Job description
Are you interested in working at the intersection of IT, quality, and pharmaceutical regulations? Do you want to build expertise in Computer System Validation (CSV) while contributing to innovative projects in the life sciences industry?
Amaris Consulting is looking for a Junior CSV Consultant to support our teams and clients in ensuring compliance and quality of computerized systems within regulated environments.
Your Role
As a Junior CSV Consultant, you will help ensure that computerized systems comply with regulatory requirements throughout their entire lifecycle. You will collaborate with IT, engineering, and quality teams to implement and validate systems according to industry regulations.
Key responsibilities include:
* Ensuring Computer System Validation (CSV) activities meet regulatory requirements throughout the full system lifecycle (concept, project, operational, and retirement phases).
* Reviewing and approving CSV documentation such as SOPs, User Requirements, risk assessments, validation plans, test scripts, changes, and deviations.
* Supporting the development and continuous improvement of CSV processes and quality standards.
* Preparing for and supporting regulatory inspections and internal/external audits.
* Collaborating with IT, engineering, and quality teams for the introduction of new systems and processes.
* Providing guidance on cGMP compliance during new projects and validation activities.
* Staying up to date with international regulations, guidelines, and best practices related to CSV.
Your Profile
We are looking for a motivated professional with an interest in quality, compliance, and digital systems within the life sciences sector.
Requirements:
* Experience in CSV, Quality Assurance, or a regulated environment (preferably pharma)
* Knowledge of Computer System Validation principles and quality processes
* Experience with validation documentation (URS, risk assessments, validation plans, or test scripts)
* Strong communication skills and ability to work with cross-functional teams
* Good command of English and Dutch
Nice to have:
* Knowledge of GxP / cGMP regulations
* Experience with continuous validation or quality standards
Why joining us?
* Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
* Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
* International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.