Job Overview
Support quality issues management, Customer Audit/Regulatory Inspections report response management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval, and closure. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promoting and assessing compliance with regulations, guidelines, and corporate policies. Lead/support QA initiatives/projects for quality and process improvements.
Essential Functions
• Support audit response activities across countries involved with IQVIA contracts to assess compliance with applicable regulations, customer requirements, SOPs, and project-specific guidelines.
• Evaluate audit findings and prepare responses for operations staff and management.
• Provide interpretation and consultation on regulations, guidelines, compliance status, and policies.
• Manage Quality Issues, review, approve investigations, RCA, CAPA, and EC plans. Track until closure for quality events.
• Present educational programs and guidance on compliance procedures.
• Provide QA consultancy activities and projects within budget and timelines.
• Evaluate policies and procedures for compliance and recommend improvements.
• Assist in training new QA staff.
• Support QA initiatives for quality and process improvements.
• Manage quality events in eQMS and support audit lifecycle management.
Qualifications
• Bachelor's Degree preferred.
• 3+ years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance.
• Knowledge of word-processing, spreadsheets, and databases.
• Considerable knowledge of GXP regulations and auditing techniques.
• Strong interpersonal, problem-solving, organizational, and communication skills.
• Ability to work independently, manage multiple projects, and establish effective relationships.
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IQVIA is a leading global provider of analytics, technology, and clinical research services to the life sciences industry. We aim to push the boundaries of science and data to create a healthier world. Learn more at
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