20 beste vacatures voor de functie van specialist in haaften, ge (nieuwe medewerkers gezocht)

Quality Assurance Computerized Systems Validation Specialist
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Quality Assurance Computerized Systems Validation Specialist

Ardena -
Oss

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Vacaturegegevens

Secundaire arbeidsvoorwaarden

Flexibele werkuren

Kwalificaties

Engels
Analytisch vermogen
Projectmanagement
Kwaliteitsborging
Bachelor
Scheikunde
ICT
AI
Communicatieve vaardigheden

Volledige vacaturetekst

Introduction to Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 700 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

For the Ardena Corporate IT department we are looking for a

Quality Assurance Computerized Systems Validation (QA CSV) Specialist

We are looking for a skilled and motivated professional eager to further their careers in an exciting and fast-paced environment.

WHAT YOU WILL WORK ON

Within our fast-growing environment, we are continuously striving for an optimal level of processes and automation. In this specific role, you will be responsible for providing QA oversight of corporate GxP computerized systems.

YOUR KEY RESPONSIBILITIES

You contribute to strengthening the Quality posture of Ardena’s Corporate IT department, from both a technical and procedural perspective.
Interpret relevant rules and regulations for both EU and US compliance, including remaining up to date with them.

You will draw up and champion validation deliverables, e.g. project plans and validation documents according to international GxP standards.

You take part in setting up and documenting a risk-based validation strategy.

You draft and review procedures.

You are jointly responsible for determining the impact of changes.

You will be performing critical reviews of deviations and CAPA.

You will closely work together with colleagues from the QA departments, the IT department, validation engineers and others across different departments depending on the project.

YOUR PROFILE LOOKS LIKE/ RESEMBLES

Bachelor’s degree in a scientific direction (Chemistry, Chemical Engineering, Biotechnology, Pharmacy, IT)
At least 5 years’ QA and GxP validation experience in the pharmaceutical industry
Advise and solve validation problems related to projects, process development, risk mitigation, etc.
Project management experience is beneficial
Comfortable in a dynamic and changing environment
Eagerness to learn and develop yourself
Flexible, a problem solver and a team player
Accurate and an analytical mindset
Interest in AI
Excellent communication skills English (written as well as spoken)
Dutch and Spanish are beneficial
Willing and able to travel to several locations to support and work with the local teams. (Travel 20% of the time)

WHAT WE OFFER

A competitive salary
Flexible working hours
Hybrid working
A dynamic, international work environment with career growth opportunities
Access to Ardena Academy, our internal learning platform for professional development
A chance to contribute to groundbreaking drug development projects that make a real impact

HOW TO APPLY

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

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Verfijn je zoekopdracht

specialist vacatures in haaften, ge

Quality Assurance Computerized Systems Validation Specialist

Senior Specialist Anti Financial Crime (AFC)

Safety Specialist

Risk Specialist

Integration Specialist

Masterdata Specialist

Logistics specialist

L&D Specialist

SENIOR FINANCIAL ADMINISTRATION SPECIALIST (HQ NETHERLANDS)

Sales Support Specialist

Environmental Health and Safety Specialist

Employer branding specialist

EHS Specialist NL

Fusie & Overname Specialist

Renewal Specialist

Digital Marketing Specialist (Social Advertising)

Apache Camel Specialist

Business Information Specialist

CRO Specialist

Inside Sales Specialist

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van specialist in haaften, ge

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