Lead global pharmacovigilance audits for GE Health Care’s Pharmaceutical Diagnostics business, applying pharmaceutical quality assurance expertise and regulatory knowledge.
This Global Quality Assurance Auditor supports CQA with auditing focused on PV-related functions and GMP manufacturing sites. The work includes internal and external audit programs, trend analysis, and compliance assessment. You will monitor regulatory changes and support operating procedure, risk assessment, and change control updates.
Key Responsibilities: Plan, prepare, and execute internal and external audits
Analyze audit trends and quality-related data
Support regulatory inspections and customer audits
Review CAPA effectiveness and Quality Event approvals
Monitor regulatory changes and inform the company
Requirements: Bachelor’s degree or qualifying pharmaceutical industry experience
Six or more years in the pharmaceutical industry
Previous auditing experience and regulatory agency interaction
Knowledge of GPv P, c GMP, and GDP
Solid communication, analysis, and problem-solving skills
Apply pharmaceutical auditing, PV compliance, and regulatory expertise to strengthen quality oversight across GE Health Care’s global operations.
📌 Global Pharmacovigilance Quality Auditor (Fredericton)
🏢 GE Healthcare
📍 Fredericton
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