Job Code: SPH-QA01-2024

QA Specialist

Role Overview

The QA Specialist at Sophos IT Services is responsible for ensuring the quality and compliance of safety systems through rigorous testing, validation processes, and quality management activities. This role involves close collaboration with development teams, business analysts, and clients to ensure that systems meet both functional and regulatory requirements. The position requires a deep understanding of the pharmacovigilance (PV) domain and a commitment to delivering high-quality solutions. This is a remote role, offering flexibility and the opportunity to work from any location.

 Location: Remote

 Key Responsibilities

  • Quality Assurance Planning
    • Develop and implement comprehensive QA plans and strategies for safety systems, aligning with industry best practices and company standards.
  • Test Case Development
    • Design, develop, and execute detailed test cases and scripts, ensuring thorough coverage of system functionality and compliance requirements.
  • System Validation
    • Conduct rigorous validation of safety systems, including functional, integration, and performance testing to ensure system reliability and compliance.
  • Defect Management
    • Identify, log, and track defects, working closely with development teams to ensure timely resolution and retesting of issues.
  • Compliance Assurance
    • Ensure systems comply with regulatory requirements, such as GAMP5, CFR Part 11, and other guidelines pertaining to drugs, biologics, vaccines, and medical devices.
  • Risk-Based Testing
    • Perform risk-based testing to prioritize test efforts and ensure critical system components meet quality standards.
  • Documentation
    • Prepare and maintain comprehensive QA documentation, including test plans, test cases, test scripts, defect logs, and test summary reports.
  • Collaboration
    • Work collaboratively with project teams, including developers, business analysts, and clients, to understand requirements and ensure quality deliverables.
  • Continuous Improvement
    • Continuously improve QA processes and methodologies, incorporating lessons learned and best practices to enhance the overall quality of deliverables.
  • Client Liaison
    • Act as a liaison between project teams and client process owners to ensure project delivery meets quality standards and deadlines.
  • Quality Management System (QMS)
    • Create, support, and maintain the Quality Management System, including company policies, procedures, work practices, and work instructions.
  • Quality Processes
    • Implement and support quality processes for both on-premises and hosted clients.
  • Change Management
    • Oversee change management processes to ensure controlled implementation of changes.
  • Internal and External Audits
    • Conduct internal audits and support external audits to ensure compliance and identify areas for improvement.
  • Safety System Implementations
    • Manage all aspects of safety system implementations, including business configuration, PLSR design, and system configuration.
  • Regulatory Compliance
    • Ensure compliance with FDA, EMA, and PMDA regulations for expedited and periodic reporting, including FDA cGxP, 21 CFR Part 11, EU Annex 11, and MHLW assessments.
  • Root Cause Analysis (RCA)
    • Perform root cause analysis on process deviations and manage quality issues.
  • GAMP 5 and GxP Compliance
    • Maintain compliance with GAMP 5 guidelines and GxP regulations.
  • Business Process Review and Optimization
    • Conduct business process reviews and optimize processes to enhance efficiency and compliance.
  • Software/Systems Analysis, Design & Development
    • Engage in the analysis, design, and development of software and systems to ensure they meet quality and regulatory standards.

Minimum Education Qualification, Specialized Knowledge, and Skills

  • Education:
    • Bachelor’s Degree or equivalent, preferably in a science or information technology discipline.
  • Experience:
    • Minimum of 5 years of professional experience in quality assurance, with specific experience in the pharmacovigilance (PV) domain.
  • Technical Skills:
    • Strong understanding of QA methodologies, tools, and processes.
    • Experience with test automation tools and techniques.
    • Familiarity with regulatory requirements and guidelines, including GAMP5 and CFR Part 11.
    • Proficiency in SQL and other relevant technologies.
  • Additional Skills:
    • Strong analytical and problem-solving skills.
    • Excellent communication and collaboration abilities.
    • Commitment to delivering high-quality solutions and continuous improvement.

This remote QA Specialist role is essential in ensuring the quality and compliance of safety systems, contributing to the overall success of Sophos IT Services by adhering to stringent QA standards and regulatory requirements.

 How to Apply

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