CSV & GMP Data Integrity Specialist

cGMP Data Integrity and CSV Remediation Specialist

Contract | Onsite | Lyon

We are currently recruiting an experienced cGMP Data Integrity and CSV Remediation Specialist to support a critical regulatory compliance project at a regulated manufacturing site in Lyon.

This is a senior contract consulting engagement requiring onsite deployment. The successful consultant will assess existing data integrity controls, identify and prioritise compliance risks, develop a structured remediation strategy and support the implementation of corrective actions.

Responsibilities

• Perform comprehensive cGMP data integrity gap assessments across manufacturing, laboratory, quality and computerised system environments
• Identify and prioritise data integrity and GMP compliance risks using a structured, risk-based methodology
• Develop remediation strategies, quality remediation plans and implementation roadmaps
• Support the development and execution of corrective and preventive actions
• Assess electronic and paper-based records against applicable data integrity expectations
• Review computerised systems and validation controls against GAMP 5 and EU Annex 11 requirements
• Support improvements to validation processes, quality systems, procedures and governance
• Conduct mock inspections and inspection readiness assessments
• Review documentation for completeness, traceability, accuracy and regulatory compliance
• Communicate findings and recommendations to quality, manufacturing, laboratory, IT and site leadership teams
• Support the site during regulatory remediation and inspection preparation activities

Experience and Qualifications

• Strong experience within pharmaceutical or biotechnology manufacturing
• Demonstrable data integrity assessment and remediation experience
• Strong working knowledge of Computer System Validation
• Experience applying GAMP 5 and EU Annex 11 requirements
• Experience supporting regulatory inspections, inspection observations or formal remediation program
• Working knowledge of FDA 21 CFR Parts 210 and 211
• Knowledge of EU GMP, ICH Q9 and ICH Q10
• Experience developing CAPAs, remediation plans and risk assessments
• French and English fluency, including technical writing
• Availability for onsite contract deployment in France

Candidates should be capable of operating independently within a high-priority remediation environment and communicating complex compliance risks clearly to both technical and senior management stakeholders.

For further information, please contact Seán McCarthy on +353 (0) or