Project Manager/Auditor

Luminary Group is seeking a meticulous and detail-oriented Project Manager/Auditor to join a well established Notified Body company based in Italy. client's team. In this role, you will play a key part in delivering high-quality audit services, ensuring compliance with applicable standards and regulations, and making meaningful contributions to the continuous improvement of audits and internal controls within the organization.

Responsibilities:

• Plan, execute, and lead audit engagements across various business units while ensuring adherence to established audit standards and methodologies.
• Identify and assess risks, develop audit plans, and execute fieldwork to evaluate the effectiveness of internal controls.
• Prepare and present clear, concise, and actionable audit reports to management, highlighting key findings and recommendations.
• Work closely with cross-functional teams to understand business processes and identify areas for process improvement.
• Monitor the implementation status of audit recommendations and follow up with management on audit findings.
• Provide guidance and mentorship to junior auditors, fostering professional growth and knowledge sharing.
• Stay current on industry trends and best practices to ensure audit methodologies are up-to-date.
• Assist in special projects and other responsibilities as needed, contributing to the overall success of the audit function.

• Requirements
• Coming from another institution or CTF (technical director) in pharmaceutical companies that also operate in the medical device sector
• Degree in Chemistry, Pharmacy, Biology or equivalent
• 3-5 years of experience in the pharmaceutical field and later in the medical device field or 3-5 years of experience in the medical device field containing substances
• Knowledge of industry standards and laws
• Technical knowledge of medical devices containing substances
• Intrapreneurship and organisational skills
• Analytical capacity
• Excellent interpersonal skills
• Good knowledge of English
• Italian mother tongue or fluent
• Knowledge of ISO 13485
• Ability to write technical files of medical devices containing substances
• Auditor course certificate (40 hours)