CSV & Data Integrity (DI) GAP Assessment Consultant

CSV & Data Integrity (DI) GAP Assessment Consultant

• Location: Remote – occasionally on site (London area– UK)

• Duration: 6 months (April – December 2024)

About the Role:

We are seeking an experienced CSV consultant to lead a comprehensive Computer System Validation (CSV) and Data Integrity (DI) gap assessment across its global network of manufacturing sites. The primary objective is to assess compliance with 21 CFR Part 11 regulations for biotech manufacturing sites.

Key Responsibilities:

• Develop a matrix to verify compliance with CSV and DI requirements within production and quality control departments at each site.
• Develop a standardized methodology and assessment framework to identify and document any deviations from best practices and regulatory requirements.
• Participate/oversee in the pilot gap assessment of CSV and DI practices for their UK pilot plant.
• Create a knowledge base and training materials to enable internal teams to conduct future gap assessments independently.
• Provide guidance and support to internal teams on implementing corrective and preventive actions (CAPAs) to address identified gaps.
• Present findings and recommendations to management.

Qualifications:

• Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Life Sciences).
• Minimum 5 years of experience in CSV and DI within the pharmaceutical or biotechnology industry.
• Strong understanding of GMP principles and their application to CSV and DI.
• In-depth knowledge of 21 CFR Part 11 regulations and related guidance documents.
• Proven experience conducting gap assessments and developing remediation plans.