Specialist QA

**What you will do**

We are a Biotech company with high-quality standards, and this is embedded in our culture throughout the company.

Become our Specialist QA / Qualified Person in Amgen sa-nv (Diegem, Belgium) and play an important role in ensuring that our produced medicines meet the highest standards and align with regulatory requirements, to ultimately reach our patients in Belgium and Luxembourg.

The purpose of the role is to be part of the International Distribution & Quality, in charge of creating, maintaining the quality management system of Amgen sa-nv.

Join us in our commitment to quality, and together, let's elevate patient care. This is your chance to thrive in an environment where quality is at the heart of everything we do.

**In this vital role, you will**:

- 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

**WIN**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is an effective communicator with these qualifications:

- 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