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We currently offer the exciting opportunity to join the Nexelis team as Senior QA Auditor (m/w/d) in full-time to work in our office in Marburg, Germany.

Job Overview

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.

Essential Functions

• 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

Qualifications

• University degree

• 5 years’ experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance in laboratory environment. GXP experience. Equivalent combination of education, training, and experience.

• 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.

• Fluent German language skills (C2 level) and a good command of English

• Excellent problem solving, risk analysis and negotiation skills.

• Effective organization, communication, and team orientation skills and strong training capabilities.

• Ability to initiate assigned tasks, to work independently and to manage multiple projects.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV.

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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