Senior GCP Auditor
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Your main mission: Conduct and management of audits in GVP perimeter to ensure compliance with the company's quality policies, internal procedures and regulatory requirements.
Your main responsibilities:
- Conduct of Pharmacovigilance audits (subsidiary, partners, service providers, system) in accordance with the annual plan
- Advise and support the audited structures in the design and implementation of corrective and preventive actions (CAPAs) to ensure compliance with regulatory requirements and internal procedures
- Approve corrective and preventive actions (CAPA) related to audits and follow up until the audit closure
- Outsourcing management for audit activities (scope of work writing, subcontractor selection, planning, of audit reports review and follow-up of activities such as report distribution, CAPA approval and audit closure)
- Lead or participate in working groups for the drafting/updating of documents related to audit activities
- Participation to regulatory, guidelines and internal quality documents trainings
- Follow-up of quality indicators to assess the efficiency of the quality management system
Your profile:
- Master of Sciences
- Strong knowledge of Good Pharmacovigilance Practices (GVP) and any guidelines related to Pharmacovigilance
- Knowledge of Audit methodology to be applied to each type of Pharmacovigilance audits
- 5 years’ experience on Quality Assurance and on GVP audit conduct
- Experience in the preparation/hosting of GVP inspection is a plus
- Leadership, strong ability to work cross-functionally and to convince
- Openness to others with good interpersonal skills
- Ability to listen and analyse
- Be proactive & curious
- Fluent in English
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.