Our client, a leading pharmaceutical organization, is seeking a professional to support their quality engineering department in ensuring that all qualification requirements are met throughout the manufacturing system lifecycle. This role focuses on maintaining compliance with regulatory standards during the concept, project, and operational phases of production systems.
Review and approve qualification documents including SOPs, user requirements, and risk analyses to maintain regulatory compliance.
Review quality records such as test plans, test scripts, Change Controls, and CAPAs.
Participate in engineering teams to provide cGMP guidance for the introduction of new or upgraded systems and processes.
Manage and follow up on deviations occurring during the execution of qualification activities.
Communicate status updates regarding quality, compliance, and planning to the broader quality assurance team.
You possess a background in the chemical or pharmaceutical industry with specific experience in equipment qualification.
You bring sound knowledge of cGMP regulations and guidelines.
You have experience with manufacturing systems and document management tools such as TruVault.
You have worked with problem reporting and change request systems such as Trackwise or Comet.
You are able to translate technical information for various organizational levels and manage multiple projects simultaneously.
You are fluent in English and Dutch.
Nice to Haves
Experience with digital test tools such as Kneat.