IQVIA

Sr.QAAuditor

₹15–25L ~AI est. Bangalore, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Sr. QA Auditor at IQVIA. Skills: Quality Assurance, Process improvement, CAPA management. Review investigations. Approve Root Cause Analysis”

Industry & Context.

Problems you'll solve

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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