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 to join our team on a full-time basis! The role will involve handling duties related to GDP, Quality Assurance, Regulatory Affairs, Healthcare Compliance and Pharmacovigilance. The selected candidate will support the Regulatory Affairs Department of A.M. Mangion Ltd in ensuring compliance to the obligations required to keep a wholesale dealer License (WDL) and MAH contractual obligations.
Key Responsibilities
- Monitor compliance and maintenance of the quality manual and standard operating procedures (SOPs).
- Host third-party audits and Health Authority inspections.
- Maintain both physical and virtual documentation systems.
- Conduct regular training on updated SOPs and policies for in-house and third-party employees.
- Build and maintain strong relationships with local Health Authorities, product suppliers, and customers.
- Conduct self-inspections and audits to identify gaps in operating procedures.
- Perform risk assessments before implementing new or updated procedures.
- Ensure all distribution activities comply with GDP requirements and maintain product quality and safety throughout the supply chain.
- Collaborate with logistics, supply chain, medical affairs, and sales teams to ensure EU GDP compliance.
- Act as the primary contact for regulatory bodies and Market Authorization Holders (MAHs), ensuring compliance and reporting.
- Oversee change controls, manage deviations, and implement CAPAs.
- Handle product quality complaints and manage product recalls as necessary.
Skills and Competences
- In possession of a Bachelor’s or Master’s degree in Pharmacy.
- Hold a valid warrant to practice as a Pharmacist in Malta.
- Prior experience in regulatory affairs, ideally with a solid understanding of GDP and guidelines set by the European Medicines Agency (EMA).
- Strong leadership, communication and problem-solving skills.
- Self-motivated and capable of working independently as well as part of a team, with the ability to perform effectively under pressure and meet deadlines.
Why Join Us:
- Opportunity to work with a leading healthcare company.
- Supportive team environment with opportunities for professional development and career growth.
- Modernised premises with free on-site parking facilities.
- Flexible working environment.
Kindly send your CV and covering letter by not later than May 29th 2025 to
hr@ammangion.com
For more information about how we process your personal data throughout the recruitment process, please refer to our Job Candidate Privacy Notice via this link: https://ammangion.com.mt/privacy-notice-job-candidates/