Specialist QA / Qualified Person (IDQ - BELUX)

Amgen Inc.

3.6

(9)

Machelen, Belgium

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-183360

    Position summary

    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

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging