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Quality Assurance Manager

ACROSS-MEDICAL LLC. · Tbilissi

New
🇬🇧 English
CAPA management

Job description

About the role

aCROss Medical is seeking an experienced Quality Assurance Manager to lead quality assurance across its clinical operations and maintain a strong, effective Quality Management System.

Key responsibilities

  • Maintain and improve the QMS, including SOPs, document control, and training.
  • Provide quality oversight for clinical studies and ensure compliance with GCP, regulatory requirements, and client procedures.
  • Plan and conduct internal and vendor audits and maintain readiness for client audits and regulatory inspections.
  • Manage deviations, root cause investigations, and CAPAs, including effectiveness checks.
  • Support risk‑based quality management, monitor quality metrics, and drive continuous improvement.

Required profile

  • Experience in clinical research QA, preferably within a CRO.
  • Strong knowledge of ICH‑GCP.
  • Hands‑on experience with QMS, audits, and CAPA management.
  • Ability to work independently with international teams.

Required skills

  • ICH‑GCP
  • Quality Management System (QMS)
  • Audit management
  • CAPA management
  • Risk‑based quality management

Questions fréquentes

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Published 3 days ago

Expires 1 month from now

12 views · 0 interested

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ACROSS-MEDICAL LLC.

Tbilissi