Validation Engineer CSV
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
- en regelgevende vereisten en bewaakt hun gevalideerde status gedurende de volledige levenscyclus. Verantwoordelijkheden
- Opstellen, implementeren en uitvoeren van URS, SIA, DQ, IQ, OQ, PQ, RV en TM-activiteiten.
- Uitwerken en uitvoeren van validatiestudies voor cGMP-kritische software en computerized systems.
- Schrijven en beheren van validatiedocumentatie, waaronder protocollen en rapporten.
- Ondersteunen bij de uitvoering van validatieprotocollen en troubleshooting van validatieproblemen.
- Evalueren van wijzigingen en impact op de gevalideerde status van systemen.
- Zorgen voor naleving van cGMP, cGLP, FDA-, EU
- en interne kwaliteitsrichtlijnen.
- Actief bijdragen aan projecten volgens de geldende kwaliteits
- en compliancevereisten. Kwalificaties
- Bachelor of master in een biowetenschappelijke richting.
- Minimaal 3 jaar ervaring in de farmaceutische sector binnen een GMP-omgeving. Vereiste Vaardigheden
- Sterke kennis van Computer Systems Validation (CSV).
- Ervaring met validatie van softwarepakketten en geautomatiseerde systemen.
- Goede kennis van relevante kwaliteits
- en compliancevereisten.
- Sterke communicatieve vaardigheden.
- Zelfstandig, leergierig en oplossingsgericht.
- Vlotte beheersing van Nederlands en Engels. Vergoeding en Compensatiepakket
- Vast contract vanaf dag één.
- Brutosalaris tussen €2.350 en €3.250, afhankelijk van ervaring.
- Aantrekkelijk voordelenpakket.
- Premium bedrijfswagen met tank
- of laadkaart.
- Groeps
- en hospitalisatieverzekering.
- Maaltijdcheques (€8/dag) en ecocheques (€250/jaar).
- 12 ADV-dagen.
- Opleidingen, doorgroeimogelijkheden en persoonlijke begeleiding door een Career Manager. Gelijke Kansen Verklaring Wij zijn toegewijd aan diversiteit en inclusiviteit. Iedereen krijgt bij ons dezelfde kansen om te schitteren.
-
Validation Engineer CSV
Il y a 3 semaines
Geel, Flemish Region, VLG, Belgique Amaris Consulting Télétravail Temps plein**Job Description** As a Validation Engineer – Computerized Systems, you will be responsible for planning, executing and maintaining validation activities for cGMP‑critical software packages and computerized systems. You will ensure systems remain in a validated state, compliant with cGMP, regulatory expectations and internal procedures, directly...
-
ADAS Performance
Il y a 3 semaines
Zaventem, Flemish Region, VLG, Belgique Toyota Motor Europe Télétravail Temps plein**In a nutshell** Boost ADAS validation by virtualizing real-world driving on HiL benches—optimize camera-based system performance, automate testing, and accelerate next-gen safety innovation. **Company Information** Toyota is one of the world’s largest automobile manufacturers and a leading global company, founded in 1937. Today, Toyota sells...
-
MES Engineer CAR-T
Il y a 3 semaines
Ghent, Flemish Region, VLG, Belgique Johnson & Johnson Innovative Medicine Temps pleinAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Project Engineer HVAC
Il y a 3 semaines
Antwerp, Flemish Region, VLG, Belgique Akkodis Temps plein🌟 **Who we are** Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to...
-
Mechanical Design Engineer
Il y a 3 semaines
Izegem, Flemish Region, VLG, Belgique Televic Healthcare Temps pleinTelevic Healthcare develops, manufactures and markets nurse call systems for hospitals and nursing homes internationally. Our products are used by tens of thousands of patients daily, as well as by the nurses taking care of them. Our device portfolio consists of wall-mounted, wearable and hand-held units, with and without screens, with and without audio...
-
Quality Assurance Automation Engineer
Il y a 3 semaines
Antwerp, Flemish Region, VLG, Belgique TiTANS Consulting | TiTANS Recruitment | TiTANS Werving & Selectie | TiTANS Interim Management Temps pleinAs a Medior QA Engineer, you are responsible for ensuring the quality of our digital platforms, APIs, and cloud-based applications. You work closely with business analysts, product owners, software developers, and operational stakeholders to ensure that new functionalities meet both functional and non-functional requirements. You take an active role in the...
-
MSAT process engineer
Il y a 3 semaines
Antwerp, Flemish Region, VLG, Belgique Akkodis Temps plein🌟 **Wie zijn wij?** Akkodis is een wereldwijde leider in digitale engineering en slimme industrieën, waar talent en technologie samenkomen om een slimmere toekomst vorm te geven. Met meer dan 50.000 experts wereldwijd en meer dan 1.000 medewerkers in België ondersteunen we bedrijven uit diverse sectoren op vlak van innovatie, digitale transformatie en...
-
Senior Performance-Resilience Test Engineer
Il y a 3 semaines
Zaventem, Flemish Region, VLG, Belgique ARHS Group Télétravail Temps pleinArηs Group, Part of Accenture, specializes in the management of complex public sector IT projects, including systems integration, informatics and analytics, solution implementation and program management. Our team helps lead clients through digital and information systems design, bringing expertise in a variety of areas ranging from software development,...
-
Embedded Security Software Engineer
Il y a 3 semaines
Zaventem, Flemish Region, VLG, Belgique STMicroelectronics Temps plein**OUR STORY** **At STMicroelectronics, we believe in the power of technology to drive innovation and make a positive impact on people, businesses, and society. As a global semiconductor company, our advanced technologies and chips form the hidden foundation of the world we live in today.** **When you join ST, you will be part of a global business with more...
-
Project Engineer Master Batch Records
Il y a 3 semaines
Antwerp, Flemish Region, VLG, Belgique Akkodis Temps plein🌟 Who we are Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end...
