Job description
Take your career to the next level with Amaris Consulting as a QA Qualification/Validation Consultant
Become part of an international team, active in a global group with €800M turnover and 1,000+ clients worldwide, and thrive in an agile environment where you help plan kickoffs and follow up on high-impact projects. Join Amaris Consulting, where you can develop your full potential and make a difference within the company.
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✍️ WHAT WOULD YOU NEED?
* Proven experience in the pharmaceutical or chemical industry, with a strong focus on qualification and validation activities
* Solid knowledge of cGMP regulations and guidelines (e.g., FDA 21 CFR Part 11, EU GMP, Annex 11)
* Hands-on expertise in one or more of the following domains:
o Manufacturing Systems Qualification
o Laboratory Systems Qualification (e.g., LIMS, CDS)
o Facility & Utility Systems (HVAC, water systems, cleanrooms)
o IT/Automation & Computer System Validation (CSV)
* Familiarity with validation lifecycle processes: URS, Risk Assessments, DQ/IQ/OQ/PQ, Change Control, CAPA
* Experience with industry-standard tools such as:
o Quality systems: Trackwise, Comet
o Document management: TruVault, Veeva, SharePoint
o Validation execution platforms: Kneat, ValGenesis
* Strong ability to translate technical information into clear, compliant documentation
* Excellent organizational, communication, and multitasking skills
* Capacity to work independently and collaboratively within cross-functional teams
* Fluent in English and Dutch (both written and spoken) – mandatory
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👉 WHAT WILL YOU DO? 👈
* Review and approve critical qualification and validation documents, including SOPs, User Requirements, Test Protocols, Change Controls, and CAPAs
* Ensure compliance with regulatory standards and internal quality policies throughout system lifecycles
* Support engineering teams during the implementation and upgrade of GxP systems and processes
* Provide QA guidance and cGMP oversight during qualification projects
* Investigate and follow up on deviations arising during validation execution
* Monitor and communicate project status related to quality, compliance, and timelines
* Collaborate with multidisciplinary teams to ensure smooth, compliant project delivery
* Contribute to continuous improvement of validation processes and quality systems
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🚀 WHY US? 🚀
Join our dynamic team of talented individuals and experience a world of growth and opportunities.
Here’s what we offer:
* Grow rapidly with a tailored career path and regular salary evaluations — 70% of our senior leaders started at entry level
* Enhance your skills through our Tech Academy, Udemy for Business, language sessions, webinars, and technical workshops
* Take charge of your development with an annual personal training budget and company-paid certifications
* Enjoy flexible working policies, including remote work options
* Benefit from comprehensive social perks: transit & restaurant tickets, kindergarten support, private health insurance
* Rely on our WeCare program, offering support during personal or professional challenges
* Work in an inclusive, diverse, and equal-opportunity environment — we welcome all qualified candidates regardless of gender, sexual orientation, race, ethnicity, age, disability, or background
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Unleash your full potential — both professionally and personally.
Amaris Consulting is proud to be an equal-opportunity employer. We are committed to fostering diversity and creating an inclusive workplace where every voice matters.
👉 Apply today and become part of a global success story!