Quality on the floor specialist

10 ago - Italia
Experteer Italy

Experteer Overview Lead QA Technician within the Quality team, ensuring product quality and regulatory compliance to support life-changing medicines. You will collaborate across functions to uphold GMP standards and enable safe, effective manufacturing. Your work directly supports the mission to make the world healthier, cleaner, and safer by ensuring robust quality systems and processes. This role offers exposure to regulatory inspections, CAPA management, and continuous improvement in a fast-paced environment. Retribuzione / Benefits Oversee quality assurance activities during pharmaceutical manufacturing operations Review batch records and investigate deviations; manage CAPA programs Support aseptic manufacturing processes and controls Contribute to regulatory inspections and customer audits Maintain and improve quality documentation systems (e.g., Track Wise, Documentum)



Collaborate with cross-functional teams to ensure compliance and continuous improvement Interpret and apply technical procedures and specifications Provide guidance and development for team members and shift operations Responsabilità 4 years of experience in pharmaceutical QA or GMP environments Comprehensive knowledge of GMP regulations and FDA guidelines Experience with deviation investigations, CAPA management, and batch record review Strong understanding of aseptic manufacturing processes and controls Advanced proficiency with quality documentation systems (Track Wise, Documentum) Effective written and verbal communication; strong attention to detail Ability to manage multiple priorities in a dynamic setting Experience supporting regulatory inspections and audits Proficiency with Microsoft Office Knowledge of root cause analysis and quality improvement tools Experience with clean room operations and gowning procedures preferred Ability to interpret technical procedures and specifications Cross-functional teamwork skills #J-18808-Ljbffr

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