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Quality assurance specialist (albignasego)

Albignasego
Michael Page
Pubblicato il 8 aprile
Descrizione

Randstad Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for a Product Quality Vigilance.The Non-Combination Product Analyst III will be responsible for handling adverse events and E2E product quality complaint activities.Work area: LatinaRange RAL: 34000€ - 40000€DUTIES & RESPONSIBILITIES:Perform end-to-end complaint handling activities, including but not limited to Intake, triaging, recovery of field samples for evaluation, due diligence will be performed with complainant/intake centres/LOCs), trend analysis, defect coding, risk criticality assessment, holistic review and closure of investigations.Ensure that uniform and timely management of complaint records from receipt to closure, and investigations are accurately assessed for risk prioritization and performed per procedures, standards and regulations.Compile and analyse data, metrics and trends associated with complaint handling processes.Support internal and external audits and inspections; demonstrate ability to communicate regulatory and processpositions as an SME during regulatory inspections.PROFESSIONAL EXPERIENCE REQUIREMENTS:2-3 years of related experience including Quality Assurance and/or Quality Control, including experience workingin pharmaceutical and/or Medical Device or other related highly regulated industryBachelor's degree or master's degree (preferred) in technical, scientific, or engineering disciplines required.Global mindset and demonstrated ability for change initiatives, project management and develop strong relationships

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