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CSV Expert - Pharma - 6 months contract - Remote

Our Client is looking for CSV Expert with Pharma Experience. In this role you will providing operational support for initial validation of computer systems, particularly ERP systems, and independently creating comprehensive documentation throughout the system life cycle, including validation plans, test plans, and risk analyses. Additionally, the candidate will monitor and implement project activities, collaborate with internal and external stakeholders, and provide expert advice to optimize existing validation concepts while ensuring compliance with industry regulations and standards.

Tasks:

• Provide Operational Support for Initial Validation of CS Systems: Assist with the initial validation of computer system (CS) environments, including Enterprise Resource Planning (ERP) systems, ensuring they meet compliance and operational standards.
• Create Documentation Independently in the Life Cycle Process: Develop comprehensive documentation throughout the system life cycle, including validation plans, test plans, and risk analyses. Ensure all documentation adheres to regulatory and company standards.
• Monitor and Implement Project Activities: Oversee and execute project activities in collaboration with both internal and external stakeholders. Ensure all activities are aligned with project goals and timelines.
• Advise and Optimize Existing Validation Concepts: Provide expert advice and support for the enhancement and optimization of current validation concepts. Focus on improving efficiency, compliance, and effectiveness.

Qualification:

• Extensive Professional Experience in CSV and Pharmaceutical Environment: Demonstrated several years of experience working with Computer System Validation (CSV) within a regulated pharmaceutical context, including adherence to Good Practice (GxP) standards.
• Expert Knowledge in CSV: Possess excellent knowledge and understanding of CSV principles and practices. Certification as a CSV expert is highly advantageous.
• In-depth Understanding of Data Integrity and Regulatory Standards: Thorough knowledge of data integrity principles, Electronic Records and Electronic Signatures (ERES) requirements, and relevant international regulations, such as Annex 11, 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP 5).
• Experience with Relevant Software Packages: Familiarity and hands-on experience with the software packages mentioned (ERP systems and others) is ideal and beneficial for this role.

Reference
CR/091489_1718986163