Alvogen Malta Group Services Limited is looking to recruit a Quality Assurance Specialist
to join their team on a full-time basis.
This position calls for an ambitious individual, who is able to provide support to the Quality Assurance (QA) team by contributing to all activities involving quality assurance and compliance with applicable regulatory requirements and assuring that Company standards are maintained, and product integrity is preserved.
This position will report directly to the Quality Assurance Manager.
Duties include but are not limited to:
Qualifications, Experience and Requirements:
- Supporting in the maintenance of internal quality systems and GxP activities;
- Providing support to Alvogen Malta Quality team in the handling of deviations, change controls and risk assessments, training activities, preparation and review of SOPs, monitoring o SOP training gaps, qualification of vendors and customers, review of distribution documents;
- Assisting and supporting the Qualified Person in the issue of QP declarations and batch certification activities;
- Assisting in internal and external audits and in the preparation of corrective and preventive actions (CAPA) and they're respective follow-up;
- Supporting continuous improvement activities related to Alvogen’s operations In Malta;
- Supporting the Quality Assurance department in any Quality matters related to B2B business;
- Participating in quality management review meetings and assist in any follow-ups required;
- Ensure that appropriate standards of GDP in relation to ensuring that medicinal products are procured from approved and licensed sites and distributed to approved and licensed sites;
- Ensure that storage of medicinal products, including environmental parameters, are monitored in accordance with the requirements of the Wholesale Distribution License and as per EU and Maltese law;
- Ensure that appropriate standards of GDP in relation to the transport of APIs are monitored in accordance with the requirements of the guidelines on principles of GDP of active substances for medicinal products for human use;
- Ensure that the storage system segregates medicinal products with expired shelf life, damaged packages, or counterfeit products and that that first expired - first out (FEFO) system is in place to manage storage and dispatch operations;
- Ensure that assessment of returned medicinal products to saleable stock is duly carried out. This may be delegated to the QP and/or RP (or equivalent) located at the warehouse;
- Assist in the company’s Quality Risk Management system and in the preparation of CAPA in response to external and internal audits and ensure their closure;
- Keep abreast of the requirements and the latest trends in GDP/GMP.
Alvogen Malta Group Services Limited:
Alvogen is the next generation pharmaceuticals company. Our business model ensures competitive advantage through focused in-house capabilities and a network of partners for enhanced speed and flexibility. Alvogen currently has commercial operations in 35 countries around the globe, with regional hubs based in North America, Romania and Taiwan. By joining the Alvogen team, you will be joining a global network of people around the world. We all have the same vision – we compete, we challenge the status quo and we make new friends from around the world. Our respect and understanding of diversity and different views is what drives us.
- A B.Pharm qualification or equivalent;
- Industry Specific experience, ideally with the implementation of corrective action programs;
- Knowledge of tools, concepts and methodologies of Pharmaceutical Quality Management systems;
- Knowledge of relevant regulatory requirements (EU GMP & GDP);
- Good attention to detail;
- Language Requirement: - English.