Over het bedrijf
Onze opdrachtgever is een internationaal opererende farmaceutische productieorganisatie die zich richt op de productie van innovatieve healthcare producten binnen een streng gereguleerde GMP-omgeving. De locatie in Boxmeer is gespecialiseerd in steriele productieprocessen en werkt met een sterke focus op kwaliteit, compliance en continue verbetering.
Functieomschrijving
Als QA Officer ondersteun je steriele en aseptische productieactiviteiten binnen een GMP-gereguleerde productieomgeving. Je werkt nauw samen met Production, QC, QP’s en operationele teams om kwaliteit en compliance te waarborgen, onderzoeken te ondersteunen en productiedocumentatie te reviewen. Dit is een hands-on QA-functie met regelmatige aanwezigheid op de shopfloor binnen Grade A/B cleanroomomgevingen, waarbij je optreedt als praktische kwaliteitspartner en bijdraagt aan het handhaven van hoge kwaliteits- en compliancestandaarden.
Belangrijkste verantwoordelijkheden
- Reviewen en goedkeuren van productiedocumentatie, SOP’s, protocollen en werkinstructies
- Ondersteunen en goedkeuren van deviations, investigations, CAPA’s en Environmental Monitoring beoordelingen
- Uitvoeren van witness-programma’s tijdens routineproductie en media simulaties
- QA-ondersteuning bieden binnen steriele en aseptische productieomgevingen
- Ondersteunen van root cause investigations van productieafwijkingen
- Ondersteunen van GMP-compliance activiteiten, inspecties en producttransfers
- Nauw samenwerken met Production, QC en operationele teams
- Actief aanwezig zijn op de shopfloor en binnen cleanroomomgevingen
Vereisten
- HBO- of WO-diploma in Biologie, Chemie, Farmacie of vergelijkbare richting
- Ervaring als QA Officer binnen een GMP-gereguleerde farmaceutische omgeving
- Sterke ervaring met deviations, investigations, CAPA’s en documentreview
- Ervaring binnen steriele of aseptische productieomgevingen is sterk gewenst
- Kennis van Environmental Monitoring en cleanroomprocessen is een pré
- Ervaring met IQ/OQ/PQ en validatieactiviteiten is een voordeel
- Vloeiende beheersing van Nederlands en Engels is vereist
- Hands-on, proactief, nauwkeurig en zelfstandig kunnen werken
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