CMC Quality Associate

San Ġwann - Malta

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

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. Mon...