Qualis1 Inc. · 1 day ago
Computer System Validation Consultant (Pharmaceutical)
Indianapolis, IN
Contract
Onsite
Senior Level
$40/hr - $40/hr
5+ years expQualis1 Inc. is seeking a Computer System Validation (CSV) Consultant to act as a Compliance Lead in a regulated pharmaceutical environment. The consultant will work independently and partner with client stakeholders to ensure IT systems meet FDA and global regulatory compliance standards using a risk-based validation approach.
Staffing & Recruiting
Hiring Manager
Syed Mohiuddin Asadi
Responsibilities
Act as a client-facing Compliance Lead for validation initiatives
Provide quality and compliance guidance to IT and project teams
Apply risk-based validation and right-sizing approaches
Own project deliverables and ensure on-time, compliant execution
Monitor and guide offshore/offsite teams to meet milestones
Ensure strict adherence to internal and external compliance processes
Meet contractual quality and regulatory expectations
Qualification
Required
5+ years as a Computer System Validation Consultant in a regulated environment (Pharma preferred)
Prior experience working in Pharmaceutical QA/QC within manufacturing
Strong knowledge of FDA and global regulatory requirements (GxP)
Proven ability to lead validation activities independently with minimal guidance
Strong technical writing skills (validation plans, protocols, reports)
Excellent verbal and written communication skills
Hands-on experience with MS Office and Adobe documentation tools
Preferred
Risk management and supplier/vendor assessment
Auditing experience
Experience working with global/virtual teams
Exposure to cloud-based systems in regulated environments
Company
Qualis1 Inc.
At Qualis1 Inc., our robust business model is strategically built upon serving diverse industry sectors, including Finance, Health Care, Education, State Government, and Manufacturing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase