Junior CSV Manager

Amaris
Brussel, Belgium
3 months ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Starter
Experience required
3 years minimum
Working hours
Regular working hours
Languages
English, French
Job source

Tech stack

System Testing Test Execution Engine GXP

Job description

Amaris Consulting is looking for a motivated Junior CSV (Computer System Validation) Manager with 3 to 5 years of experience to join our dynamic team in Brussels within an international pharmaceutical environment. In this role, you will contribute to Computer System Validation activities and support compliance initiatives for regulated systems while gaining hands-on experience in a collaborative and fast-paced environment., Support Computer System Validation activities for regulated pharmaceutical systems and applications Participate in validation lifecycle activities including risk assessments, test execution, and documentation review Prepare and maintain validation deliverables such as validation plans, protocols, reports, and traceability matrices Collaborate with QA, IT, Business, and project teams to ensure compliance with GxP requirements Support change controls, deviations, CAPAs, and audit preparation activities Contribute to ensuring compliance with regulations such as GAMP5, FDA 21 CFR Part 11, and Annex 11 Assist in system implementation, upgrades, and validation projects Participate in continuous improvement initiatives related to validation processes and quality standards, At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience. We look forward to meeting you!

Requirements

Do you have experience in GxP?, Do you have a Master’s degree?, Bachelor’s or Master’s degree in IT, Engineering, Life Sciences, or a related field 3 to 5 years of experience in Computer System Validation within the pharmaceutical industry Good understanding of GxP environments and validation methodologies Experience with validation documentation, testing activities, and regulated systems Fluent in English and French, both written and spoken Strong analytical, communication, and organizational skills Ability to work in cross-functional and international environments Motivated, detail-oriented, and eager to develop expertise in validation and compliance

About the company

Why Join Amaris Consulting?

Agility: Work in a dynamic, flexible, and stimulating environment. International exposure: Collaborate with teams in over 60 countries and enjoy mobility opportunities. Intrapreneurship: Take ownership of your ideas or create your own Business Unit. Supportive management: Your manager will guide you based on your individual profile and goals., Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

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