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CSA & Quality Compliance Expert

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NTT DATA

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Location:
Italy , Milan

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The CSA & Quality Compliance Expert will support compliance and validation projects for leading pharmaceutical and medical device companies. With 3-5 years of experience in Computer System Validation, the candidate will draft validation documentation, participate in validation projects, and collaborate with cross-functional teams to ensure compliance with regulatory standards. A degree in a scientific or technical discipline is required, along with strong analytical and problem-solving skills. Proficiency in English is essential.

Job Responsibility:

  • 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

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
  • Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11
  • Experience with risk-based validation approaches and familiarity with software validation in GxP contexts
  • Ability to manage complex projects and effectively collaborate with clients across multiple industries
  • Excellent analytical, planning, and problem-solving skills
  • Proficiency in English, both written and spoken

Nice to have:

Knowledge of medical device compliance is considered a plus

Additional Information:

Job Posted:
January 24, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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