Computer System Validation - CSV Lead

Job Description

If you are interested in applying for this job, please make sure you meet the following requirements as listed below.

The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment.

The QA Validation Lead provides compliance guidance to InClin business leadership and CSV System stakeholders.

Responsibilities

• Lead and oversee the Validation and Qualification processes for GxP Computer Systems and infrastructure, to ensure adherence to 21 CFR Part 11 Compliance, GAMP-5, EU Annex 11, and other relevant regulations.
• Recommend and review system-level configuration to fulfill security, data integrity, and regulatory requirements.
• Design Configuration Specifications (CS) in sandboxes and implement them into Validated Systems.
• Write, review, and approve CSV assessment documents, including GxP Computer System Risk Assessments, Part 11 Annex 11 Compliance Assessments, and GxP Computer System Data Integrity Assessments.
• Lead installation and testing activities including writing and overseeing Installation Qualification (IQ) Protocol and scripts, Operational Qualification (OQ) Protocol and scripts, Performance Qualification (PQ / UAT) Protocol and scripts, and Requirements Traceability Matrices (RTM).
• Author and approve Validation Plans and Validation Summary Reports.
• Document, evaluate, manage, and log GxP Computer System Change Control Requests (CCRs).
• Maintain an inventory of GxP Computer Systems, assess Validation status, and prioritize actions based on risk.
• Retire and archive IT GxP Computer Systems including retirement / migration planning and writing retirement summary reports.
• Provides input into IT procedures, Work Instructions (WIs), Guidance Manuals (GMs), and training materials for developing, maintaining, and using GxP Computer Systems.
• Evaluates potential new Computer Systems or software for GxP impact and provide risk-based Validation guidance.
• Review incidents and changes to Computer Systems for GxP impact, identifying and executing necessary Validation or Qualification requirements.
• Conduct and perform periodic reviews of GxP Computer Systems and user access to ensure ongoing compliance with regulatory standards and readiness for audits.
• Performs and / or assists with Qualification Audits of GxP IT System Service Providers to ensure that these organizations are operating in a compliant manner and maintaining the required quality standards.
• Maintain Master Validation Plan for company computerized systems.
• Develops / improves validation programs as needed to remain current with cGMPs and industry standards
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot, and maintain systems, equipment and processes.
• Conducts and / or participates in deviation investigations to identify root causes and define corrective and / or preventative actions (CA / PA).

Requirements

• Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations).
• Bachelor's degree or equivalent experience in computer science, information technology, or a related field.
• Minimum of 5 year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
• Installation, Operational and Performance Qualification protocol generation and execution experience
• Excellent technical writing and verbal communication skills.
• Good communication skills and leadership skills.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• High degree of proficiency in Microsoft Office Suite and Smartsheet
• Detail-oriented with a strong analytical mindset and problem-solving capabilities
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously

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