Data Integrity QMS consultant
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Data Integrity Consultant
Location: Remote - Europe
Contract: 3 months, with potential for extension
Start Date: ASAP
Working Language: English
Overview
We are looking for an experienced Data Integrity Consultant to support a Data Integrity Remediation Project within a GxP-regulated Life Sciences environment.
The assignment will focus on the Core Model and Quality Management System (QMS), supporting the assessment and remediation of data integrity risks across key business processes and associated data flows.
The successful consultant will work 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 on the data flow in the Core model
- Identification of Controls associated with the identified risks
- Drafting of an Audit Trail Review Strategy
- 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
- Working language: English
- Experience within a GxP-regulated healthcare environment is essential.