    • Execute elements of the quality management system to support GMDP activities at the Country Organisation and, where required/experienced, support ownership of a quality process or system - this includes understanding and assessment of SOPs, documents, records and metrics related to the systems. Support evaluation any issues/gaps and improvement implementation.


    • To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.


    • Gap assessment of the QMS for a new entity


    • Project planning to ensure effective and compliant integration of current QMS with to be QMS of the established entity.


    • Ownership of the project planning and execution.


    • Implementation of the project plan to ensure effective QMS in the new entity.


    • Creation of Quality agreements and contracts


    • Support in audits/ inspections/ self-inspection programme when required.


    • Operate the Country Organisation quality activities following SOP's and using documentation/IT system confidently as required


    • Gain knowledge of IT platforms/applications required to operate tasks in those quality systems


    • Completion of training in compliance


    • Deliver on time for individual actions or commitments – or reschedule appropriately as needed. This includes own training commitments and also actions to support others (e.g. reviews and approvals)

    Education & Qualifications:

    Life science degree level

    Experience:


    • 10 years experience in the pharmaceutical industry, GxP knowledge


    • Good level of skills in the use of computer based systems and applications

    Skills & Knowledge: Strategic/Transitional Skills


    • Demonstrate Continuous Learning


    • Interpersonal relationships and collaboration


    • Operational Excellence - constructively challenge inadequate, inefficient or unnecessary processes and makes suggestions for improvements.


    • Being Resilient, Motivated, Managing multiple priorities.


    • Organisation skills - self-directed and able to flex to meet peaks in workload. Stays focused on tasks despite disruptions or obstacles

    Functional Quality Knowledge/Skills


    • Quality System Management


    • Understand Regulatory Environment - Knowledge of GMDP and other regulatory requirements relevant for country organisation


    • Quality Governance/Compliance - Support preparation for audits and inspections.


    • Project management experience for Quality

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