Responsible Person for GDP

The A.M. Mangion Group of Companies is an organization operating in Malta and the MENA region. We are leaders in the healthcare sector and pride ourselves in being a true partner of the world’s leading multinationals in the areas of Pharmaceuticals, Medical Devices, Consumer and OTC goods, Skin and Beauty Care. We are also a major player in the Pharmacy and Clinic business.

With more than forty years of experience in the healthcare sector, the A.M. Mangion Group is an environment of positive energy, focused on innovation and dedicated to enhancing life. Critical to us being able to achieve our mission is our ability to stay true to our core values these being Trust, Loyalty, Competence, Commitment and Accountability, this reigning true in not just our corporate realm but also in relation to our approach to people.

As such we are looking for a Responsible Person for GDP to join our team on a full-time basis! Reporting directly to the Head of Regulatory Affairs, the role will entail the handling of EU GDP aspects and Quality Assurance related duties. The selected candidate will support the Regulatory Department of A.M. Mangion Ltd in ensuring compliance with the obligations required to keep a wholesale dealer License (WDL) and to meet MAH contractual obligations.

Key Responsibilities

•Monitor compliance and maintenance of the quality manual and the quality management system including all processes listed in the Company’s policies and standard operating procedures;
•Maintain proper physical and virtual documentation systems;
•Manage Change controls, Deviations and CAPAs;
•Manage Product Quality Complaints and Recalls;
•Perform regular training on current and updated SOPs and policies for in-house and third-party company employees;
•Maintain a good rapport with the local Health Authorities, product suppliers and customers and ensure efficient communication;
•Host audits from third parties and inspections from the local Health Authority;
•Conduct self-inspections to identify any potential gaps in the operating procedures;
•Conduct third party audits for GDP related activities;
•Conduct risk assessments prior to implementing new or updated procedures;
•Adhere and perform regular screening of applicable health regulations;
•Adhere to the list of responsibilities as per the EU GDP guidelines;
The ideal candidate would be:
•In possession of a Bachelor’s or Master’s degree in Pharmacy;
•Hold a valid warrant to practice as a Pharmacist in Malta;
•Be familiar with GDP, EMA and other relevant regulatory guidelines and requirements;
•Have excellent organisation and communication skills;
•Proactive and able to work on own initiative, as well as in a team;
•Problem solver;
•Able to work under pressure to meet pre-set deadlines;
•Previous experience in a similar role will be considered an asset.

If you are interested in sharing your experience, motivation and commitment with a leading pharmaceutical organization, we encourage you to submit an application together with a detailed CV which will be treated in strictest confidence.

Kindly send your application by not later than the 16th May 2024 to:

A.M. Mangion Limited offers leading pharmaceutical brands to work on and opportunities for growth. The company also offers a flexible working environment and free on-site parking facilities