CSV Expert with knowledge of Kneat

CSV Expert with knowledge of Kneat

We are currently supporting a client in their search for an experienced Computer System Validation (CSV) Expert with hands-on expertise in Kneat. This is a freelance role which can be on a fully remote basis, with a planned start in Q4 2024, focusing on validation management and technical documentation within a regulated environment.

Key Responsibilities:
* Lead and manage computer system validation (CSV) activities across various systems and projects
* Execute validation strategies in alignment with GxP and regulatory requirements
* Work extensively within Kneat for documentation, workflows, and reporting
* Oversee validation plans, risk assessments, protocols, and reports
* Prepare and maintain clear, concise, and audit-ready technical documentation
* Collaborate with QA, IT, and business stakeholders throughout the validation lifecycle

Required Skills & Experience:
* Proven experience in CSV (Computer System Validation) in a GxP-regulated environment
* Strong background in validation management across multiple systems or departments
* In-depth, hands-on experience using Kneat software
* Excellent technical writing skills in English
* Strong knowledge of relevant regulations (e.g. FDA, EU Annex 11, GAMP 5)
* Self-motivated, detail-oriented, and able to work independently in a remote setup

Further information:
Location: Remote
Start Date: Q4 2024
Language: English
Contract Type: Freelance
Duration: Initial contract with extension potential

Whitehall Resources are leading ERP Recruitment specialists in the provision of SAP, Oracle & IT recruitment in the UK and Internationally.

All of our opportunities require that applicants are eligible to work in the specified country/location, unless otherwise stated in the job description.

Whitehall Resources are an equal opportunities employer who value a diverse and inclusive working environment. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity or expression, sexual orientation, national origin, pregnancy, disability, age, veteran status, or other characteristics.