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    Quality Assurance Manager - Stevenage, United Kingdom - Albion Rye Associates

    Albion Rye Associates
    Albion Rye Associates Stevenage, United Kingdom

    2 weeks ago

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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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