Sr. QA Auditor, GCP

1 settimana fa

Turbigo MI, Italia IQVIA A tempo pieno

OverviewPlan 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.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, IQVIA SOPs and project specific guidelines/instructionsEvaluate audit findings and prepare and distribute reports to operations staff, management, and customersProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and proceduresProvide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plansManage Quality IssuesPresent educational programs and provide guidance to operational staff on compliance proceduresReview, 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 activitiesProvide quality assurance consultancy activities and projects for clients within budget and established timelinesEvaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvementsHost audits/inspectionsEnsure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspectionsMay perform GLP Archivist duties where neededManage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycleLead/collaborate/support in QA initiatives/projects for quality, process improvementsAssist in training of new Quality Assurance staffQualificationsAbility to travel 15-20% across Europe10 years experience in pharmaceutical, technical, or related area, of which 5 years in Quality Assurance.GCP audit experience is a must.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..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.This role is not eligible for UK Visa sponsorship. #J-18808-Ljbffr

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