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Job ID :
65999BR
Location :
Netherlands - Tilburg
:
Job Description
The Junior Quality Assurance Officer ensures that cGMP manufacturing activities on the floor, are completed in accordance with cGMP requirements (e.g. good documentation practices), adhere to the approved Standard Operating Procedures, are consistent with emerging/existing corporate & regulatory guidelines as necessary and are continuously improved through leveraging the Quality Systems architecture and execution by the organization, assuring product quality.
  • Direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices.
  • Advise, facilitate, and support all phases of manufacturing batch documentation development.
  • Quality review and approval of cGMP documentation.
  • Application of cGMP change control.
  • Release or reject finished products safeguarding public health and compliance after review of production documentation, QC documentation and considering all relevant factors.
  • Understanding of the connection between floor documentation and the batch disposition process.
  • Execute the Quality management systems according to the corresponding and approved policy.
  • Work with complex and comprehensive electronic databases (e.g. Trackwise) to document events related to product quality.
  • Evaluate the performance of systems and processes.
  • Initiate corrective or preventive actions if there are system or process defects.
  • Support regulatory inspections from readiness exercises and internal audits.
  • Implement new information in practice.
  • Alignment of Standard Operating Procedures, documentation practices, and efficient documentation flows in the Quality release.
  • Pro-actively seek information of (Sr) QA Officers to stay up to date.
Qualifications
  • Bachelor degree, with a pharmaceutical, chemical, nutritional or other relevant training.
  • At least 1 year relevant experience in the pharmaceutical- or food industry
  • Experience with quality management systems, like HACCP, GMP
  • Experience with software, under which Word, Excel, PowerPoint and Access
  • Able and willing to work in a 5 shifts-structure.
  • Fluent in Dutch and English.


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