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Good Clinical Practice (GCP) Senior Quality Assurance (QA) Auditor
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Full-time
- The Good Clinical Practice (GCP) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted ethically, with integrity, and in compliance with regulatory requirements and GCP guidelines.
- This role is responsible for providing QA auditing for the PDx business.
- This role will have a focus on auditing and Global Compliance support to R&D & GCP activities but also to the GMP manufacturing sites, GDP, PV, and GLP related functions.
- The role will oversee, coordinate and lead audits on behalf of PDx QRA with a focus on GCP and R&D functions including to but not limited to CRO’s, Investigator sites, Centralised Labs and specialist Non Clinical Labs. In this role insights and industry trends are to be proactively shared within PDx to ensure continued compliance and early identification of areas for continuous improvement.
- This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within all PDx departments including global clinical, non clinical and R&D. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives.
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