Data Integrity QMS Consultant

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.

If you think that your skillset match the JD, please apply with your CV.