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Senior GCP Process Auditor

6 hours, 16 minutes ago
Hungary
Senior
Manual QA Tester
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 controlled documents and related documentation.
  • Develop and deliver training for employees and consultants.
  • Host client and sponsor audits and support regulatory inspections.
  • Coordinate and conduct vendor assessments and vendor audits as needed.
  • Coordinate and conduct internal audits of quality systems.
  • Coordinate and conduct 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.
  • Manage reported quality issues, corrective actions, preventive actions, trackers, databases, metrics, and files.
  • Monitor quality systems for compliance risks and identify opportunities for improvement.
  • Ensure work follows applicable regulations and standards, including US FDA, EU requirements, ICH, and company policies.

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 in combination 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, and ePRO preferred.

Benefits

  • Remote work indicated by the #LI-Remote posting tag.
  • Opportunity to work on ground-breaking cancer therapies and rare disease/oncology research.
  • Employee input is valued and ideas are encouraged and nurtured.
  • Equal Opportunity Employer protections.
  • Reasonable accommodation available for applicants with disabilities.
  • Recruitment fraud protections and direct HR contact support during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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