3 weeks ago

CSA & Quality Compliance Expert

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 1 hour agoStatus: Live

Job Summary

Consult as part of client projects to validate computerized systems in regulated environments across life sciences and medical devices. Draft and review validation documentation, support risk assessments, and ensure alignment with GxP and ISO standards. Participate in validation for systems such as ERP, MES, LIMS, and SCADA, provide evidence for audits, and deliver training and guidance to client personnel.

Location: Milan

Workplace: Hybrid

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Mid level

Key Responsibilities

•Draft and review validation documentation to meet relevant regulations and industry standards.
•Support validation projects for computerized systems (e.g., ERP, MES, LIMS, SCADA, and data integrity solutions).
•Perform risk assessments and impact analyses for computerized systems in pharma/biotech and medical device environments.
•Collaborate with cross-functional teams (IT, QA, and operations) to ensure compliance with GxP/ISO requirements.
•Support client and regulatory audits by providing evidence and required documentation, and deliver training and guidance to client personnel.

Key Requirements

•Degree in a scientific or technical discipline (e.g., Engineering, Computer Science, Biotechnology, Chemistry).
•3-5 years of experience in CSA activities within life science, supporting validation and compliance projects.
•Strong knowledge of regulatory requirements, including GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
•Experience with risk-based validation approaches and software validation in GxP contexts.
•Excellent analytical, planning, and problem-solving skills, with the ability to collaborate effectively with clients.

Experience:3-5 yearsLife sciencesMedical devicesRegulated environments

Skills:Analytical thinkingPlanningProblem-solvingCollaborationTraining

Languages:English

Tech Stack:Computer System ValidationCSAGxPGAMP 5FDA 21 CFR Part 11EU Annex 11ISO 13485EU MDRERPMESLIMSSCADAData Integrity

Company Brief

Dimension Data

Dimension Data, operating under NTT Ltd, provides managed IT services, cloud and data center solutions, networking, cybersecurity, and digital transformation services to enterprise customers worldwide.

Industry: Professional Services

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Valuation: Public Company (Market Cap in USD)

Headquarters: London, United Kingdom

Founded: 1983

Website LinkedIn

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Dimension Data

3 weeks ago

CSA & Quality Compliance Expert

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 1 hour agoStatus: Live

Job Summary

Location: Milan

Workplace: Hybrid

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Mid level

Key Responsibilities

•Draft and review validation documentation to meet relevant regulations and industry standards.
•Support validation projects for computerized systems (e.g., ERP, MES, LIMS, SCADA, and data integrity solutions).
•Perform risk assessments and impact analyses for computerized systems in pharma/biotech and medical device environments.
•Collaborate with cross-functional teams (IT, QA, and operations) to ensure compliance with GxP/ISO requirements.
•Support client and regulatory audits by providing evidence and required documentation, and deliver training and guidance to client personnel.

Key Requirements

•Degree in a scientific or technical discipline (e.g., Engineering, Computer Science, Biotechnology, Chemistry).
•3-5 years of experience in CSA activities within life science, supporting validation and compliance projects.
•Strong knowledge of regulatory requirements, including GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
•Experience with risk-based validation approaches and software validation in GxP contexts.
•Excellent analytical, planning, and problem-solving skills, with the ability to collaborate effectively with clients.

Experience:3-5 yearsLife sciencesMedical devicesRegulated environments

Skills:Analytical thinkingPlanningProblem-solvingCollaborationTraining

Languages:English

Tech Stack:Computer System ValidationCSAGxPGAMP 5FDA 21 CFR Part 11EU Annex 11ISO 13485EU MDRERPMESLIMSSCADAData Integrity

Company Brief

Dimension Data

Industry: Professional Services

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Valuation: Public Company (Market Cap in USD)

Headquarters: London, United Kingdom

Founded: 1983

Website LinkedIn