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