QA Officer Compliance Process Reviewer
Geel, Belgium Temporary Date posted 24/06/2024QA Officer Compliance Process Reviewer
Location: Geel
About the job
Binnen de QA operations afdeling zijn we opzoek naar een QA compliance officer voor productie plant 2. In deze functie ben je verantwoordelijk voor quality ondersteuning van alle operationele activiteiten in de APU plant 2 organisatie.
Taken en verantwoordelijkheden:
Opvolgen, reviewen (en behandelen) van (major) QA events, CAPA’s en proceswijziginen (CCR’s). Opvolgen, reviewen en coördineren van general GMP, Quality operations en project documentatie (technical reports, PQR, risk assessments, batch records, ...).
Quality ondersteuning en beslissingen nemen in zake operationele kwaliteitsissues gerelateerd aan de manufacturing activiteiten alsook expertise delen met betrekking tot klinische en commerciële manufacturing.
Quality ondersteuning bieden bij procesvalidatie activiteiten.
Compliance zijn met SOP’s, globale standaarden, regulations en product registratie (filing) met betrekking klinische en commerciële manufacturing.
Aanspreekpunt voor regulatoire inspecteurs tijdens audits en inspecties.
Deelname aan APU/APT methodiek en cultuur (+QDCI, ...), en verbeteringsprojecten met focus op kritische activiteiten.
Uitvoeren van GEMBA (e.g. opvolgen van operationele activiteiten, projectwerken, shakedowns, ...).
About you
Master in een wetenschappelijke richting of gelijkwaardig door ervaring.
Kennis en interpretatie van cGMP in een gereguleerde omgeving.
Kennis en interpretatie van klinische manufacturing en regulations is een voordeel.
Uitmuntende nauwkeurigheid en oog voor detail, alsook zelfstandigheid en een sterk verantwoordelijkheidsgevoel.
Een enthousiaste teamplayer en sterk in communicatie.
Goede writing skills.
Goede kennis van de Engelse taal.
Why choose us?
Wil je deel uitmaken van een jong, dynamisch team, dat mee waakt over de kwaliteit van de producten die we produceren en graag meewerkt aan procesverbeteringen, dan ben jij de geknipte kandidaat die we zoeken.
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At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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Experience possibility
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