QUALITY ASSURANCE COMPLIANCE EXPERT

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7m2eh0

Industria PharmaWork Modality: Híbrido/FlexibleProcess: a07KA0000015GFuYAMCompany: NTT DATAOffer DescriptionCSA & Quality Compliance Expert with 3-5 years of experience in Computer System Validation to support compliance and validation projects for our clients, including top pharmaceutical, biotech, and medical device companies.Role DescriptionThe selected candidate will work as a consultant on client projects, managing and supporting the validation of computerized systems in regulated environments. Si candidi rapidamente per massimizzare le sue possibilità di essere considerato/a per un colloquio. They will contribute to strategic initiatives in Life Science and Medical Device compliance, ensuring systems align with regulatory requirements, GxP/ISO standards, and industry best practices. Knowledge of medical device compliance is considered a plus.Key ResponsibilitiesDraft 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.RequirementsRequirementsDegree 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 ma

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7m2eh0