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Quality Assurance Analyst, Qualification Facility & Utility at Clinchoice
ClinchoiceGeel, Belgium·21h ago
Mid LevelFull-timeRust
Salary Range
$102,850 - $139,150 /year
This salary is estimated based on similar roles. The actual salary may vary.
Key Responsibilities
- →Review and approve qualification documents and quality records such as SOPs, user requirements, impact/risks analysis, Test Plans, test scripts, change controls, CAPA, etc.
- →Interact with engineering teams and other groups for the introduction of new/upgraded systems and processes.
- →Address and follow up on deviations during qualification activities.
- →Communicate status regarding quality, compliance, and planning to QA Qualification team members.
Requirements
- ✓University/Bachelor’s Degree or Equivalent.
- ✓Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
- ✓Knowledge of cGMP regulations and guidelines.
- ✓Ability to translate technical information into understandable information for all organizational levels.
- ✓Capacity to estimate urgency, criticality, and impact of decisions related to the function.
- ✓Ability to multi-task and work on various projects simultaneously.
- ✓Ability to work independently and in a cross-functional team environment.
- ✓Good communication skills.
- ✓Fluent in English and Dutch (spoken and written).
- ✓Familiarity with Facility and Utility systems used within pharmaceutical or chemical industry.
- ✓Experience with Problem report, change request systems (e.g., Trackwise, Comet).
- ✓Document Management systems (e.g., TruVault).
- ✓Test tools (e.g., Kneat).
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