Engineering Quality Assurance Engineer
10 minuti fa
SOLAMENTE LE CANDIDATE / I DOMICILIATI ENTRO 30 KM DAL SITO DI TRIBIANO VERRANNO CONSIDERATI PER QUESTA SELEZIONE.RoleQuality Assurance EmployeeReports toQA ManagerMonitors the progress of all GMP compliance activities defined in approved documents, reporting discrepancies to Supervisors.Drafts and maintains GMP documentation such as Risk Assessments, cleaning and cross-contamination reports, qualification protocols and reports for equipment, plants, and environments.Prepares and updates GMP compliance lists, plans, and documentation under QA responsibility.Drafts the Annual Product Quality Reviews (APQRs) and sends them to clients.Monitors document expiration dates (SOPs, protocols, etc.) Ensures compliance with documentation control procedures throughout the document lifecycle.Manage the Customer audit and assist management in regulatory inspectionTechnical / Regulatory Skills RequiredBasic knowledge of cGMP and data integrity regulations (ALCOA principles).Competency with Microsoft Office tools (Word, Excel, PowerPoint)Basic knowledge of SAP systemLanguage Skills RequiredItalian : Native or professional proficiency, written and spoken (C1).English : Professional proficiency, written and spoken (B2)Diploma of Industrial Technical Institute with specialization in Chemistry, or Degree in Chemistry or Chemistry and Pharmaceutical Technology (preferred)Engineering Quality Assurance Engineer mwd • Rome, Italy#J-*****-Ljbffr
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