CSV QA Officer

Computer System Validation (CSV) Officer / Senior Officer within the Quality Assurance (QA) department.In a pharmaceutical injectable manufacturing facility, this role bridges IT/software compliance with strict regulatory standards (such as USFDA, MHRA, and WHO guidelines).Core Job Responsibilities

• Validation & Compliance: Formulate, review, and execute validation protocols (IQ/OQ/PQ) for computerized systems, automated manufacturing equipment, and lab software.
• Data Integrity Assurance: Audit systems to ensure absolute compliance with ALCOA+ principles and 21 CFR Part 11 regulations.
• Risk Assessment: Perform periodic system assessments, gap analyses, and mitigation strategies for software used in the production of injectables.
• Audit Readiness: Maintain audit-ready validation documentation and defend CSV processes during regulatory and client inspections.
• Issue Resolution: Investigate software deviations, track system bugs, and implement Corrective and Preventive Actions (CAPA).