QMS Manager / Qualified Person

South of Malta | €50,000 - €55,000 Annually

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Our client within the Pharmaceutical Industry is looking for a QMS Manager / QP managing a team and reporting to the Head of QA.

Responsibilities

Oversee and manage the Quality Management System in line with EU GMP, GDP, and the Medicines Act in Malta.
Ensure full regulatory compliance with Directive 2001/83/EC, S.L. 458, and EU GDP guidelines.
Maintain readiness for all company’s licences and coordinate with the Malta Medicines Authority.
Lead day-to-day QMS operations, audits, SOPs, PQRs, CAPAs, and change control processes.
Monitor and report QMS KPIs; propose and implement continuous improvement initiatives.
Manage Technical Agreements, supplier qualifications, and regulatory inspections.
Coordinate and deliver GMP/GDP/Quality training and maintain all related documentation.
Oversee product recalls, returns, and serialisation processes in collaboration with QA and EU QA/RA/PV leadership.
Represent the company during MMA and client audits and ensure compliance with national and EU standards.

Requirements

Degree in Pharmacy, Chemistry, Pharmaceutical Science, Biology, or a related field; M.Sc./Ph.D. preferred.
Extensive experience in Pharma QA/QC with a strong background in GMP and QP responsibilities.
Solid knowledge of EU GMP, PIC/S, EMA guidelines, and quality systems (CAPA, audits, risk management).
Proven experience in QMS implementation, auditing, and supplier quality management.
Excellent leadership, communication, and coordination skills across cross-functional teams.
High attention to detail with strong analytical and reporting abilities.
Eligible and authorised as a Qualified Person (QP) under relevant EU and local regulations.

Job Reference: KE590

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+356 22588074

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