07 oct
|
Thermo Fisher Scientific
|
España
07 oct
Thermo Fisher Scientific
España
Thermo Fisher Scientific seeks an experienced GCP Quality Assurance Auditor III to conduct clinical audits, ensure regulatory compliance, and support quality standards across EMEA regions. The role involves leading audits, providing GCP consultation, and presenting findings to internal and external stakeholders, with travel required approximately 12-15 times annually.
Responsibilities
- Conduct and lead GCP audits, regulatory inspections, site audits, and facility/vendor assessments
- Provide GCP consultation and support to project teams and external clients
- Lead process audits and participate in complex system audits as co-auditor
- Perform database audits, clinical study report audits, and process improvement activities
- Prepare and present audit findings at departmental, operational, and client meetings
Requirements
- GCP auditing experience
- Investigator site audit experience
- Bachelor's degree or equivalent formal qualification
- Minimum 2+ years QA experience or equivalent combination of education and related experience
- Thorough knowledge of GxP and regional research regulations
- Demonstrated proficiency leading GxP and vendor audits
- Strong root cause analysis and risk assessment capabilities
📌 QA Auditor III (España)
🏢 Thermo Fisher Scientific
📍 España