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Csv validation specialist

Beerse
Panda International
Publiée le Publiée il y a 8 h
Description de l'offre

Job Title: CSV Validation Specialist Industry: Pharmaceuticals / Life Sciences / Information TechnologyJob Type: ContractLocation: Beerse, Belgium - Turnhoutseweg SiteStart Date: 11/08/2025End Date: 10/02/2026Duration: 6 MonthsWork Authorization: Must be authorized to work in BelgiumLanguage Requirements: Fluent English and Dutch (spoken and written)Job Description:Our client, a global pharmaceutical leader, is seeking a CSV Validation Specialist with strong experience in IT and software validation within a regulated environment. The ideal candidate will have a solid grasp of the Software Development Life Cycle (SDLC), ideally with prior experience working at healthcare/pharmaceutical companie. This position is based at the Beerse campus (Turnhoutseweg) and requires an expert in Computer System Validation (CSV) aligned with industry best practices and internal compliance procedures, such as SOP-1705.Key Responsibilities:Develop and execute validation strategies for computer system validation (CSV) projects in line with company and regulatory standardsCreate and maintain comprehensive documentation (validation plans, protocols, reports) per SOP-1705 and related proceduresPerform risk assessments and define mitigation strategies for validation activitiesLead or participate in testing phases including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)Collaborate with IT, QA, and regulatory teams to ensure project compliance and timely deliveryEnsure adherence to internal compliance policies and external regulatory requirements (e.g., FDA, ISO)Train and guide team members on CSV best practices and procedural adherenceRequired Skills & Experience:3-5 years of hands-on experience in computer system validation within a regulated pharmaceutical or healthcare environmentStrong understanding of the SDLC and its application in CSVPrior experience with healthcare/pharmaceutical companies strongly preferredProven track record in creating and managing validation documentationStrong analytical and problem-solving skillsExcellent communication and collaboration abilitiesPreferred Qualifications:Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related fieldKnowledge of GxP, 21 CFR Part 11, and industry-specific validation regulationsFamiliarity with validation tools and methodologiesInterested? Send your CV to m.gomes@panda-int.com to discuss further!

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