Jr. Data Integrity Specialist

Il y a 4 heures

Geel, Flanders, Belgique In4Matic Temps plein

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pOur client is seeking an early-career consultant to assess data integrity compliance for small GxP equipment, including analytical instruments and associated computerized applications used in manufacturing and quality control. This opportunity combines hands‑on compliance reviews with support from system subject matter experts and a project lead with extensive data integrity expertise. /p h3Responsibilities /h3 ul liConduct gap assessments, map digital and hybrid data flows, and perform data integrity risk assessments using predefined protocols and standardized forms. /li liVerify equipment interface reliability, checking that data generation and transfers are complete and accurate against the documented data flows. /li liAssess audit trails, traceability, access management, user accounts, electronic data management, IT security, and equipment controls. /li liDocument compliance gaps and recommend appropriate remediation measures. /li liCreate, update, and review supporting documentation in collaboration with cross-functional specialists. /li /ul h3Profile And Technical Skills /h3 ul liApproximately 1-3 years of relevant experience in a highly regulated environment, preferably within the pharmaceutical industry. /li liFamiliarity with GxP requirements for analytical equipment in manufacturing and/or quality control settings. /li liStrong knowledge of data integrity principles and the practical application of ALCOA++. /li liExperience reviewing data flows, audit trails, control mechanisms, and access management for systems and applications. /li liKnowledge and practical experience of risk management and risk-based approaches, such as ICH Q9. /li liStrong analytical skills and a meticulous approach to assessment and documentation. /li liAbility to work independently within clearly defined protocols and standardized documentation frameworks. /li liClear communication skills and the ability to collaborate effectively across functions. /li /ul h3Practical Information /h3 ul liConsulting assignment suited to a junior professional with relevant practical experience. /li liTraining and access to the relevant equipment and applications will be provided. /li liLanguages: fluent Dutch and fluent English. /li /ul h3Contactperson Reference /h3 ul liReference #: INW28621 /li liIsa Fars /li /ul

Jr. Data Integrity Specialist

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