Senior PV QA Auditor

Job Overview

Plan, schedule and conduct independent audits to assess compliance with regulations, guidelines and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management and clients. Review, approve and follow-up on corrective and preventive action (CAPA) plans on audit findings to closure.

Provide consultation in interpretation of regulations, guidelines, policies, and procedures, and support management in the promotion and assessment of compliance to regulations, guidelines and corporate policies.

Essential Functions

• Plan, schedule, and conduct independent audits of IQVIA’s post-marketing pharmacovigilance and/or Real World Solutions activities and services to assess compliance with regulations, guidelines and operating procedures.
• Evaluate audit findings and prepare and distribute reports to operations staff, management and clients.
• Review and approve Root Cause Analysis (RCA), Corrective Action and Preventive Action (CAPA) plans and Effectiveness Checks (EC) plans for audit findings. Track and follow up on the CAPA and EC implementation to closure.
• Maintain records in the electronic Quality Management System (eQMS) in relation to the audit lifecycle.
• Provide interpretation of and consultation on regulations, guidelines, compliance status, policies and procedures to IQVIA staff.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Mentor, support and assist in the training of new or less experienced auditors.
• Support management in the development of the risk-based tactical and strategic audit plans.
• Assist in the provision of Quality Assurance data for Clients’ Pharmacovigilance System Master Files (PSMF).
• Assist in the development and reporting of quality metrics for IQVIA’s Quality Management System
• May provide Quality Assurance consultancy to IQVIA project teams and their Clients within budget and established timelines.
• May lead, collaborate or support QA improvement initiatives.
  
  

• Bachelor’s degree in a scientific or healthcare related field or equivalent.
• Five years’ post-marketing pharmacovigilance (GVP) experience in a Pharma or CRO environment.
• Three to five years’ experience in the planning, conducting and reporting of audits.
• Proven knowledge of quality assurance principles and processes.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Demonstrated ability to manage multiple responsibilities.
  
  

• Experience of GCP requirements and GCP auditing
• Knowledge and understanding of Medical Devices
• Auditing qualification (e.g. ISO 9001 Lead Auditor)