Senior Quality Auditor Job at Advanced Recruiting Partners, Québec, QC

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  • Advanced Recruiting Partners
  • Québec, QC

Job Description

Job Responsibilities

Internal Audits

  • Plans and conducts assigned audits.
  • Performs For Cause audits.
  • Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
  • Reviews responses to audit findings for appropriateness and completeness.
  • Closes assigned audits.

Customer Audits/Inspections

  • Prepares for and hosts or supports customer audits.
  • Prepares for and hosts or supports Regulatory Authority Inspections.

Other Responsibilities

  • Serves as Lead Auditor on team-based internal audits.
  • Serves as a trainer and mentor to less experienced QA auditors.

Supervision

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

Additional Tasks

  • May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
  • Performs other work-related duties as assigned.
  • Moderate travel may be required (up to 50%).

Qualifications

What We’re Looking For

  • Bachelor’s degree in a science/healthcare field or equivalent with extensive experience in GxP quality assurance auditing.
  • Previous experience in conducting multiple audit types (e.g., vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) is preferred.
  • Excellent knowledge of GxP regulatory requirements.
  • Knowledge of medical and technical terminology related to the audit types to be conducted.
  • Computer literacy appropriate to job requirements (Microsoft Office suite; basic SharePoint proficiency).
  • Able to handle multiple tasks to meet timelines in a dynamic environment.
  • Strong organizational, presentation, and interpersonal skills.
  • Cultural sensitivity to allow effective communication with stakeholders from diverse backgrounds.
  • Ability to negotiate, problem-solve, and provide constructive feedback.

Job Tags

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