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    Training and Compliance Administrator - Edinburgh, United Kingdom - Roslin Cell Therapies Limited

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    QC Compliance Specialist – Maternity Cover (12 months)

    We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives.

    Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

    31 days of annual leave, plus 4 public holidays which increases with tenure.
    ~ A competitive company pension scheme to help you save for the future.
    ~ Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
    ~ Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
    ~ Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

    We are looking for a QC Compliance Specialist to join our team on a maternity cover basis. The contract will last for 12 months.

    As QC Compliance Specialist, you will oversee all QMS activities across our QC Microbiology and Analytical operations, ensuring relevant compliance standards are maintained with a primary focus on GMP.

    Liaise with other departments in all QMS investigations, including Incident Report Triage meetings and dissemination of information to all relevant QC parties.

    Liaise between QC and Manufacturing in environmental monitoring incident report investigations.
    Provision of GQCLP training to all QC staff.
    Act as a deputy to the QC Team Leader during audits and regulatory inspections.
    Trending, monitoring, and reporting of all QC QMS metrics.

    Ensure QMS KPIs are met through the review and subsequent co-ordination of document completion within the QC team and monitoring progress against agreed timelines.

    Write, progress, and co-ordinate the completion of QC incident reports and support with root cause analysis investigations ensuring completion within agreed timescales.

    Identification and implementation of effective Corrective and Preventative Actions (CAPAs).
    Experience in QC/QA within a GMP or other highly regulated environment.
    Experience of managing deviations, CAPAs, Change Controls, Risk Assessments and RCA.
    You must have a good working knowledge of Microsoft Office.
    You will hold a degree in a Life Science subject or equivalent laboratory experience.


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