Job Description

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MAIN MISSIONS AND RESPONSABILITIES

Conduct and management of audits in GCP/GVP perimeters to ensure compliance with the company\'s quality policy, internal procedures and regulatory requirements.

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.

Analyse and monitor the key performance indicators of quality audits and share the analysis with the Quality Management System (QMS) team and any other relevant business.

Outsourcing management for audit activities (drafting of specifications, 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.

Advise, guide and support the concerned structures (subsidiaries, partners) in the overall management of regulatory inspections (GCP, GVP), including the preparation, follow-up and support on preparation of responses to the regulatory authoritie

SKILLS AND TRAINING REQUIRED

Expected skills : Expert on GCP, GVP and other international guidelines. Well organized, efficient, excellent interpersonal and team building skills.

Education: Medical doctor, Pharmacist, Master of science and specific Quality Assurance training.

Professional experience: At least 3 years\' experience in the conduct of GCP and or GVP audits. Experience in the preparation/hosting of GCP and or GVP inspection is a plus.

Specific skills:

Knowledge of audit methodologies to be applied to R&D and Pharmacoviliance activities,

Leadership skills,

Strong capacities to work transversally,

Be proactive.

Languages: Fully fluent in English

Travel : At least once per month

Location: Europe and Canada

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