GCP Auditor QA
- Reference: JLS QA GCP
- Location: Merthyr Tydfil
- Salary: Upto £30k Part Time possible
- Type: Full time
- Start: ASAP
Just Life Sciences are the leading Independent Life Science Recruiter based in Cardiff.
We are seeking an experienced QA Professional who has substantial GCP experience, to join a Global CRO business which is going through another growth period.
To be successful in the role you must have understanding of the Pharmaceutical Governing Bodies and have GCP experience.
You will be a risk adverse individual who has very high standards of the quality of your work. You will have an exceptional eye for detail and be a logical thinker with experience of auditing to GCP, GMP or GLP quality standards.
Qualifications, Skills and Experience
- Should you be successful then you will
- 1. To conduct In-Process, System and Facility audits as required by Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) in accordance with the appropriate SOPs
- 2. To conduct audits of documents and data such as Clinical Protocols, Database, Clinical Reports,
- and all aspects of analytical data in accordance with the appropriate SOPs
- 3. To evaluate audit responses and ensure appropriate corrective actions are completed.
- 4. To review Phase Plans, Validation Protocols, and pharmacy documentation where appropriate.
- 5. To conduct audits in accordance with the requirements of ISO 17025
- 6. To perform external audits including Subcontractors.
- 7. To maintain an awareness of current developments in the fields of GCP, GMP and GLP and with the Standard for ISO 17025.
- 8. To provide training for operational staff in Quality Assurance procedures, GCP, GMP, and GLP.
- 9. To provide management with data and information as required, and assist in Regulatory Inspections and Sponsor Audits if required.
- 10. To aid in the investigation of non-significant and significant non-compliance.
- If you have the above experience and are looking for a new challenge then please contact justyn at justlifeciences dot com
Just Life Sciences
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