CSA & Quality Compliance Expert

NTT DATA Group

Milano

In loco

EUR 50.000 - 70.000

Tempo pieno

2 giorni fa

Candidati tra i primi

Generatore di candidature

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Supera i filtri ATS

Descrizione del lavoro

NTT DATA Group is seeking a CSA & Quality Compliance Expert with 3-5 years of experience in Computer System Validation to support validation and compliance projects for clients in pharma, biotech, and medical device sectors.

The role focuses on ensuring systems meet GxP/ISO standards, participating in risk assessments, and assisting audits while contributing to Life Science and Medical Device compliance initiatives.

Competenze

Draft and review validation documentation in compliance with industry regulations.
Participate in validation projects for computerized systems (ERP, MES, LIMS, SCADA, etc.).
Support compliance projects in Medical Device sector ensuring ISO 13485, EU MDR, and related regs.
Perform risk assessments and impact analyses for computerized systems.
Collaborate with IT, QA, and operations to ensure regulatory compliance.
Provide support during audits (FDA, EMA, ISO) with evidence and documentation.
Deliver training and guidance on validation and compliance in Life Science and Medical Devices.

Mansioni

Draft and review validation documentation for regulated environments.
Lead or participate in validation projects for computerized systems.
Support ISO 13485, EU MDR, and related regulatory compliance initiatives.
Perform risk assessments and impact analyses for systems.
Coordinate with IT/QA/Operations to ensure standards are met.
Assist during client and regulatory audits with required evidence.
Provide training on validation and compliance processes.

Descrizione del lavoro

CSA & 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 Description

The selected candidate will work as a consultant on client projects, managing and supporting the validation of computerized systems in regulated environments. 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 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.), supplying evidence and required documentation.
Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.

Available Languages