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Sr GCP Auditor

Sr GCP Auditor

VeristatBasel
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

Job Description

Senior GCP Auditor

The Senior GCP (Good Clinical Practices) Auditor is responsible for execution of the Audit Plan

at Veristat. S / he will plan, conduct, report and follow up on all types of GCP audits, including

internal audits, contracted audits and vendor audits. The Senior GCP Auditor will also provide

support during sponsor audits and regulatory inspections and will support all relevant activities

associated with Veristat’s Quality Management System.

What we do

For 30 years, Veristat has built a reputation as global experts in clinical development.

  • 760+ Rare Disease Clinical Trials supported
  • 160+ Marketing Applications supported
  • In 2022 we supported 8 marketing application that received regulatory approval
  • Learn more about our core values here!

What we offer

  • A stimulating role in an international and dynamic work environment
  • Continuous development and training opportunities
  • Office or Home-Based working
  • Rewards for outstanding accomplishments

    • What we look for

  • 5+ years of relevant GCP auditing experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.
  • Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and GCP.
  • Fluent in Microsoft Project, Outlook, Word, Excel, and PowerPoint.
  • Prior experience with electronic Quality Management Systems preferred.

    • Automated Decision Making : All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

    Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.