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QA specialist

External
gehc logoGehc · Oslo, Norway
Full-timeOn-site3d ago
ComplianceDocumentationSAP
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Requirements

  • Batchlor or master's degree in pharmacy or equivalent
  • Experian's from pharmaceutical industry
  • Experience from GMP work.
  • Know your way around Office programs.
  • SAP, Veeva, Trackwise, Digital , LIMs.
  • Solution oriented - the favorable candidate is one who identifies a problem, identifies and propose solutions, finds the relevant facts before asking for presenting and asking for assistance.
  • Structured - enjoys setting goals, timelines and achieving them promptly.
  • Positive - An attitude that invites collaboration and makes the process of achieving difficult/complex tasks, enjoyable.
  • Social - ability to interact with others regardless of ethnicity, religion, gender, political views, or personal world view.
  • Enjoys working with experts from other fields including Quality Control analysis, Manufacturing, Packaging, Research & Development, Regulatory affairs, Artwork Management, Suppliers and Authorities around the world.
  • Team members including leader - 18.
  • Gender distribution - 17 female and 1 male
  • Age distribution - 29 - 67 years
  • Average education - master's degree in pharmacy
  • Experience in GE - 1-30 years
  • Common behavioral attributes- Analytical, Social, Integrity, High work capacity, Service oriented, High delivery.
  • Work environment in the department is generally at a high pace.
  • QP release of products to the market. I addition a range of activities from drug development, upscaled production, technical transfers, to manufacturing and product discontinuation. The Correct candidate to this position will work together with the QPs
  • It is a temporary position (Maternity leave) but might be a permanent position. It is not possible to say at the present time It depends on the qualification and the business need.
  • Additional Information
  • Relocation Assistance Provided: No

Additional Information

Job Description Summary Quality specialist. Main task: Handling of deviations and CAPAs Complaint handling Product Quality review (author) SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc. Compliance Wire reseponsible person Support projects. Participate in problem solving and be a professional support for the plant and departement. Batch documentation (support to QP, follow up against department) Job Description Department QA DABR Main tasks: Handling of deviations and CAPAs Complaint handling Product Quality review (author) SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc. Compliance Wire reseponsible person Support projects. Participate in problem solving and be a professional support for the plant and departement. Batch documentation (support to QP, follow up against department)


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