Quality Specialist, Quality Compliance
Pubblicato il 07-09-2026 - Altro in Italia
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CSA & Quality Compliance Expert 3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies.
Contributo a iniziative strategiche per Life Science e Medical Device compliance, assicurando l'allineamento con requisiti regolatori, standard GxP/ISO e best practice del settore. La conoscenza della compliance dei dispositivi medici è considerata un vantaggio.
Key Responsibilities Draft and review validation documentation in compliance with industry regulations.
Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA and Data Integrity solutions.
Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR and other relevant regulations.
Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.
Collaborate with cross-functional teams, including IT, QA and operations, to ensure compliance with standards and regulations.
Provide support during client and regulatory audits (FDA, EMA, ISO etc.), Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.
Requirements Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry etc.).
At least 3-5 years of experience in CSA activities within Life Science.
Experience with risk-based validation approaches and familiarity with software validation in GxP contexts.
Ability to manage complex projects and effectively