Csa & Quality Compliance Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/791lhe

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.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/791lhe