Sr. QA Auditor
Overview
Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures across IQVIA contract countries. Prepare and distribute reports of findings to supervisors operations staff management and customers. Provide consultation in interpretation of regulations guidelines policies and procedures. Support management in promotion and assessment of compliance to regulations guidelines and corporate policies.
What You'll Do13
- 1Plan 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 IQVIA SOPs and project specific guidelines/instructions
- 2Evaluate audit findings and prepare and distribute reports to operations staff management and customers
- 3Provide interpretation and consultation to project teams on regulations guidelines compliance status and policies and procedures
- 4Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
- 5Manage Quality Issues present educational programs and provide guidance to operational staff on compliance procedures
- 6Review approve investigations Root Cause Analysis RCA Corrective Action Prevention CAPA and Effectiveness Check EC plans and track till closures for quality events arising from Quality Issues Audits Inspections or during similar QA activities
- 7Provide quality assurance consultancy activities and projects for clients within budget and established timelines
- 8Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
- 9Host audits inspections Ensure proper conduct of customer initiated audits and mock regulatory inspections and assist in regulatory facility inspections
- 10May perform GLP Archivist duties where needed
- 11Manage oversee quality events updates in eQMS and maintain the electronic quality management system eQMS and provides support in relation to the audit lifecycle
- 12Lead collaborate support in QA initiativesprojects for quality process improvements
- 13Assist in training of new Quality Assurance staff
Requirements14
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons experience in pharmaceutical technical or related area of which 3 years in Quality Assurance
- 3Bachelor's Degree Pref
- 4GXP experience
- 5Knowledge of word processing spreadsheet and database applications
- 6Extensive knowledge of pharmaceutical research and development processes and regulatory environments
- 7Knowledge of quality assurance processes and procedures
- 8Strong interpersonal skills
- 9Excellent problem solving risk analysis and negotiation skills
- 10Strong training capabilities
- 11Effective organization communication and team orientation skills
- 12Ability to initiate assigned tasks and to work independently
- 13Ability to manage multiple projects
- 14Ability to establish and maintain effective working relationships with coworkers managers and clients
Salary Insight
$75 - $189k per year
Location
Required Skills
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