Job Description
Eugia Pharma Specialties Ltd., a fully integrated subsidiary of Aurobindo Pharma, specializes in general injectables and oncology, boasting a comprehensive portfolio that spans various therapeutic areas. The company operates globally with facilities and teams in the USA, Europe, Brazil, Mexico, Canada, Colombia, ANZ, and select RoW markets, employing over 150+ scientists and 4,000+ staff worldwide. Eugia aims to build an extensive specialty portfolio. Continual investment in complex injectables and advanced R&D in Hyderabad underscores Eugia’s commitment to innovation, particularly in developing peptides, long-acting injectables, and sophisticated ophthalmic and dry powder injections.
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.
- 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.
- Carry out other duties as may reasonably be required.
