Objectives

· Ensure timely, effective and efficient day-to-day operation and management of the Quality Management System, in accordance with EU GMP and GDP and prevailing legislation, for assigned tasks.

· Ensures regulatory compliance, data integrity and quality risk management principles are implemented and adhered to.

Tasks and Responsibilities

· Management of QMS documentation, inclusive of update and maintenance of such documents, their registers, and records arising from such documentation.

· Participation in the self-inspection program, both as an auditor and as an auditee.

· Receive and deliver training on specified GMP/Quality topics for Company personnel

· Maintain the Company systems for handling personnel training and other administration matters for all Company employees.

· Take part in the management of investigations, including those arising from complaints, inspections/audits, deviations, etc..

· Review of a variety of periodical documents and reports received from third parties (e.g. product quality reviews, external audit reports, third party licenses, etc.).

· Assist in the maintenance of the Company license, site master file and related policies.

· Take part in continuous improvement initiatives, both within the scope of a team and individually.

· Upkeep and maintenance of Quality Technical Agreements and ancillary documents.

· Review and maintenance of (Item) Master Data in Oracle.

· Verification and maintenance of suppliers/ customers certifications and licensing status, and maintenance of supplier audits and qualification system.

· Review CAPA implementation to ensure all actions are satisfactory and effective.

· Takes part in the change control program, including in the preparation, review and processing of internal change requests and those arising from suppliers and clients.

· To liaise effectively with other departments to ensure assigned projects and exercises are conducted in a timely manner and in compliance with GMP.

· Assists Company representatives during regulatory and customer audits.

· Support the batch management process, Item master management process and ERP troubleshooting and activities in liaison with SC EU Eugia Subsidiary, EU Aurobindo Subsidiaries and Eugia Pharma Specialties

· Carry out other duties as may reasonably be required.

EUGIA PHARMA MALTA - Quality Assurance Specialist

Job Description