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BRR and Disposition Quality Specialist
On-site · Ferentino, Lazio, Italy
Job Summary
BRR and Disposition Quality Specialist responsible for quality oversight of pharmaceutical manufacturing operations, following internal SOPs and meeting regulatory requirements; collaborating with Production, Technology Transfer and Quality teams to manage master data and batch records, handle deviation investigations and CAPA, and support regulatory inspections. Requires GMP experience, knowledge of TrackWise/Documentum, aseptic manufacturing understanding, strong communication and cross-functional collaboration skills, and the ability to work across multiple priorities. Role involves tailored responsibilities based on experience and capabilities and supports Thermo Fisher Scientific’s mission in serving science.
Required Qualifications
- 2 years of experience in pharmaceutical quality assurance or related GMP environment
- Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field
- Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
- Expertise in batch record review, deviation investigations and CAPA management
- Strong understanding of aseptic manufacturing processes and controls
- Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)
- Professional communication skills both written and spoken
- Ability to manage multiple priorities in a dynamic environment
- Strong attention to detail and analytical problem-solving skills
- Project management and organizational capabilities
- Experience supporting regulatory inspections and customer audits
- Demonstrated ability to work effectively with cross-functional teams
- Proficiency with Microsoft Office applications
- Ability to work various shifts as required
- Knowledge of root cause analysis and quality improvement tools
- Demonstrated ability to guide and develop team members
- Experience with clean room operations and gowning procedures preferred
- Ability to understand and interpret technical procedures and specifications
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