Quality Auditor

PURPOSE

Audit and Inspection - Corrective and Preventive (CAPA) review and finalisation.
Quality Issue (QI) investigation, Root casue analysis and CAPA management. 
Regulatory/eSOP query consultation for operations.

RESPONSIBILITIES

Review, approve investigations, RCA, CAPA and EC plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during simillar QA activities

- Manage Quality Issues

- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.

- Provide consultation to customers and monitors in interpretation of audit observations

- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

- Support in QA initiatives/projects for quality, process improvements

- Manage/oversee quality events updates in eQMS

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Bachelor's Degree.

More than 3 years of experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience. GCP- QA or Quality management experience is preferred.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.