21 sep
|
Thermo Fisher Scientific
|
España
21 sep
Thermo Fisher Scientific
España
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position: We are actively hiring experienced GCP QA Auditors Level III and
above
Locations: Spain, UK and France (remote) Candidates must be located in one of
these countries and hold the legal right to work.
Join us as a GCP Quality Assurance Auditor III/Manager and enhance our clinical
auditing processes by ensuring regulatory compliance and quality standards.
What You’ll Do:
• Conduct and/or lead a variety of client, internal or GCP audits and regulatory
inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system
audits
• Perform other types of QA audits or activities (e.g. database audits, clinical
study report audits, sample results tables, process improvement)
• Serve as a knowledgeable resource to operational departments on audit or
quality assurance subject matter
• Prepare and present audit findings and/or other related information at
departmental, internal operations or client meetings
* Travel will be required, up to 12-15 times per year (on average 1-2 times per
month) across EMEA
Education and Experience:
Essential:
* GCP Auditing
* Investigator Site Audits
Other:
• Bachelor's degree or equivalent and relevant formal academic / vocational
qualification
• Previous QA experience that provides the knowledge, skills, and abilities to
perform the job (comparable to 2+ years’).
In some cases, an equivalency, consisting of a combination of appropriate
education, training and/or directly related experience, will be considered
sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Thorough knowledge of GxP and appropriate regional research regulations and
guidelines
• Demonstrated proficiency and led a
📌 QA Auditor III to QA Manager (España)
🏢 Thermo Fisher Scientific
📍 España