Quality Assurance CSV Specialist

Job Summary

A company is looking for a Contract, Quality Assurance - Computer System Validation (QA CSV).

Key Responsibilities

• Write, review, and approve CSV documents including Validation Plans and Test Scripts
• Act as the QA CSV point of contact and Subject Matter Expert for validation and Quality Risk Management
• Perform quality reviews and audits related to computer systems and ensure compliance with regulatory standards

Required Qualifications

• Bachelor's degree in a relevant field and a minimum of 6 years of experience in a pharmaceutical or biotechnology environment
• At least 3 years of experience in GxP Computer System validation
• Hands-on knowledge of GxP regulations and guidelines related to CSV
• Experience with SAP projects is required
• ASQ CQA certification is desired but not mandatory