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Staff Engineer QA NPI & R&D

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Staff Engineer QA NPI & R&D

Locations: Geel, Belgium
Functions: Quality (Eng)
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Job Description

Requisition ID: 1905766616W

JSC - Staff Ingenieur QA NPI & R&D

Afdeling Chemische Kaliteitsbeheersing - GEEL

Omschrijving

Ongeveer 600 medewerkers van Janssen Pharmaceutica zijn werkzaam in onze chemische vestiging in Geel. Hier worden op grote schaal geneeskrachtige stoffen aangemaakt, de actieve bestanddelen van een geneesmiddel die door de farmaceutische productie verwerkt worden in de uiteindelijke toedieningsvorm zoals tabletten, ampullen, zalven en anderen. Chemische Productie Geel legt zichzelf consequent strenge kwaliteitsnormen op, zowel voor producten als werkmethodes . Werken in een veilige, gezonde en milieuvriendelijke omgeving en voldoen aan alle wettelijke vereisten staan dan ook hoog in ons vaandel.

Binnen de afdeling Chemische kwaliteitsdiensten is er een vacature voor een positie van Staff Ingenieur QA NPI & R&D.

Uw Funktie

De functiehouder is verantwoordelijk voor alle kwaliteitsaspecten gelinkt aan de hem/haar toegewezen R&D/NPI producten:
* Opvolging/uitvoering van projecten i.f.v. nieuwe productintroducties inclusief review/goedkeuring van protocollen en rapporten voor analytische methodetransfers en procesvalidaties, review/ goedkeuring van procescriticaliteitsanalyses en synthese- criticaliteitsanalyses, review/goedkeuring van master batch records
* Het bijdragen aan en finaal goedkeuren van onderzoeken gelinkt aan de toegewezen processen en bewaken dat ernstige afwijkingen tijdig geëscaleerd of geconsulteerd worden binnen de organizatie in lijn met de geldende procedures
* Vrijgave grondstoffen, intermediates and API's geproduceerd in Chemische Productie België voor commerciële NPI's
* Vrijgave van klinische API batchen geproduceerd binnen de ontwikkelingsorganisatie (PDMS)
* Dagdagelijkse plant support voor BU CDMP/CDPP
* Uitvoeren van QA controlerondgangen in BU CDMP/CDPP
* Het bijdragen aan en finaal goedkeuren van onderzoeken gelinkt aan BU CDMP/CDPP
* Goedkeuring van procedures en werkinstructies van toepassing met betrekking tot de eigen expertise.
* Het continue evalueren van mogelijkheden tot verbetering van werkprocessen ifv kwaliteit, veiligheid, en kost.
* De uitvoering van projecten in het kader van verbeteringsinitiatieven binnen de kwaliteitsafdeling
* Opnemen van proceseigenaarschap voor toegewezen processen
* Het behandelen van klachten gelinkt aan de productkwaliteit
* Input en review van product quality review rapporten (PQR) en proactive product quality scans (PPQS)s voor nieuwe product introducties
* Review en goedkeuring van CPV rapporten voor NPI's
* Het leiden of deelnemen aan interne audits, rapport schrijven en identificeren van noodzakelijke CAPA's

Als lokale expert en aanspreekpersoon zal u in een globaal end-to-end quality team borgen dat onze producten/processen voldoen aan de cGMP verwachtingen en op succesvolle wijze een pre-approval of algemene inspectie doorstaan.

Qualifications
Kwalificaties:
* U bezit een wetenschappelijk diploma van universitair niveau met scheikundige of procestechnologische basis (of gelijkwaardig door ervaring) of u beschikt over een diploma industrie-apotheker,
* U hebt kennis en ervaring met cGMP binnen chemische of pharmaceutische omgeving, kennis rond specifieke cGMP vereisten voor de productie van clinical trials material is een pluspunt
* U heeft uitgesproken interesse voor chemische synthese, procestechnologie en analytiek (organische/analytische scheikunde)
* U bent stressbestendig en kan zelfstandig en projectmatig werken binnen uitdagende tijdslijnen
* U werkt nauwgezet, bent analytisch ingesteld en zoekt proactief naar oplossingen
* U kan uw gebalanceerde kwaliteitsbeslissing op een heldere manier motiveren en documenteren en bent pragmatisch ingesteld
* U bent flexibel ingesteld en kan samenwerken binnen de context van lokale en globale NPI en quality teams
* U beschikt over de nodige overtuigingskracht en communicatieve vaardigheden
* U spreekt en schrijft vloeiend Engels

Primary Location
Belgium-Antwerp-Geel-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality (Eng)
Requisition ID
1905766616W
Office of Strategy and Growth
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters

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This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. Contact Us with any questions or search this site for more information.
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Staff Engineer QA NPI & R&D

Permanent contract
R&D Engineer, Engineer