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GCP Auditor

4 days, 19 hours ago
Spain
Full-time
Junior
QA Engineer
Quality Assurance and Testing
GCP
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 104

Description

  • Support the Quality Management System, including SOPs, training, and CAPA.
  • Process and maintain controlled documentation.
  • Develop and administer training for employees and consultants.
  • Host client and sponsor audits and support regulatory inspections.
  • Coordinate and conduct vendor assessments and vendor audits.
  • Coordinate and conduct internal quality system audits.
  • Coordinate and conduct investigator site audits.
  • Coordinate and conduct trial master file audits.
  • Participate in computer systems validation projects and systems change control.
  • Provide QA consultation and support to internal and external project teams.
  • Manage reported quality issues and associated corrective and preventive actions.
  • Monitor quality systems, identify compliance risks, and recommend improvements.
  • Maintain quality and compliance trackers, databases, metrics, and files.

Requirements

  • Bachelor’s degree in a science, healthcare, or related field, or equivalent relevant experience.
  • Extensive working knowledge of audits in a clinical trials environment, including GCP, CRO process, and vendor audits.
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
  • Ability to travel up to 25% domestically and/or internationally.
  • 2+ 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.
  • Opportunity to work on research supporting groundbreaking cancer therapies.
  • Employee input is valued and ideas are encouraged and nurtured.
  • Equal Opportunity Employer.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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