Csa & Quality Compliance Expert Milano

Csa & Quality Compliance Expert
Milano
Lombardia, Milano

CSA & Quality Compliance Expert with at least 3 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:

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

**Requirements**:

- Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.

).

- At least 3 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.