James Moane

Csv Engineer @LifeScan

Leading routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements such as ISO, IEC, FDA, CFR, Annex 11 and guidance such as GAMP\\\\n• Providing assurance and guidance of the development of CSV documentation (Validation Plans, Requirements / Specifications / Assessments, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs, etc for GxP system lifecycles from new complex systems to low level like for like systems.\\\\n• Developing and specifying standards, methods or procedures to determine product quality or release readiness.\\\\n• Supporting with CSV re-evaluations, user management, backups and audit trail assessments and reviews.\\\\n• Owning and providing support with CAPAs & NCs, change controls and deviation investigations.\\\\n• Reviewing and approving protocols, reports, SOPs, work instructions.\\\\n• Successfully passing a Quality Management course gaining a mark of ‘Outstanding Distinction’.\\\\n• Creating new processes within the CSV team – Investigating for gaps and implementing new methods.\\\\n• Leading the implementation of the test management software tool qTest. This involved the move away from paper-based testing to paperless testing and championing the training of multiple teams within quality.\\\\n• Providing oversight to ensure consistent use of Policies, Procedures, Standards and Guidelines relating to computer system development, operation, and maintenance.\\\\n• Providing quality support to manufacturing – health and safety, self-inspections, audits, IT, batch release, GMP standards.\\\\n• Reviewal and approving of system life cycle deliverables, documents, specifications (user, functional, and detailed design) Periodic Validation Reviews, SOPs and work instructions. Providing expertise to operations in the evaluation of process, equipment, and software applicability.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n