Quality Assurance Employee

ph3Role /h3 pQuality Assurance Employee /p h3Reports to /h3 pQA Manager /p h3Main responsibilities /h3 ul liManages changes, complaints, deviations, and CAPAs through the electronic document management system. /li liCollects and organizes supporting documentation for change requests, complaints, supplier complaints, deviations, and CAPAs. /li liMonitors the progress of all GMP compliance activities defined in approved documents, reporting discrepancies to Supervisors. /li liDrafts and maintains GMP documentation such as Risk Assessments, cleaning and cross-contamination reports, qualification protocols and reports for equipment, plants, and environments. /li liDrafts and updates general and site-specific Standard Operating Procedures (SOPs). /li liVerifies staff participation and supervises the qualification status of personnel. /li liVerifies alarms on SCADA system in production and warehouse areas, ensuring they are handled appropriately. /li liCoordinates cleaning and cross-contamination activities in accordance with approved protocols and SOPs. /li liPrepares and updates GMP compliance lists, plans, and documentation under QA responsibility. /li liDrafts the Annual Product Quality Reviews (APQRs) and sends them to clients. /li liMonitors document expiration dates (SOPs, protocols, etc.) and ensures timely revisions. /li liEnsures compliance with documentation control procedures throughout the document lifecycle. /li liManage the Customer audit and assist management in regulatory inspection /li /ul h3Technical/Regulatory Skills Required /h3 ul liBasic knowledge of cGMP and data integrity regulations (ALCOA principles). /li liBasic knowledge of main manufacturing processes. /li /ul h3Soft Skills Required /h3 ul liAttention to detail and accuracy /li liTeamworking attitude /li liProblem-solving orientation /li liGood analytical skills /li /ul h3IT Skills Required /h3 ul liCompetency with Microsoft Office tools (Word, Excel, PowerPoint) /li liGood knowledge of document and management systems (preferred) /li liGood knowledge of SCADA systems (preferred) /li liBasic knowledge of SAP system /li /ul h3Language Skills Required /h3 ul liItalian: Native or professional proficiency, written and spoken (C1). /li liEnglish: Professional proficiency, written and spoken (B2) /li /ul h3Education /h3 ul liDiploma of Industrial Technical Institute with specialization in Chemistry, or Degree in Chemistry or Chemistry and Pharmaceutical Technology (preferred) /li /ul h3Previous experience in the role or similar position within the sector /h3 ul liMinimum 1-2 years experience in a similar role within the pharmaceutical sector. /li /ul h3Seniority level /h3 ul liEntry level /li /ul h3Employment type /h3 ul liFull-time /li /ul h3Job function /h3 ul liProduction /li /ul h3Industries /h3 ul liPharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr