Luminary Group is seeking a meticulous and detail-oriented Project Manager / Auditor to join a well-established Notified Body company based in Italy.
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:
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 organizational 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).
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