Responsibilities

• Plan, 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 observations.
• Host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
• Manage Quality Issues.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
• Present educational programs and provide guidance to operational staff on compliance procedures.
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

Criteria / Requirements

• Bachelor's Degree in Healthcare or related field preferred
• Minimum 2-3 years’ experience in quality assurance
• Strong experience in CAPA management, audit experience is a bonus
• Knowledge of Microsoft Office applications
• Ability to prioritize and coordinate multiple work requirements to meet deadlines
• Maintain an inquisitive attitude/mind towards routine tasks
• Establish and maintain effective working relationships with internal and external stakeholders

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. https://q2labsolutions.com/careers