QA Auditor
Company Name:-
IQVIA
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organizations clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
Job Overview
Conduct and/or support audits and report preparation/distribution, Support quality issues management, Customer Audit/ Regulatory Inspections hosting, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development.
Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements
Essential FunctionsPlan, 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, Standard Operating Procedures ( SOPs) and project specific guidelines/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, and policies and procedures.
Provide consultation to customers and monitors in interpretation of audit observationsHost audits/inspections,Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
May perform GLP Archivist duties where needed.
Manage Quality IssuesReview, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans.
Track until closures for quality even
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