09 set - Monza
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Reporting to the assigned QA Operations Team Leader, the PDS QA Project Specialist supports the Qualified Person (QP) in the evaluation and certification of manufactured batches and the manufacturing environment by reviewing Certificates of Analysis and all supporting quality documentation. The role performs preliminary impact assessments of deviation events, reviews investigation reports, manages customer complaints, and reviews investigation records in compliance with company standards, internal procedures, and applicable regulations (GMP, FDA, and other relevant requirements).
RESPONSIBILITIES
Batch Release Support
- Support the Qualified Person (QP) and the Quality Operations Manager in batch release activities by ensuring compliance with product specifications
- Ensure proper filing and archiving of all Batch Record documentation in accordance with company procedures and quality standards.
Investigation Record Review
- Perform preliminary assessments of deviations and customer complaints, assign the initial criticality level, and evaluate the need for escalation to management.
- Review investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs).
- Perform comprehensive reviews of deviation and complaint investigations, including:supporting investigation documentation; quality impact assessment on affected batches and manufacturing areas; regulatory and compliance impact assessments.
- Contribute to achieving departmental Zero Past Due objectives as well as Right First Time (RFT) and On-Time Delivery (OTD) targets.
- Approve CAPAs and evaluate effectiveness verification.
Customer Management & Inspections
- Participate in periodic customer meetings and provide quality support by responding to customer inquiries related to the assigned area of responsibility.
- Notify customers of deviations and c
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