Global Quality Assurance Auditor, Pharmacovigilance

Responsibilities

• Support a program of internal and external audits for QRA
• Ensure identified actions and observations are remediated in a timely manner
• Undertake risk analysis of systems and processes to propose functional audits
• Support regulatory inspections and customer audits as a functional QA subject matter expert
• Conduct trend analysis of audit and quality related data
• Assure completion of vendor qualification and surveillance activities
• Participate in quality management system (QMS) improvements
• Provide guidance on CAPA setup and perform QA approvals of Quality Event records
• Monitor legislation and guidelines from MHRA, FDA, and EMEA

Requirements

• Bachelor's degree or high school diploma with 8+ years of pharmaceutical experience
• 6+ years of experience in the pharmaceutical industry
• Previous auditing experience
• Experience interfacing with global regulatory agencies
• Knowledge of GPvP, cGMP, and GDP
• Strong collaboration, negotiation, and conflict resolution skills

Preferred Qualifications

• Strong oral and written communication skills
• Established project management skills
• Experience applying classic Quality tools
• Ability to influence and argue positions effectively within a business context

About the Company

At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions.