Precision Medicine Group logo
Precision Medicine Group

Moving Science Closer to Health

GCP Auditor

AuditorAuditorFull TimeRemoteMid LevelTeam 1,001-5,000Since 2012H1B SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

20 hours ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

GCP Auditor

Precision Medicine Group

• Support the quality management system including SOPs, training, and CAPA • Process and maintain documentation for controlled documents • Develop and administer training for employees and/or consultants • Host client/sponsor audits and support regulatory inspections • Coordinate and conduct assessments of potential vendors including vendor audits • Conduct internal audits of quality systems • Conduct investigator site audits • Conduct trial master file audits • Participate in computer systems validation projects • Provide QA consultation and support to assigned project teams • Manage reported quality issues and associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks and identify opportunities for improvement

Job Requirements

  • Extensive knowledge of managing audits in clinical trials environment
  • Working knowledge of GCP/ICH guidelines and FDA regulations
  • Bachelor’s degree in a science, healthcare, or related field of study
  • Availability to travel up to 25% domestically and/or internationally
  • 2 or more years’ experience in QA GCP department in a related industry preferred
  • QA certification preferred (e.g., CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Benefits

  • Help shape the quality management system
  • Attend training sessions
  • Work from home
  • Opportunities in high-impact clinical trial areas

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