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Role description:
As a CSV Validation Specialist, you will play a pivotal role in developing and executing validation strategies for CSV projects, ensuring compliance with industry standards and company policies. Together with your team, you will create and maintain comprehensive validation documentation, including validation plans, protocols, and reports in accordance with SOP-1705 and other relevant SOPs in pharmaceutical industry.
* Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to ensure all validation efforts meet project timelines and specifications.
* Ensure adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.
Provide guidance and training to team members on CSV best practices and procedural compliance.
Your profile
Must Have :
* Bachelor’s or master’s degree in a related field (e.g., Computer Science, Information Technology, Engineering).
* Minimum of 3-5 years of experience in CSV validation, preferably in a regulated environment.
* Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.
* Strong analytical and problem-solving skills to identify issues and implement corrective actions.
* Strong background in IT validation, specifically within the pharmaceutical or healthcare industry.
Nice to Have
* Familiarity with industry standards and regulations relevant to CSV (e.g., GxP, 21 CFR Part 11).
* Experience with validation tools and methodologies.
* Ability to create detailed, compliant documentation (SOPs, validation protocols, reports).
WHAT YOU’LL LOVE ABOUT WORKING HERE?
* At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
* Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
* OUTfront, Women@Capgemini or CapAbilityare 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.
ABOUT CAPGEMINI
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
Get the future you want | www.capgemini.com
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