QA Specialist

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. Key Responsibilities   1 Quality Assurance Planning Develop and implement comprehensive QA plans and strategies for safety systems, aligning with industry best practices and company standards. 2. Test Case Development Design, develop, and execute detailed test cases and scripts, ensuring thorough coverage of system functionality and compliance 3. System Validation Conduct rigorous validation of safety systems, including functional, integration, and performance testing to ensure system reliability and 4. Defect Management Identify, log, and track defects, working closely with development teams to ensure timely resolution and retesting of 5. Compliance Assurance Ensure systems comply with regulatory requirements, such as GAMP 5, CFR Part 11, and other guidelines pertaining to drugs, biologics, vaccines, and medical 6. Risk-Based Testing Perform risk-based testing to prioritize test efforts and ensure critical system components meet quality standards. Prepare and maintain comprehensive QA documentation, including test plans, test cases, test scripts, defect logs, and test summary Work collaboratively with project teams, including developers, business analysts, and clients, to understand requirements and ensure quality deliverables. 9. Continuous Improvement Continuously improve QA processes and methodologies, incorporating lessons learned and best practices to enhance the overall quality of deliverables. 10. Client Liaison Act as a liaison between project teams and client process owners to ensure project delivery meets quality standards and 11. Quality Management System (QMS) Create, support, and maintain the Quality Management System, including company policies, procedures, work practices, and work 12. Quality Processes Implement and support quality processes for both on-premises and hosted 13. Change Management Oversee change management processes to ensure controlled implementation of 14. Internal and External Audits Conduct internal audits and support external audits to ensure compliance and identify areas for 15. Safety System Implementations Manage all aspects of safety system implementations, including business configuration, PLSR design, and system 16. 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 17. Root Cause Analysis (RCA) Perform root cause analysis on process deviations and manage quality 18. GAMP 5 and GxP Compliance Maintain compliance with GAMP 5 guidelines and GxP 19. Business Process Review and Optimization Conduct business process reviews and optimize processes to enhance efficiency and 20. Software/Systems Analysis, Design & Development Engage in the analysis, design, and development of software and systems to ensure they meet quality and regulatory 21. CSV and Validation Expertise Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, and GAMP Experience of CSV Validation in core pharmaceutical industry is a Develop validation documentation for pharmaceutical equipment, facilities, and computerized systems used in GLP, GMP Ensure the CSV artefacts are in line with and meet regulatory Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, Worked in V model, SOP, and SDLC Project deliverables will include validation plans, specifications, test protocols, and standard operating procedures for systems, including enterprise IT applications. To provide a planned approach for the implementation of CSV Experience of handling QMS Exposure to regulatory 22. Preferred Experience in Agile Development Knowledge of working in tools like Jira, ServiceNow, HP ALM, and other EDMS tools . Minimum Education Qualification, Specialized Knowledge, and Skills Bachelor s Degree or equivalent, preferably in a science or information technology Minimum of 5 years of professional experience in quality assurance, with specific experience in the pharmacovigilance (PV) Experience in CSV, GAMP 5, CFR Part 11, and V model testing is Technical Skills: Strong understanding of QA methodologies, tools, and Experience with test automation tools and Familiarity with regulatory requirements and guidelines, including GAMP 5 and CFR Part Proficiency in SQL and other relevant Additional Skills: Strong analytical and problem-solving Excellent communication and collaboration Commitment to delivering high-quality solutions and continuous 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. Role: Quality Assurance - Other Industry Type: Pharmaceutical & Life Sciences Department: Quality Assurance Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education UG: Any Graduate PG: Any Postgraduate Key Skills Business processAnalyticalGLPPharmacovigilanceGMPContinuous improvementProject deliverySDLCTestingSQL