GCP quality compliance and auditor
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Company Description
Allergy Therapeutics is a pioneering immunology business with specialist experience in the research and development of allergy treatments. With a strong commercial presence in Europe, the company is now focusing on the US market. Our products are primarily sold in European countries, and our clinical development pipeline includes vaccines for grass, tree, and a peanut allergy vaccine in pre-clinical development.
Role Description
This is a full-time remote role for a GCP Quality Compliance and Auditor. The individual in this role will be responsible for ensuring regulatory compliance within the company's clinical trials and processes. Day-to-day tasks include conducting quality audits, and managing resulting CAPAs, analyzing compliance data, developing and implementing quality processes, and ensuring compliance and inspection readiness. Effective communication and analytical skills are essential for reporting findings and driving continuous improvement within the organization.
Qualifications
- Regulatory Compliance and Quality Auditing skills
- Strong Analytical Skills
- Excellent Communication and Auditing skills
- Knowledge of Good Clinical Practice (GCP) guidelines and regulations
- Detail-oriented with strong organizational skills
- Ability to work independently and remotely
- Experience in the healthcare or pharmaceutical industry is advantageous
- Bachelor's degree in a related field such as Life Sciences, Quality Management, or Regulatory Affairs
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