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GCP Auditor

18 hours, 43 minutes ago
United Kingdom
Full-time
Junior
QA Engineer
Quality Assurance and Testing
GCP
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 92

Description

  • Support the Quality Management System, including SOPs, training, and CAPA activities.
  • Process and maintain controlled documents and related documentation.
  • Develop and administer training for employees and consultants.
  • Host client and sponsor audits and support regulatory inspections.
  • Coordinate and conduct vendor assessments, vendor audits, internal audits, investigator site audits, and trial master file audits.
  • Participate in computer systems validation projects and systems change control processes.
  • Provide QA consultation and support to internal and external project teams throughout clinical studies.
  • Support and manage quality issues and associated corrective and preventive actions.
  • Monitor quality systems, report compliance risks to QA management, and identify improvement opportunities.
  • Maintain Q&C trackers, databases, metrics, and files.

Requirements

  • Bachelor’s degree in a science, healthcare, or related field, or equivalent relevant experience.
  • Extensive working knowledge of audit management in a clinical trials environment, including GCP, CRO process, and vendor audits.
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
  • Availability to travel up to 25% domestically and/or internationally.
  • 2 or more years of experience in a QA GCP department in a related industry (preferred).
  • QA certification such as CQA or SQA preferred.
  • Experience with electronic clinical trial systems such as EDC, CTMS, IxRS, or ePRO preferred.

Benefits

  • Fully remote work arrangement.
  • Full-time position.
  • Opportunity to work on groundbreaking cancer therapies and rare disease programs.
  • Employee ideas and contributions are valued and encouraged.
  • Equal Opportunity Employer status.

Interested in this position?

Apply directly on the company website

Apply Now

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