Jobs

    Quality Scientist - Manchester, United Kingdom - Novacyt Group

    Novacyt Group
    Novacyt Group Manchester, United Kingdom

    2 weeks ago

    Default job background
    Description
    Manufacturing Manager

    Manchester Science Park

    Contract Type :
    Full-time, 6 months FTC

    Salary & Benefits :
    Competitive Salary + Benefits
    Yourgene work in partnership with global leaders in DNA technology to advance diagnostic science.

    Yourgene's flagship in vitro diagnostic products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.

    Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services.

    In addition, Yourgene offers an NIPT testing service in the Manchester laboratory.
    Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.

    We have plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers.

    We have a fantastic opportunity for anexperienced Validation Scientist to join our team on a 6 months fixed-term contract based at our Manchester HQ located at Manchester Science Park.

    The Validation Scientist will be responsible forSOP writing and validation under ISO 13485/GMP environment and todrive validation of new processes and improvements in our manufacturing and operations teams.

    Validation of changes to Manufacturing & QC standard operating processes
    Document control within a Quality management system to ensure traceable, logical and consistent workflow and procedures.

    Liaise with appropriate departments to contribute to the rapid and effective investigation of process quality and manufacturing problems and for the development of improved QC tests and manufacturing practises.

    Improvement to Inventory management and maintenance.
    Adopt a cross functional approach through regular liaison with Manufacturing, Quality Control and Quality assurance teams to ensure testing is completed in a timely manner
    Contribute to process improvement programs and troubleshooting through the performance of non-routine operations and reporting of data.

    Maintain any relevant proficiency testing, calibration or validation work, that may be appropriate to the QC sphere of activities, as defined in Company Quality System.

    Drafting a validation policy for end users and provide training.
    Ensuing all documentation is completed around validation on the Quality management system.
    Carrying out equivalency testing on hardware and software
    HND / Degree in an appropriate Biological Science.
    QC experience in GMP / ISO13485 laboratory environment.
    Experience of the use of ABI thermal cyclers and genetic analysers.
    Good analytical approach to investigating operations & product quality issues.
    Experience of DNA extraction and quantitative analysis by spectrophotometry.
    Computer literate with competence in MS Office and Genemapper.
    Sunday 28th April, 2024
    Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce.


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