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Csv & di squad lead

Geel
Panda International
Publiée le 1 juillet
Description de l'offre

Vacancy: Squad Lead – Computer System Validation (CSV) & Data Integrity (DI)Location: Geel region, Belgium On-site presence: Minimum 80% required Employment type: Contract / Project-basedAbout the RoleWe are currently seeking an experienced Squad Lead for Computer System Validation (CSV) and Data Integrity (DI) for a leading pharmaceutical manufacturing site in the Geel region. In this role, you will co-lead, alongside local process owners, the alignment of existing CSV and DI practices with current industry standards. A strong focus will be placed on risk-based methodologies, regulatory compliance, and sustainable implementation of best practices within a GMP-regulated environment.Key ResponsibilitiesProvide direction on CSV & DI best practices, applying science-based, risk management approachesOversee multiple ongoing projects and manage both internal and external resources (contractors)Ensure the quality and regulatory compliance of project deliverables, in close collaboration with QADrive change management initiatives to ensure long-term adoption of improved processesMentor and coach the Local Process Owner (LPO) to elevate knowledge and adherence to industry standardsYour ProfileStrong expertise and hands-on experience with CSV and data integrity in a pharmaceutical manufacturing environmentPreferably experienced in an API setting, with knowledge of DeltaV, PI, PCS7, and alarm management best practicesIn-depth knowledge of FDA and EMA expectations on CSV and DI, with practical experience using risk-based validation approaches and documentationExcellent project management skills, including planning, organizing, and coordinatingDemonstrated ability to lead teams in complex and fast-paced environmentsSkilled in coaching, change management, and trainingAble to navigate across multiple organizational levels and influence without direct authorityLanguage requirements: English (required), Dutch (preferred)What’s OfferedA strategic and high-impact role within a global pharmaceutical environmentDynamic and multidisciplinary project workCompetitive compensation (freelance or fixed-term contract possible, depending on your profile)Opportunity to make a lasting contribution to compliance, quality, and innovationInterested or want to learn more? Please get in touch or send your CV to s.canelas@panda-int.com .

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