Csa & Quality Compliance Expert

1 settimana fa

Milano, Italia NTT Data A tempo pieno

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.

  • Amp Retrofit Project Technical Manager

    7 giorni fa

    Milano, Italia Cavotec A tempo pieno

    Cavotec is a leading engineering company with 50 years of heritage in innovation, designing and delivering advanced connection and electrification solutions that drive the decarbonisation of ports and industrial applications.With five decades of experience, our systems ensure safe, efficient, and sustainable operations for a diverse range of customers and...

  • Csa Construction Manager

    2 settimane fa

    Milano, Italia Quanta Part Of Qcs Staffing A tempo pieno

    Are you a CSA Construction Manager looking for your next contract role?We have a fantastic opportunity for you to join our valued client in Milan on an initial 12-Month contract.Experienced at delivering highly efficient projects for state-of-the-art Data Centres, Pharma, Semi- Conductor infrastructures around the world, our client is a global leader in...

  • CSA Construction manager

    2 settimane fa

    milano, Italia Quanta part of QCS Staffing A tempo pieno

    Are you a CSA Construction Manager looking for your next contract role? We have a fantastic opportunity for you to join our valued client in Milan on an initial 12-Month contract.Experienced at delivering highly efficient projects for state-of-the-art Data Centres, Pharma, Semi- Conductor infrastructures around the world, our client is a global leader in...

  • CSA Construction manager

    2 settimane fa

    Via Milano, Italia Quanta part of QCS Staffing A tempo pieno

    Are you a CSA Construction Manager looking for your next contract role? We have a fantastic opportunity for you to join our valued client in Milan on an initial 12-Month contract.Experienced at delivering highly efficient projects for state-of-the-art Data Centres, Pharma, Semi- Conductor infrastructures around the world, our client is a global leader in...

  • Compliance Quality Assurance Specialist

    3 giorni fa

    Milano, Italia ING A tempo pieno

    Compliance Quality Assurance (CQA) team has the purpose to run local quality assurance activities that include Second Line Monitoring (SLM), Independent Testing activities (incl. Key Control Testing), QA Thematic Reviews, QA Continuous Monitoring and Process Reviews, as well as contributing to Business Line or Group QA-driven initiatives. The team monitors...

  • Compliance Quality Assurance Specialist

    7 giorni fa

    milano, Italia ING Italia A tempo pieno

    Join to apply for the Compliance Quality Assurance Specialist role at ING ItaliaCompliance Quality Assurance (CQA) team has the purpose to run local quality assurance activities that include Second Line Monitoring (SLM) Independent Testing activities (incl. Key Control Testing), QA Thematic Reviews, QA Continuous Monitoring and Process Reviews, as well as...

  • Compliance Quality Assurance Specialist

    7 giorni fa

    milano, Italia ING A tempo pieno

    Compliance Quality Assurance (CQA) team has the purpose to run local quality assurance activities that include Second Line Monitoring (SLM) Independent Testing activities (incl. Key Control Testing), QA Thematic Reviews, QA Continuous Monitoring and Process Reviews, as well as contributing to Business Line or Group QA-driven initiatives.The team monitors and...

  • Compliance Quality Assurance Specialist

    7 giorni fa

    Milano, Italia ING Italia A tempo pieno

    Join to apply for the Compliance Quality Assurance Specialist role at ING Italia Compliance Quality Assurance (CQA) team has the purpose to run local quality assurance activities that include Second Line Monitoring (SLM) Independent Testing activities (incl. Key Control Testing), QA Thematic Reviews, QA Continuous Monitoring and Process Reviews, as well as...

  • Field Service Representative

    2 settimane fa

    Milano, Lombardia, Italia CSA Group A tempo pieno

    Employment Status:RegularTime Type:Full timeBUILDING A WORLD CLASS TEAM STARTS WITH YOUAt the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes &...

  • Field Service Representative

    1 settimana fa

    Milano, Lombardia, Italia CSA Group A tempo pieno

    Employment StatusRegularTime TypeFull timeBUILDING A WORLD CLASS TEAM STARTS WITH YOUAt the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes &...