CPV Digitalization Consultant

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Requirements:

• 10+ years in pharmaceuticals, with a focus on CPV or related quality assurance processes.
• Hands-on experience with CPV implementation, preferably in digital environments.
• Proficiency with statistical tools (e.g., JMP, Minitab, SAS).
• Expertise in AI/ML applications for process monitoring (preferred).
• Knowledge of regulatory requirements for CPV.
• Strong analytical and problem-solving skills.
• Excellent communication skills to collaborate across teams.
• Ability to create clear, actionable documentation.

Responsibilities:

• Map CPV workflows, identifying critical quality attributes, performance metrics, and pain points.
• Collaborate with manufacturing and quality teams to capture their data monitoring and compliance needs.
• Ensure alignment with FDA, EMA, and ICH CPV guidelines.
• Define audit-ready reporting features to maintain data integrity.
• Design statistical models for trend analysis, anomaly detection, and batch failure prediction.
• Recommend AI/ML solutions for predictive maintenance and real-time monitoring.
• Identify integration points with MES, LIMS, ERP, and other systems.
• Provide future-proof recommendations for scalable, cloud-based CPV solutions.
• Document workflows and reporting requirements, ensuring usability and scalability.