Junior Qualification Pharmaceuticals F M X

Job Description

Purpose of the Role:

You ensure that equipment and computerized systems used in pharmaceutical manufacturing are properly specified, installed, qualified and maintained in a validated state throughout their life-cycle. From project kick-off to decommissioning, you provide the technical and regulatory backbone that guarantees every system performs exactly as intended, meeting user requirements, cGMP and company standards.

Core Responsibilities

• Qualification & Validation Lifecycle
• Draft, review and execute qualification documents: URS, Risk Assessments, Design Qualification (DQ), FAT/SAT, IQ/OQ/PQ protocols & reports.
• Develop validation strategies and master plans for new or modified equipment/systems.
• Investigate and resolve deviations, CAPAs and change controls linked to qualification activities.
• Maintain validated state via periodic reviews and continuous improvement initiatives.
• Project & Stakeholder Support
• Act as qualification lead on CAPEX projects, translating regulatory and user requirements into technical specifications.
• Provide timely, quality-compliant support to internal customers (Engineering, Production, QA, QC) and external auditors.
• Update the Site Validation Masterplan and associated equipment listings.
• Quality, Safety & Compliance
• Embed evolving regulatory requirements (FDA, EMA, Annex 15, GAMP 5) into SOPs and work instructions.
• Ensure data integrity and electronic-record security.
• Maintain personal training status and adhere to HSE guidelines.
• Track KPIs and metrics to demonstrate qualification performance.
• Supplier & Sub-contractor Oversight
• Coordinate and supervise qualification activities performed by third parties.
  
  

Required Profile

Experience: 1–3 years in equipment or system qualification within a GMP-regulated environment (pharma, biotech, medical devices).

Technical Skills

• Hands-on knowledge of validation lifecycle (DQ–IQ–OQ–PQ).
• Familiarity with risk assessment tools (FMEA, HACCP).
• Good command of cGMP, GAMP 5, 21 CFR Part 11.
• Proficient in MS Office and validation documentation systems (e.g., Veeva, TrackWise).
  
  

Soft Skills

• Detail-oriented, analytical mindset.
• Strong written and verbal communication in French and English mandatory
• Ability to manage multiple projects and priorities in a fast-paced environment.
  
  

Education: Degree in Engineering, Pharmacy, Life Sciences or equivalent.

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.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

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.

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. Heres 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 candidates shoes to ensure they have the best possible experience.

We look forward to meeting you!

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