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Imke De Hert

Experienced Risk and Compliance consultant

Regulatory Compliance | Belgium


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CTG Belgium is looking for experienced Risk & Compliance Consultants for various projects in the Life Sciences sector.

In order to guarantee patient safety, numerous regulations apply within Life Sciences. As a Risk & Compliance consultant, you help ensuring patient safety and quality. Our consultants usually work on compliance projects within IT, but are also active in other departments and/or in an operational role. The combination of scientific knowledge and interest/experience in IT and automation within the Life Sciences sector defines the unique character of our unit and consultants.


Job description

As a Risk and Compliance consultant, you are responsible for the planning, coordination, implementation and reporting of projects in the fields of Computer System Validation (CSV), QA/QC and/or IT-related compliance. You also act as mentor and coach for your junior colleagues.

You create high quality documentation, write procedures and offer support to end users.

You carry out assessments, gap and risk analyses and draw up improvement plans. You are creative in finding solutions to complex client issues and can rely on at least 3 years of experience and expertise.


Profile

You have a Master of Science ((bio)chemistry, pharmacy, biomedical sciences, bioengineering) or equivalent through experience. You have at least 3 years of experience in compliance within regulated industries.

You have a good knowledge of the applicable laws and regulations, industry standards and guidelines (GxP, 21 CFR Part 11, GAMP....). Knowledge of ISO standards (9001, 27001) is a plus. You are proficient in MS Office.

You have a strong work ethic and are flexible, pragmatic and accurate. Quality is an absolute priority for you.

Over the course of your career, you have gained experience in project management and have evolved as a strategic thinker with strong analytical and problem solving skills who can translate client needs into concrete and effective actions. You are a team player who is also able to work independently. You have excellent communication skills and write fluently in English and preferably Dutch or French.


Our offer

An interesting challenge with a company that has been nominated one of Belgium's "Best Employers" for many years in a row.

A motivating flexible salary package including a company car, meal allowance, representation allowance, group insurance and 34 days off.

A corporate culture characterized by open communication and exceptional care for our employees.


Interested?

Send us your CV and motivation letter and we will give you feedback on your application within one week.



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