GCP Auditor

GCP Auditor
  • Competitive
  • Permanent
  • Raleigh NC, US Raleigh Wake Co. US 27612
Job Ref: JO000123577
Sector: Clinical
Sub-sector: Clinical
Date Added: 01 October 2021

GCP Auditor

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

Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry.

Are you dedicated to quality? We are seeking a GCP Auditor role is critical as this position is involved in the preparation, conduct, and reporting of internal audits, vendor audits and more including remote QA assessments related to regulatory inspections.

Role responsibilities:

  • Communication with vendors with regard to vendor qualification audits
  • Communication with project teams or Company divisions/offices with regard to follow-up on and resolution of quality assurance (QA) audit observations requiring corrective action
  • Communication with project teams and Company divisions with regard to quality management review of essential study documents.
  • Preparation, conduct, and reporting of internal systems audits
  • Preparation, conduct, and reporting of vendor qualification, including remote assessments and onsite audits
  • Preparation, conduct, and reporting of contracted QA study audits
  • Preparation, conduct and reporting of mock onsite regulatory inspections
  • Oversight of the preparation, conduct, and reporting of internal study audits by QA Auditors
  • May be involved in the preparation, conduct, and reporting of the audits of CSRs
  • May be involved in the preparation and implementation of corrective action plans in response to external systems audits observations requiring corrective action
  • May be involved in the oversight of the preparation and implementation of corrective action plans in response to client/third party study audits observations requiring corrective actions
  • Participation in the CAPA investigation process
  • Participation in the investigations of suspected research misconduct
  • Participation in the QM review of essential study documents
  • Participation in the review of computer systems validation documentation

The Candidate Qualifications

  • College or university degree MD, PharmD or degree in life sciences is a plus
  • At least 5 years of experience in Clinical Research
  • At least 3-year industry experience in the capacity of a QA auditor or equivalent
  • Must have experience in planning, conducting and reporting all types of quality assurance audits
  • Auditing experience in USA
  • Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
  • Team oriented with superior communication and interpersonal skills Strong time management, organizational, planning and presentation skills
  • Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
  • Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)

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.



30/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Shari Hulitt

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