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Quality Assurance Director

2 months ago

Cary North Carolina, United States Ergomed Full time

About the Role:

Ergomed is seeking a highly skilled and experienced Quality Assurance Director to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our operations.

Key Responsibilities:

  • Performing System Audits (in-house and on-site audits; which consist of audit planning / preparation, performing an audit and writing the audit report)
  • Act as a Liaison with Client's Quality Assurance Unit/Person
  • Hosting of External Audits
  • Dealing with External Audit Reports – (evaluate auditors findings and responding accordingly)
  • Maintaining External Audits Records/Database
  • Writing and Reviewing SOPs on Quality Assurance
  • SOP Co-ordination
  • SOP Review for GCP Compliance
  • Archiving System Audits
  • Audits of Ergomed Sub-contractors in Clinical Trials Execution, such as Central Labs, Wholesale or Importation Agencies etc.
  • Phase I unit Audits
  • Reviewing Personnel Training Records (checking out staff training levels and documentation)
  • Up-dating Staff on GCP through Training Sessions
  • IT System Audits
  • Pharmacovigilance System Audits

Requirements:

  • Proven experience in Quality Assurance, preferably in a pharmaceutical or clinical trials setting
  • Strong knowledge of GCP and regulatory requirements
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
  • High level of organizational and time management skills