Senior QA GCP Auditor
Posted a week ago by CK Group- Science, Clinical and Technical
RESPONSIBILITIES:
As Senior QA GCP Auditor you will ensure full GCP and GCLP compliance across all the companies clinical trial activities in the UK and EU.
Key duties will include:
- Execution of internal audits and mock inspections.
- Execution of external audits of CROs, clinical laboratories, TMFs, Investigational sites etc.
- Management of the audit process from start to finalisation of audit reports.
- Training staff on the clinical aspects of drug development, general medical knowledge related to the conduct and monitoring of oncology trials and the mechanism of action and known risks of drugs under study.
As Senior QA GCP Auditor you will require:
- Extensive GCP audit experience for IMPs gained in a sponsor company or CRO.
- Clinical operations experience in CRA, CPM or similar roles.
- Willing to travel in the UK or EU typically two audits per month.
- An in-depth knowledge of ICH-GCP requirements and the drug development process.
- Provision of training for GCP / GCLP regulations and procedures under UK and EU requirements.
BENEFITS:
Up to £68,000 per annum plus car allowance and bonus.
Location:
Home based in the UK
Apply:
It is essential that applicants hold entitlement to work in the country you will be working in. Please quote job reference (phone number removed) in all correspondence.
Entitlement to work in the UK is essential.
- Type:
- Permanent
- Start Date:
- ASAP
- Contract Length:
- N/A
- Contact Name:
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- Telephone:
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- Job Reference:
- V-104245-3
- Job ID:
- 222257329
- Applications:
- Less than 10
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