Lead global pharmacovigilance audits for GE HealthCare'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 GPvP, cGMP, and GDP
- Strong communication, analysis, and problem-solving skills
Apply pharmaceutical auditing, PV compliance, and regulatory expertise to strengthen quality oversight across GE HealthCare's global operations.
Global Pharmacovigilance Quality Auditor in Ottawa employer: GE HealthCare (United States)
GE HealthCare (United States) offers a dynamic work environment focused on innovation in medical technology and digital solutions. Employees benefit from opportunities for professional growth, collaboration across diverse teams, and a commitment to continuous improvement in healthcare. The company emphasizes a culture of support and education, ensuring that staff are well-equipped to succeed in their roles.
Contact Details:
GE HealthCare (United States) Recruitment Team
