Specialist QA / Qualified Person (IDQ - BELUX)
Amgen
- Diegem, Brabant Flamand
- CDI
- Temps-plein
- Carry out all duties in such to ensure that Amgen sa-nv can demonstrate compliance with EU-GMP and EU-GDP
- Decide upon product release of medical product for the local market
- Ensure that suppliers are properly approved and qualified
- Review annual product quality reviews of marketed products
- Provide oversight for all aspects related to in-country product distribution and storage
- Perform a periodic review to ensure that customers are entitling to receive medicinal product
- Own, review, and approve quality-related documentation (e.g. SOPs, Forms, Training, Risk Assessments, etc)
- Initiate, Own, review and/or approve deviations, CAPA and temperature excursion, and review distribution complaints
- Perform impact assessment as part of change controls impacting local processes
- Manage/oversee product complaints handling process including incoming intake and notify complainants of complaint closure (where required)
- Decide on the final disposition of returned, rejected, re-called or falsified products
- Execute product recall at local level
- Contribute to and drive continuous improvement and digital innovation projects in cross-functional collaboration
- Participate in or lead internal audits and regulatory inspections
- Assist in the development and delivery of GMP/GDP training for local staff
- Ensure that any additional requirements imposed on certain products by FAMHP and national law are adhered
- Participate in the provision of Samples distributed in Belgium and Luxembourg as per Belgian Royal Decree 11/01/1993 for Amgen’s Marketing Authorization Holders
- Master in Pharmaceutical Sciences
- Registration on the list of Qualified Persons as required per RD 14/12/2006
- Minimum 3 years’ experience in Quality Assurance in the pharmaceutical, biotechnology, or medical devices industry in affiliate setting
- Previous practical experience in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person)
- Knowledge on Belgian and Luxembourg regulations in relation to Manufacturing, Importation, Wholesale Distribution, Import, Export and Foreign trade , Guidelines on Good Manufacturing Practice (EU GMP) (Eudralex Volume 4), Guidelines on Good Distribution Practice (EU GDP) of medicinal products for human use (2013/C 343/01), European Community Directive D2001/83/EC relating to trade abroad activities, European Falsified Medicines Directive (2011/62/EU), and the European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products (92/25/EEC)
- Ability to problem solve and make scientific risk-based decisions
- Demonstrated proficiency in written and verbal communication skills (including technical writing and presentations) with the ability to effectively communicate and collaborate with production and technical staff
- Fluency in English; Dutch and French as beneficial