Our client, a dynamic clinical stage biopharmaceutical company, is actively seeking a highly skilled and motivated QA GCP Auditor to join their Quality Assurance team. This role is pivotal in ensuring the highest standards of compliance with Good Clinical Practice (GCP) regulations in their clinical trials.
- Develop and execute risk-based GCP audit plans for clinical trials, ensuring comprehensive coverage of critical processes and documentation.
- Prepare detailed audit reports summarizing findings, observations, and recommendations for corrective and preventive actions (CAPA).
- Work closely with clinical operations, data management, and regulatory affairs teams to assess GCP compliance and provide guidance on corrective actions.
- Identify opportunities for process improvement and contribute to the development and enhancement of GCP quality systems.
- Interface with regulatory authorities during inspections, addressing audit-related queries and ensuring a seamless audit experience.
- Provide GCP training to internal stakeholders, fostering a culture of awareness and compliance with GCP regulations.
- Conduct thorough reviews of clinical trial documentation, ensuring accuracy, completeness, and compliance with GCP standards.
- Bachelor's or Master's degree in a relevant scientific discipline.
- Extensive experience in GCP auditing within the biopharmaceutical or clinical research industry.
- In-depth knowledge of GCP regulations, ICH guidelines, and applicable regulatory requirements.
- Strong understanding of clinical trial processes and documentation.
- Excellent communication and interpersonal skills.
- Certification as a GCP Auditor is highly desirable.
Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.
?: +41 (0) 44 5514 407