Responsible Person (RP) – Malta

About the role

Essential Pharma is seeking a Registered Pharmacist to act as the Responsible Person (RP) for its wholesale distribution activities in Malta. The RP ensures regulatory compliance, maintains product integrity, and serves as the primary liaison between the supply chain and Maltese health authorities.

Key responsibilities

• Maintain compliance with the Wholesale Dealer's Authorisation (WDA) and Good Distribution Practice (GDP) standards.
• Continuously improve and keep the Quality Management System (QMS) inspection‑ready.
• Oversee QMS audits, conduct independent checks, and manage corrective actions.
• Prepare, review, and approve SOPs and maintain robust compliance records.
• Deliver GDP training to distribution staff and qualify GDP suppliers and distributors.
• Decide disposition of damaged, returned, quarantined, counterfeit or falsified stock and notify authorities when required.
• Lead investigations of product defects and manage recall operations.
• Act as deputy Designated Person for APIs in line with GDP guidelines.

Required profile

• Registered pharmacist authorised by the Malta Medicines Authority to act as Responsible Person.
• Current registration with Maltese authorities as a Responsible Person.
• Proven experience as RP for a Wholesale Dealer's Authorisation, preferably with a Marketing Authorisation Holder.
• Demonstrated track record of regulatory compliance in a pharmaceutical distribution setting.

Required skills

• In‑depth knowledge of WDA, GDP, and QMS requirements.
• Experience preparing and approving SOPs and conducting audits.
• Ability to manage product recalls and investigations.
• Strong understanding of API distribution guidelines.