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    Projects and Quality Supervisor - Stevenage, Hertfordshire, United Kingdom - Albion Rye Associates

    Albion Rye Associates
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    Description

    Position:

    Quality Assurance Manager Location:
    Stevenage

    We are working with a dynamic and innovative small to medium-sized Biotech looking for a QA Manager (GCP) to join their team.

    Their passionate team of scientists, clinicians, and professionals are committed to translating scientific discoveries into life-changing therapies for patients worldwide.


    Key Responsibilities:
    Develop and uphold GCP/ICH compliant processes to oversee the quality of clinical trials.
    Support internal audits, CAPA, and quality management reviews.
    Collaborate with the Head of QA during regulatory agency and client audits.
    Identify non-conformances, offer recommendations, and drive quality improvements.
    Conduct vendor audits and foster continuous improvement in service delivery.
    Facilitate training for our clinical staff and manage our eQMS system effectively.
    Keep abreast of quality legislation and compliance issues, ensuring adherence to standards.


    Required Skills & Qualifications:
    Bachelor's degree in Life Science or related field.
    Minimum 3 years of CQA experience in a regulated industry.
    Proficiency in ICH/FDA GCP guidelines with practical knowledge.
    Familiarity with risk-based quality systems consistent with ICH E-6.
    Experience in FDA/EMA inspections and customer audits.
    Strong communication, attention to detail, and time management skills.
    Demonstrated work ethic and commitment to quality.

    If you are looking for an opportunity that challenges you whilst supporting you in your career.... apply or drop me a call

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