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Quality Assurance Specialist
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Quality Assurance Specialist
2 maanden geleden
About the Role:
The Quality Assurance Specialist supports the department and site in publishing of metrics and reports and meeting coordination of projects. This role interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects while being mentored by a senior QA Specialist/ QA Project Manager. The Quality Assurance Specialist is capable of identifying and resolving Quality issues with assistance. This role ensures superior customer service to internal customers.
Key Responsibilities:
- Partner with internal customers as part of minor change requests, CAPA and Deviations.
- Review and prepare the batch records for QP's batch disposition and review of related deviations, CAPAs and Change Requests within the defined due dates.
- Ensure that the batch records are closed and archived when all the activities batch related are completed.
- Review and approve Lonza documents such as SOPs, forms, master batch records, test methods, checklists, etc.
- Participate in QA On the floor tasks such as witnessing manufacturing/production support/warehouse/quality control activities.
- Manage and track Key Performance Indicator (KPI) and Quality metrics and support QA department for internal and external meetings (batch tracker meetings, deviation review board, IPT, etc).
- Flexibility to do shifts when needed to ensure QA OTF tasks are performed and that batch disposition of product with short expiry date can be done on time.
- Perform other duties as assigned.
Key Requirements:
- B.Sc. or M.Sc. level of thinking & working.
- Relevant working experience 2 to 3 years.
- Dutch working permit.