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The Quality Assurance (QA) Specialist for QA systems is responsible for the maintenance, quality review and approval of investigations in Trackwise according to regulatory requirements, Fisher Clinical Services Standard Operating Procedures (SOPs) and Work Instructions.
- Perform maintenance, quality review and approvals for Trackwise investigations
- Coordination and internal communication regarding the scheduling and completion of the investigation reviews and approvals
- Support improvement of quality metrics by analyzing data
- Subject Matter Expert for for Trackwise activities
- Perform Effectiveness Checks of CAPAs
- Participate in Practical Process Improvement and other projects
- Provide support for the larger Quality department as needed
Non-negotiable Hiring Criteria:
- GxP training or experience
- B2 or higher level in German and English (reading and writing)
- Demonstrated ability to perform detail-oriented tasks
Education & Experience:
- Bachelor's degree in science or equivalent, or GxP training, or previous experience in a pharmaceutical industry, quality, medication handling or scientific role
Skills:
- Excellent written and oral communication skills
- Excellent organizational skills
- High level of accuracy
- Ability to express detail in simple terminology
- Written and oral command of English and German at professional level
- Able to work under tight timelines
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