Data Integrity QMS consultant

Red Commerce Schweiz GmbH; France; A distancia; EUR 83.000 - 124.000; A tiempo parcial

Descripción de la vacante

Red Commerce Schweiz GmbH is seeking an experienced Data Integrity Consultant for a 3-month remote assignment across Europe. The project focuses on data integrity remediation within a GxP-regulated life sciences context and will involve mapping data flows, risk assessment, and implementing appropriate controls.

The consultant will draft an audit trail review strategy and collaborate with stakeholders to ensure data flows and QMS processes (Deviation, Change Controls, Risk management, complaints,

Formación

• Experience in a GxP-regulated healthcare environment is essential.
• Strong knowledge of Data Integrity in data flows and core models.

Responsabilidades

• 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.

Descripción del empleo

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.