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Quality Assurance Specialist

1 week ago

Stockholm, Stockholm, Sweden Ingenjörsjobb Full time
About the Role

We are seeking a highly skilled Validation Engineer to join our Life Sciences team in the greater Stockholm-region.

This is an exciting opportunity for a motivated individual to work with different customers in the pharmaceutical industry, supporting them in their product development chains.

Key Responsibilities:

  • Lead, plan, coordinate and/or perform validation and qualification activities
  • Perform qualification and validation testing 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
Requirements
  • Bachelor's degree in a relevant science/technical field; e.g. Pharmacy, Biology, Chemistry or Engineering
  • At least 2 years of experience with validation and/or qualification within the pharmaceutical industry
  • Demonstrated knowledge in GxP
  • Able to work independently under own initiative
  • Good communication and presentation skills
  • Fluent in Swedish and English in both written and spoken form