Quality Auditor (GCP)

Quality Auditor (GCP)
  • Competitive
  • Permanent
  • Carrollton TX, US Carrollton DENTON US 75007
Job Ref: JO000126300
Sector: Clinical
Sub-sector: Quality
Date Added: 06 January 2022

GCP Quality Assurance Auditor

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world. Position yourself with SRG.

We are seeking a GCP Quality Assurance Auditor for a top performing global pharmaceutical development research organization. With a focus on delivering quality and on-time services across a variety of therapeutic indications the GCP Quality Assurance Auditor role will be the primary communication line for project teams with regard to internal quality assurance (QA) study audits, including audits of clinical trial database as well as follow-up on and resolution of QA study audits

Key Responsibilities:

  • Preparing audit plans for individual audits and audit/risk mitigation plans for larger projects and programs, as needed for Phase I-IV clinical trials
  • Risk based approach in the identification of audit candidates and mitigation strategies related to identified and potential compliance issues as necessary
  • Completion and/or oversight of audit plans/programs
  • Leading and overseeing or assisting with audit activities including sponsor audits, clinical site audits, key documents (CSR, protocol, TMF) audits and software and system validation documentation audits
  • Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns
  • Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP and applicable regulations

GCP Quality Assurance Auditor Candidate Qualifications

  • Bachelor's Degree is required. MD, PharmD or degree in life sciences is a plus
  • Minimum of 3 years in quality management or quality assurance within a GCP-regulated environment
  • Experience conducting investigative site audits.

The GCP Quality Assurance Auditor role is remoted based and will involve both domestic and an international travel.

Keywords: Good Clinical Practices, Quality Manager, Quality Director, Quality Auditor, Clinical Auditor.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

31/01/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Johnny Hill

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