Data Integrity & QMS Consultant - Remote (GxP)

Red Commerce Schweiz GmbH; France; Remote; EUR 83,000 - 124,000; Part time

Job summary

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,

Qualifications

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

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.

Job description

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,