Data Integrity QMS consultant

Support Data Integrity Remediation in a GxP-Regulated Life Sciences Environment

Join a dedicated team to support a Data Integrity Remediation Project within a GxP-regulated Life Sciences environment. This three-month assignment, with potential for extension, requires immediate availability and focuses on the Core Model and Quality Management System (QMS). The role involves supporting the assessment and remediation of data integrity risks across key business processes and associated data flows.

Working closely with relevant stakeholders, you will map data flows, assess data integrity risks, define appropriate controls, and establish an effective audit trail review strategy. This opportunity is ideal for professionals with essential experience in GxP-regulated healthcare environments, including API, drug product, vaccines, medical devices, and combination products.

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

Required Expertise

• 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