Precision Medicine Group logo
Precision Medicine Group

Moving Science Closer to Health

Senior GCP Process Auditor

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

Location

Romania

Posted

9 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

Senior GCP Process Auditor

Precision Medicine Group

• Support the Quality Management System including SOPs, training and CAPA • Process and maintain documentation for controlled documents, as required • Develop and administer training for employees and/or consultants • Host client/sponsor audits and support regulatory inspections • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted • Coordinate and conduct internal audits of quality systems • Coordinate and conduct investigator site audits • Coordinate and conduct trial master file audits • Participate on computer systems validation projects and systems change control process • Provide QA consultation and support to assigned project teams internally and externally • Support and manage reported quality issues and any associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement • Maintains Q&C trackers, databases, metrics, and files • Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

Job Requirements

  • Extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
  • Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
  • Availability to travel up to 25% domestically and/or internationally
  • CRO experience preferred
  • QA certification preferred (e.g., CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities

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