5-7+ years of Computer System Validation (CSV) experience
SOP writing expertise
Familiarity with Veeva systems is a plus
Knowledge of Non-GXP system SDLC
General experience in CSV methodologies
Responsibilities
Author Standard Operating Procedures (SOPs) for validations
Create detailed work instructions for validation tasks
Assist in drafting validation and quality plans for non-GXP systems
Collaborate with the Sr Manager of IT Quality and Validation
Utilize Veeva Quality Docs in validation processes
Benefits
Opportunities to work in a global organization focused on immunology
Engagement in impactful work supporting severe autoimmune disease treatments
Potential for professional growth within IT Quality and Validation
Collaborative work environment with experienced team members
Exposure to cutting-edge technologies like Veeva Quality Docs
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.
