10 ago - Italia
Experteer Italy
Experteer Overview In this role you will ensure product quality and regulatory compliance to support production of life-changing medicines. You will join a quality-focused team that helps enable Thermo Fisher's mission to make the world healthier, cleaner and safer. You'll oversee quality activities across pharmaceutical manufacturing, solving complex problems and supporting inspections. This role offers collaboration with cross-functional teams and opportunities to drive improvements in aseptic processes and quality systems. Retribuzione / Benefits Oversee quality oversight of pharmaceutical manufacturing operations Review batch records and lead deviation investigations Manage CAPA processes and track corrective actions Support regulatory inspections and customer audits Ensure compliance with GMP and FDA guidelines across quality documentation systems Coordinate with cross-functional teams to drive quality improvements Maintain knowledge of aseptic manufacturing controls and gowning procedures Utilize quality systems (e.g., Track Wise, Documentum)
and MS Office for documentation and reporting Responsabilità 4 years of experience in pharmaceutical quality assurance or related GMP environment 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 (Track Wise, Documentum) Professional communication skills (written and spoken) Ability to manage multiple priorities in a dynamic environment Strong attention to detail and analytical problem-solving Effective interpersonal and communication abilities Project management and organizational capabilities Experience supporting regulatory inspections and customer audits Experience working with cross-functional teams Proficiency with Microsoft Office applications Knowledge of root cause analysis and quality
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