Jr. Data Integrity Specialist

In4Matic

Geel

On-site

EUR 42,000 - 65,000

Full time

46 hours ago
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Job summary

In4Matic seeks a junior consultant to assess data integrity compliance for GxP equipment and associated computerized applications used in manufacturing and quality control. You will perform hands-on reviews under the guidance of senior SMEs and a project lead with extensive data integrity expertise.

Training and access to relevant equipment and applications are provided; fluent Dutch and fluent English are required to collaborate across functions within a regulated environment in Belgium.

Qualifications

  • ~1–3 years in a highly regulated environment, preferably pharma.
  • Familiarity with GxP requirements for analytical equipment in manufacturing/QA.
  • Strong knowledge of data integrity principles and ALCOA++.
  • Experience reviewing data flows, audit trails, control mechanisms, and access management.

Responsibilities

  • Conduct gap assessments, map digital/hybrid data flows, and perform data integrity risk assessments.
  • Verify equipment interface reliability and data transfer completeness against documented data flows.
  • Assess audit trails, traceability, access management, user accounts, and IT security.
  • Document compliance gaps and recommend remediation measures.
  • Create, update, and review supporting documentation with cross-functional specialists.

Skills

GxP knowledge
Data integrity
ALCOA++
Audit trails
Risk management
Analytical skills
Documentation
Communication skills

Job description

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
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