Data Integrity QMS Consultant / Data Integrity QMS Consultantess

Data Integrity Consultant

Location: Remote - Europe

Contract: 3 months, with potential for extension

Start Date: ASAP

Working Language: English

Overview

We are seeking an experienced Data Integrity Consultant to support a Data Integrity Remediation Project within a GxP-regulated Life Sciences environment. This role focuses on the Core Model and Quality Management System (QMS), aiming to assess and remediate data integrity risks across key business processes and associated data flows.

The successful consultant will collaborate closely with relevant stakeholders to map data flows, assess data integrity risks, define appropriate controls, and establish an effective audit trail review strategy.

Key Responsibilities

• Drafting of Data Flows
• Identification of risks related to data integrity within the Core Model data flow
• Identification of controls associated with identified risks
• Drafting of an Audit Trail Review Strategy
• Ensuring data integrity in a GxP-regulated healthcare environment (API, drug product, vaccines, medical devices, combination products)
• Knowledge of QMS processes: Deviation, Change Controls, Risk management, complaint management, documentation management
• Data Flow mapping

Experience within a GxP-regulated healthcare environment is essential.

If you believe your skills align with the job description, please apply online using the form below. Please note that only applications matching the job profile will be considered.