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Senior GCP Process Auditor

5 hours, 3 minutes ago
Romania
Senior
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 97

Description

  • Support the Quality Management System, including SOPs, training, and CAPA activities.
  • Process and maintain documentation for controlled documents.
  • 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 and trial master file audits.
  • Participate in computer systems validation projects and change control processes.
  • Provide QA consultation and support to internal and external project teams.
  • Manage reported quality issues, corrective actions, and preventive actions.
  • Monitor quality systems for compliance risks and opportunities for improvement.
  • Maintain quality and compliance trackers, databases, metrics, and files.

Requirements

  • Extensive, working knowledge of managing all types of audits, particularly GCP Process Audits; candidates without this experience cannot be considered.
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
  • Bachelor’s degree in a science, healthcare, or related field, or equivalent relevant experience combined with qualifications.
  • Availability to travel up to 25% domestically and/or internationally.
  • CRO experience preferred.
  • QA certification preferred, such as CQA or SQA.
  • Experience with electronic clinical trial systems such as EDC, CTMS, IxRS, or ePRO preferred.

Benefits

  • Remote work indicated by the #LI-Remote designation.
  • Opportunity to contribute to research focused on breakthrough cancer therapies and other rare disease and oncology programs.
  • Employees are encouraged to share ideas and help drive positive change within the company.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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