Principal Auditor, GCP QA Specialist

hace 4 semanas

Zaragoza, Zaragoza, España Syneos Health Clinical A tiempo completo
Job Summary

As a Principal Auditor, GCP QA Specialist at Syneos Health Clinical, you will play a critical role in ensuring the quality and integrity of our operations. Your expertise in GxP quality assurance auditing will be instrumental in identifying and mitigating risks, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Plan and conduct audits to ensure compliance with GxP regulations and company policies.
  • Perform For Cause audits as needed to address specific issues or concerns.
  • Write and issue audit reports that clearly communicate findings and recommendations to auditees and management.
  • Review responses to audit findings to ensure appropriateness and completeness.
  • Closing assigned audits and ensuring that all necessary actions are taken.

Customer Audits/Inspections
  • Prepare for and host or support customer audits to ensure a positive experience and to identify areas for improvement.
  • Prepare for and host or support Regulatory Authority Inspections to ensure compliance with regulatory requirements.

Other
  • Serve as Lead Auditor on team-based Syneos Health audits to provide guidance and support to team members.
  • Provide training and mentorship to less experienced QA Auditors to help them develop their skills and expertise.
  • Offer guidance and training to operational staff on quality-related matters to ensure a culture of quality and compliance.
  • Write, review, or revise QA SOPs/WIs to ensure they are up-to-date and effective.

Complexity
  • Apply critical thinking to identify solutions to non-standard requests and complex problems.

Supervision
  • Require minimal instructions on day-to-day work and new assignments.

Other tasks
  • May review audit reports of peers to provide feedback and guidance.
  • May provide coaching and training to company personnel on quality-related matters.
  • Participate in local and/or company-wide special projects according to skills or talents and the needs of the organization.
  • Involves himself/herself in appropriate industry associations and other relevant forums.
  • Perform other work-related duties as assigned.
  • Moderate travel may be required (up to 50%).

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