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Quality Assurance Validation Engineer

  1. Belgium, Antwerp
Geel
  1. Permanent
Competitive
  1. Compliance / Quality Assurance
37086
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Quality Assurance Validation Engineer - Belgium, Geel - Permanent Contract

We are looking for an experienced Quality Assurance Validation Engineer on a Permanent basis for a client based not far from Geel (only 20 minutes from actual location), Belgium.

You will be working with our client who are a radiopharmaceutical organisation committed to improving the lives of people affected by cancer with their world first treatment which cannot be found naturally. Their focus is in the radiotheranostics field, which facilitates patient-tailored optimisation of treatment by tracking the distribution of therapeutic agents in the body. This cutting-edge approach minimises patient side-effects while enhancing treatment efficacy.


Responsibilities include:
  • Support creation and document qualification and validation documents including protocols, master plans, …
  • Support validation lifecycle activities, including risk assessments, test plan creation, execution, and summary reporting
  • Experience in drafting and approving validation protocols URS, IQ, OQ, PQ, VMP, FAT/SAT, VMP etc
  • Review and approve validation protocols and reports to ensure completeness and accuracy
  • Develop and maintain SOPs related to qualification and validation activities
  • Assist in audit preparation and participate in internal audits as needed.
  • Work closely with engineering, manufacturing, and R&D teams to ensure proper qualification of equipment
  • Provide QA oversight for validation activities conducted by third party vendors or contractors
  • Train and guide team members on validation processes
  • Act as a backup for other QA team members, providing support during absences or peak workload periods
  • Stay familiar with broader QA functions to ensure smooth operations across the Quality department.
Requirements:
  • Bachelor degree in Life Sciences, Chemistry, Engineering, or a related field
  • Requires extensive experience in a quality assurance and validation role in the pharmaceutical, industry.
  • Strong understanding of validation principles, regulatory requirements, and quality systems.
  • Experience with software validation (CSV) is a plus
  • Knowledge of risk management tools and methodologies (e.g. FMEA etc)
  • Excellent organisational skills
  • Excellent attention to detail and analytical skills.
  • Strong written and verbal communication skills.
  • Ability to work independently in a collaborative team environment.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Quick learner and able to work in a fast-changing environment
  • Willingness to work in a controlled environment with adherence to strict safety and regulatory protocols.
  • Language skills: English mandatory, Fluent in Dutch would be highly desirable
This is a superb opportunity if you are looking for a long-term opportunity in the field with a supportive and innovative company that will put you first.

If this role is of interest, please apply now!
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