16683-QA Auditor 2

Overview

Conduct and support quality audits, manage quality issues and CAPAs, and provide GXP compliance consultation across IQVIA contracts.

What you'll do

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations, guidelines, customer requirements, SOPs and project-specific instructions.
• Evaluate audit findings and prepare and distribute reports to operations staff, management and customers.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies and procedures.
• Provide consultation to customers and monitors in interpreting audit observations.
• Host customer-initiated audits and mock regulatory inspections, ensure their proper conduct, and assist in regulatory facility inspections.
• Perform GLP Archivist duties where needed.
• Review and approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans, and track quality events to closure.
• Present educational programs and provide guidance to operational staff on compliance procedures.
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
• Evaluate policies and procedures for compliance and recommend continuous process improvements to management.
• Assist in training new Quality Assurance staff.
• Support QA initiatives and projects for quality and process improvement.
• Manage and oversee quality event updates in the eQMS and support the audit lifecycle within the electronic quality management system.

What you'll need

• Bachelor's Degree or equivalent combination of education, training and experience.
• 3 years of experience in pharmaceutical, technical or related area, including GXP and/or Quality Assurance experience.
• Knowledge of word-processing, spreadsheet and database applications.
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.
• Strong interpersonal skills.
• Excellent problem-solving skills.
• Effective organization, communication and team orientation skills.
• Ability to initiate assigned tasks and work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Details

• Location: Mumbai, India.