Sr. QA Auditor, GCP

IQVIA; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global healthcare company in France is seeking a Quality Assurance Auditor to oversee compliance audits across Europe. Ideal candidates will have at least 10 years of experience in the pharmaceutical industry, including 5 years in Quality Assurance and GCP auditing. Key responsibilities include planning audits, preparing reports, and managing quality issues. This role offers the chance to support quality initiatives and ensure adherence to regulations, policies, and procedures. Strong problem-solving skills and the ability to travel are essential.

Qualifications

• 10 years experience in pharmaceutical, technical, or related area, with 5 years in Quality Assurance.
• GCP audit experience is a must.
• Extensive knowledge of pharmaceutical research and regulatory environments.

Responsabilités

• Plan, schedule, conduct, report and close audit activities.
• Evaluate audit findings and prepare reports.
• Provide interpretation and consultation on regulations and policies.
• Manage quality issues and corrective actions.
• Present educational programs on compliance.

Connaissances

Problem solving

Risk analysis

Negotiation skills

Training capabilities

Effective organization

Communication

Team orientation

Ability to manage multiple projects

Outils

Word-processing applications

Spreadsheet applications

Database applications

Description du poste

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 maintain the electronic quality management system (eQMS) and provide 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

• Ability to travel 15-20% across Europe.
• 10 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.