Consultant Process

il y a 11 heures

België Nederland Belgium Agidens Temps plein

At Agidens, we combine technical expertise with practical solutions to optimize processes and meet the highest quality standards. Our focus is on innovation, quality and patient safety.
To strengthen our growing team, we are looking for a driven Subject Matter Experts in the areas of Cleaning Valid...

At Agidens, we combine technical expertise with practical solutions to optimize processes and meet the highest quality standards. Our focus is on innovation, quality and patient safety.

To strengthen our growing team, we are looking for a driven Subject Matter Experts in the areas of Cleaning Validation and/or Process Validation.

Depending on your specialization, you will take on a crucial role in projects using your expertise to meet the most strict regulations. From your role as SME, you will also support our growth by training junior colleagues and strengthening the sales team in acquiring new projects.

What will you do?

Within cleaning validation you will be responsible in the preparation of the complete validation master plan. In the day-to-day operation you will assist the project team and the customer in setting up system specific protocols and planning the daily executions.

Within process validation, you will work with the client to map out the validation schedule and provide all quality documentation. You will provide an overview of all critical process steps and process parameters that will be monitored during validation. You are responsible for preparing the sampling plan. You supervise your project team and the customer throughout the project.

Who are you?

Bachelor -or Master degree in biotechnology, pharmacy, chemistry or a technical field.
Minimum of 3 years of experience in process and/or cleaning validation.
Knowledge of cGMP, EMA and FDA regulations.
Knowledge of the 'quality by design' principle.
You get energy from training and supervising a project team. You are a real motivator.
You have strong communication skills and the ability to explain complex subjects clearly.
Fluent in Dutch and English.
Strong analytical skills and an eye for detail.

What's in it for you?

A challenging position in a technology driven organization - as a subject matter expert you will work on the most complex projects.
A strong team culture based on trust and ownership
Stay connected through regular team meetings and teambuildings
Competitive salary package with extra-legal benefits such as a company car + fuel card/charge card, net allowance, iPhone, laptop, meal vouchers, eco vouchers, etc.
Optimal work-life balance is important at Agidens. Therefore, we offer 36 vacation days with the possibility of working from home.

Let's get together

Does this sound like the opportunity for you? Apply now or send your questions to Blima van Daele via blima.vandaele@agidens.com or +32 484 85 65 52.

Salaire estimé

35.840 € - 60.480 € /an

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