Qualification Engineer – Belgium

Introduction

Q-People provides targeted solutions in Quality and Compliance projects within Life Sciences, from Pharmaceutical and Biotech to API and Medical Device Production. Training, mentoring and coaching of talent within the Life Sciences sector is our strength. We don’t want specialist knowledge or talent to go to waste. WE PUT PEOPLE FIRST!

Our expert are active in:
1. Validation or qualification
2. Process engineering
3. Product development
4. Quality control projects
5. Quality assurance projects (analyst, project engineers)
6. Project Management in general

Organization

Q-People

Function

Your role will vary according to the project and your level of expertise. Overall, you are likely to have the following responsibilities;
• In dialogue with the client, you will develop the validation strategy (VMP) and validation plans in accordance with the quality standards.
• You will manage the commissioning in the different phases (start-up, qualification…) in compliance with the contractual conditions and the customers’ requirements.
• You will define the qualification approach.
• You will establish the qualification procedures in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP).
• You will write the qualification documents.
• You will perform FAT/SAT and commissioning of equipment.
• You will coordinate and execute qualification tests (IQ, OQ).
• You will work closely with production, EHS, engineering, maintenance, QC, QA…
• You will ensure the handover to the end users.
• You will initiate, execute and supervise the validation operations of the packages entrusted to you.
• You will operate the verification and documentary approval during the project.

Requirements

• Master in engineering (mechanical, electromechanical, automation, electrical, chemical or biochemical…)
• Proven experience on Qualification/Validation projects in a GMP environment.
• At least 2 years of relevant experience in the field of commissioning and qualification.
• Fluent in French or Dutch AND English.

Offer

– The opportunity to co-create the Q-People strategy;
– A career plan and an individual coaching;
– Challenges related to your expertise and ambition ;
– Being part of our community of Q-Consultants and benefit from advice and support from peers;
– Funny moments: team buildings, afterworks, events, etc. ;
– Our Q-Academy offers an broad training programme (hard&soft skills) to strengthen your knowledge and develop your skills;
– A permanent contract and an attractive salary package (13th month pay, hybrid car, petrol card, net allowance, meal vouchers, group insurance, hospital insurance, etc.).

Application

Ana Pardo Pons | Talent Partner
[email protected]
Place de l’Université 16 | Louvain-la-Neuve

 

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