5-7+ years of experience in Computer Systems Validation (CSV)
Proficient in SOP writing and creating work instructions
Experience in validating non-GXP computer systems preferred
Familiarity with Veeva Quality Docs is a strong plus
Knowledge of software development lifecycle (SDLC) for commercial and financial systems is advantageous
Responsibilities
Author standard operating procedures (SOPs) for validation processes
Create detailed work instructions to guide compliance and quality assurance
Assist in the development of validation and quality plans for non-GXP systems
Collaborate with the Sr Manager of IT Quality and Validation
Utilize Veeva Quality Docs for documentation and reporting tasks
Benefits
Opportunity to work with a leading global immunology company
Engage in meaningful work that impacts patients with severe autoimmune diseases
Collaborative work environment with experienced professionals
Potential for professional growth and development in IT quality and validation
Full Job Description
Responsibilities:
Our client is a global immunology company committed to improving the lives of individuals who have severe autoimmune diseases with their Client antibody-based medicines.
They are currently seeking a Computer Systems Validation (CSV) resource to author SOPs, create work instructions, assist in writing validation and quality plans for non-GXP systems.
This role reports into the Sr Manager of IT Quality and Validation.
This client uses Veeva Quality Docs and therefore experience with Veeva is a plus.
Requirements:
General Computer System validation experience
Veeva validation experience is a plus.
Knowledge in Non- GXP computer system SDLC (commercial, financial systems etc..) is a plus.
