Validation Consultant

Il y a 2 heures
East Flanders, Flanders, Belgique Pauwels Consulting Temps plein
pOur client, a leading biotechnology organization, is seeking a Validation Consultant to support their electronic compliance team and computer systems lifecycle management. This role focuses on ensuring that IT quality processes and validation activities are aligned with international regulatory standards and risk-based principles. /p h3Responsibilities /h3 ul liLead the authoring, review, and approval of validation and qualification deliverables within an electronic document management system. /li liDrive the consistent application of GAMP 5 and risk-based validation principles across the project. /li liProvide validation oversight to ensure deliverables are complete, consistent, and compliant with industry standards. /li liIdentify, assess, and manage validation risks and quality events including change controls, deviations, and CAPAs. /li liContribute to the continuous improvement of validation and qualification SOPs, standards, and templates. /li liProvide CSA and CSV subject‑matter expertise to project teams to resolve complex compliance issues. /li liOversee the successful completion of release management for various digital platforms and solutions. /li /ul h3Requirements /h3 ul liBachelor’s or Master’s degree in Computer Science, Life Sciences, or Engineering. /li liYou have 5+ years of hands‑on experience in CSV and CSA within a regulated industry such as pharma or biotech. /li liYou bring extensive knowledge of GxP computerized‑system lifecycle management, including validation planning, risk assessment, and data integrity. /li liYou possess technical experience with cloud data warehouses like Snowflake or Databricks and visualization tools such as Tableau or Power BI. /li liYou have deep familiarity with AI governance frameworks and the validation of complex systems like Generative AI and LLMs. /li liYou're able to communicate and influence across multidisciplinary teams while providing pragmatic solutions in regulated environments. /li liYou are fluent in English. /li /ul h3Nice to Haves /h3 ul liExperience with enterprise platforms such as Veeva, ERP, Jira, ServiceNow, and IAM technologies. /li liExperience with data platforms, analytics qualification, and related framework assessments. /li liPrior experience with the validation of computerized systems leveraging AI functionalities in a regulated environment. /li /ul

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