CMC Quality Associate

Our client is growing their team in Malta and they are looking for a CMC Quality Associate. Reporting to the Quality Manager, your responsibilities include:

• Manage and oversee the Quality Management System (QMS) by developing procedures, compiling quality metrics, and supporting data-driven decisions. 
• Provide quality oversight for operational activities, including SOPs, and ensure compliance with GMP requirements.
• Support the CMC function by addressing GMP and QMS-related queries, tracking project progress, and ensuring timely follow-up on CAPAs, deviations, and change control actions. 
• Maintain stability programs, monitor release data, review manufacturing records, and oversee the issuing and evaluation of Product Quality Reviews.
• Handle investigations of manufacturing deviations and complaints, track CAPAs, and utilize quality tools to conduct root cause analyses and drive continuous improvement. 
• Monitor and manage risks, change controls, and ensure effective communication with third-party suppliers.
• Participate in internal and external audits, self-inspections, and regulatory inspections to maintain compliance and readiness. 
• Contribute to overall QMS operations and support other reasonable activities as needed.

Requirements

• Minimum 5 years of experience working in a similar role within the pharmaceutical industry.
• Experience in utilising of quality System processes (such as, Audit, Deviations, CAPA, Risk assessments & Change Control)
• Fluency in English, both written and verbal.
• Experience of authoring SOPs, reports, protocols and other GxP documents.
• Ability to work in a fast-paced environment and under pressure.
• Must be already based in Malta.

Benefits

• Hybrid work model
• 10% performance bonus
• Health and life insurance
• Mobile phone and mobile allowance
• Free parking
• Wellbeing program

Job Reference: YB224