Quality Assurance Consultant

5 days ago


Stockholm, Stockholm, Sweden Ingenjörsjobb Full time
Job Description

We are seeking a highly skilled Quality Assurance Consultant to join our Life Sciences team in the greater Stockholm-region.

The ideal candidate will have experience with validation and/or qualification within the pharmaceutical industry and be able to demonstrate knowledge in GxP. They should also be fluent in Swedish and English in both written and speech.

  • Main Responsibilities:
  • Lead, plan, coordinate and/or perform validation and qualification
  • Perform qualification and validation test of equipment, process, method, system, and/or instruments
  • Issue and review validation plans, protocols and reports
  • Investigate deviations and follow up with CAPA
  • Define manufacturing processes, equipment, method, system, and/or instruments
  • Create or support the creation of URS
  • Define, write, review, update validation documentation, perform validation activities, such as validation assessments, validation plans, FAT&SAT protocols, IQOQPQ protocols and reports
  • Risk analysis and management
  • Initiate and manage change management operations


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