Jr. Data Integrity Specialist

Il y a 2 jours

Geel, Flanders, Belgique In4Matic Temps plein

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Our 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. Responsibilities
• Conduct gap assessments, map digital and hybrid data flows, and perform data integrity risk assessments using predefined protocols and standardized forms.
• Verify equipment interface reliability, checking that data generation and transfers are complete and accurate against the documented data flows.
• Assess audit trails, traceability, access management, user accounts, electronic data management, IT security, and equipment controls.
• Document compliance gaps and recommend appropriate remediation measures.
• Create, update, and review supporting documentation in collaboration with cross-functional specialists. Profile And Technical Skills
• Approximately 1-3 years of relevant experience in a highly regulated environment, preferably within the pharmaceutical industry.
• Familiarity with GxP requirements for analytical equipment in manufacturing and/or quality control settings.
• Strong knowledge of data integrity principles and the practical application of ALCOA++.
• Experience reviewing data flows, audit trails, control mechanisms, and access management for systems and applications.
• Knowledge and practical experience of risk management and risk-based approaches, such as ICH Q9.
• Strong analytical skills and a meticulous approach to assessment and documentation.
• Ability to work independently within clearly defined protocols and standardized documentation frameworks.
• Clear communication skills and the ability to collaborate effectively across functions. Practical Information
• Consulting assignment suited to a junior professional with relevant practical experience.
• Training and access to the relevant equipment and applications will be provided.
• Languages: fluent Dutch and fluent English. Contactperson & Reference
• Reference #: INW28621
• Isa Fars
• isa.fars@i4m.be

Jr. Data Integrity Specialist

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