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Quality Assurance Consultant
5 days ago
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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