CSV Consultant

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a GMP Auditor to join our amazing team. 

Job Title: CSV Consultant 

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview:

We are seeking a highly skilled and experienced freelance CSV (Computer System Validation) Consultant to join our team. The ideal candidate will have a strong background in regulatory compliance, quality assurance, and information technology, with expertise in CSV principles and practices. As a freelance consultant, you will be responsible for providing guidance, support, and expertise to clients in validating computerised systems used in regulated industries, such as pharmaceuticals, biotechnology, medical devices, and healthcare.

Responsibilities:

• Collaborate with clients to develop and execute CSV strategies, plans, and protocols for computerised systems by regulatory requirements (e.g., FDA, EMA, MHRA) and industry best practices.
• Conduct risk assessments and gap analyses to identify validation requirements, critical systems, and potential areas of non-compliance.
• Guide the selection, implementation, and configuration of software applications, IT infrastructure, and cloud-based solutions to ensure compliance with CSV requirements.
• Review system requirements, user requirements, functional specifications, and design documents to ensure completeness, accuracy, and traceability throughout the validation lifecycle.
• Develop and execute validation protocols, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and validation test scripts, to verify system functionality and performance.
• Perform validation activities, such as protocol execution, test execution, and documentation of test results, deviations, and discrepancies, in compliance with established procedures and timelines.
• Prepare validation documentation, including validation plans, risk assessments, traceability matrices, validation summary reports, and compliance documentation, to support regulatory submissions and audits.
• Provide training and guidance to client personnel on CSV principles, validation methodologies, and best practices for maintaining compliant computerized systems.

Requirements:

• Bachelor’s degree in computer science, engineering, life sciences, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in CSV and computerized system validation, with a minimum of 5 years working in regulated industries, such as pharmaceuticals, biotechnology, medical devices, or healthcare.
• In-depth knowledge of regulatory requirements for CSV, including FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and other relevant guidelines and standards.