- 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.
- 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.
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Quality Assurance Manager - Stevenage, United Kingdom - Albion Rye Associates
Description
Job 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:
Required Skills & Qualifications:
If you are looking for an opportunity that challenges you whilst supporting you in your career.... apply or drop me a call
