IQVIA
Sr.QAAuditor
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. QA Auditor at IQVIA. Skills: Quality Assurance, Process improvement, CAPA management. Review investigations. Approve Root Cause Analysis”
Industry & Context.
Root Cause Analysis; CAPA; Effectiveness Check
What They're Looking For.
Must Have
8+ years of prior relevant experience, Bachelor's Degree, 8+ years experience in pharmaceutical, technical, or related area with GXP experience, 6 years in Quality Assurance
What You'll Do.
Review investigations
Approve Root Cause Analysis
Approve Effectiveness Check plans
Track Quality Issues to closure
Track findings to closure
Evaluate policies for compliance
Evaluate procedures for compliance
Provide recommendations for process improvements
Manage quality events updates
Oversee quality events updates
Support Quality Events lifecycle
Consult internal stakeholders on audit observations
Consult internal stakeholders on inspection observations
Consult internal stakeholders on formulating CAPA plans
Assist in training new Quality Assurance staff
Assist in Onboarding of new Quality Assurance staff
Document CAPAs in eQMS
Track corrective actions
Track preventative actions
Track effectiveness checks
Collaborate QA initiatives
Support QA initiatives
Lead departmental goals
Collaborate departmental goals
Support departmental goals
Perform other work activities as assigned
Participate in regular supervision
Attend all mandatory training
Participate annually identifying development plan
Develop own development plan
Agree own development plan
Comply with IQVIA policies
Comply with IQVIA procedures
Comply with IQVIA protocols
Seek advice from Line Manager
Seek support from Line Manager
Maintain professional conduct
How You'll Work.
Team & Collaboration
Internal stakeholders; Line Manager
Communication Scope
Consultation
Process & Methodology
QA initiatives, Project management
Full Job Description
**JOB OVERVIEW** _Job Profile Summary_ Provide Quality Assurance support in managing assigned Quality Events in accordance with the IQVIA Process/System requirement. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, support in QA initiatives/projects for quality process improvements. **Responsibilities** _Essential Functions_ • Review, approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for Quality Issues and findings. • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. • Manage/oversee quality events updates in electronic quality management system (eQMS) and/or maintain the eQMS and provide support related to the Quality Events lifecycle. • Provide consultation to internal stakeholders on interpreting audit/inspection observations and formulating CAPA plans. • Assist in training/Onboarding of new Quality Assurance staff. • Accurate reporting and documentation of robust CAPAs in the electronic quality management system (eQMS) and adequate tracking of corrective and preventative actions and effectiveness checks for completion within the required timelines. • Lead/collaborate/support QA initiatives/projects for quality, process/system improvements and departmental goals. • Perform other work activities as assigned by the Line Manager. Participate in regular supervision. Attend all mandatory training. Participate annually identifying, developing and agreeing own development plan with Line Manager. Comply with all IQVIA policies, procedures and protocols. Seek advice and support from Line Manager whenever necessary. Maintain professional conduct at all times. **MINIMUM REQUIRED EDUCATION AND EXPERIENCE** _To
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