Senior QA Auditor (CAPA Management) at IQVIA

Purpose:

The Senior QA Auditor will plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.Prepare and distribute reports of findings to supervisor, 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.

Summary of 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, IQVIA 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 and formulation of corrective action plans
• Manage Quality Issues
• Present educational programs and provide guidance to operational staff on compliance procedures
• Review, 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
• 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
• Host 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/oversee quality events updates in eQMS and/or maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff

Required Education and Experience:

• Previous or current experience in a pharmaceutical, biotech, CRO, or other regulated area
• 5 years' experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience.
• CAPA and GCP experience
• Life Sciencesce/Pharmaceutical degree

Required Knowledge, Skills and Abilities:

• Knowledge of word-processing, spreadsheet, and database applications..
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments..
• Knowledge of quality assurance processes and procedures..
• Strong interpersonal skills..
• Excellent problem solving, risk analysis and negotiation skills..
• Strong training capabilities..
• Effective organization, communication, and team orientation skills..
• Ability to initiate assigned tasks and to work independently..
• Ability to manage multiple projects..
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.