Quality Release Officer

Als Quality Release Officer ondersteun je het vrijgeven van farmaceutische en vaccinbatches en zorg je ervoor dat aan alle kwaliteitseisen wordt voldaan tijdens productie en verpakking. Je werkt nauw samen met Quality Assurance, Quality Control, productie en Qualified Persons en ondersteunt onder andere deviatieonderzoeken, CAPA's, change controls en kwaliteitsprojecten.

Belangrijkste verantwoordelijkheden

- Beoordelen en ondersteunen van deviatie-, CAPA- en marktklachtonderzoeken

- Ondersteunen van GMP-kwaliteitssystemen en kwaliteitsverbeteringen

- Vertegenwoordigen van Quality binnen projecten en nieuwe productintroducties

- Ondersteunen van afdelingen bij GMP-vereisten en wijzigingen in richtlijnen

- Beoordelen en autoriseren van GMP-documentatie, waaronder SOP's, kwalificatie/validatie en change controls

- Ondersteunen van batch release-activiteiten samen met Qualified Persons

- Beoordelen van kwalificatiedocumentatie zoals URS'en, protocollen en rapporten

- Verifiëren van kwalificatiedocumenten opgesteld door externe partijen

- Samenwerken met interne klanten en verschillende afdelingen

Vereisten

- Ervaring met GMP

- Ervaring met farmaceutische verpakking en/of Quality Control is een pré

- Ervaring met kwalificatiedocumentatie en geautomatiseerde/laboratoriumsystemen

- SAP-ervaring is een pré

- Nauwkeurig, zelfstandig en resultaatgericht

- Sterke samenwerkings- en communicatieve vaardigheden

- Goede beheersing van Nederlands en Engels

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Artemis Hadjidimitriou

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