CMC Quality Associate

Industry: Pharmaceutical / Life Sciences
Location: Malta
Basis: Full time
Remuneration: salary + benefits

Main Duties:

• Support the CMC function and ensure compliance with GMP and Quality Management System (QMS) standards.

• Maintain and review QMS data, SOPs, reports, metrics, and trend analysis.

• Monitor manufacturing batch records, stability programs, and release documents.

• Manage deviations, complaints, investigations, and CAPA actions.

• Support regulatory inspections and audits, including self-inspections.

• Track project progress, risk mitigation actions, and change controls.

• Assist in preparation and evaluation of Product Quality Reviews and related CAPAs.

What skills do you need:

• Minimum 5 years experience in GMP Operational Quality Systems for pharmaceutical or life science products.

• Knowledge of quality system processes: audits, deviations, CAPA, risk assessments, change control.

• Experience authoring SOPs, protocols, and other GxP documents.

• Strong analytical, research, and reporting skills.

Eligibility to work in the EU is a must