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Sophos IT Services

Compare

2.0

based on 1 Review

11 Sophos IT Services Jobs

QA Specialist

Sophos IT Services

2.0

based on 1 Review

5-10 years

Remote

1 vacancy

QA Specialist

Sophos IT Services

posted 3mon ago

Job Role Insights

Key skills for the job

Manual Testing Pharmacovigilance SQL Analytical Chemistry Business Process Management Continuous Improvement

+ 4 more

Job Description

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.

Employment Type: Full Time, Permanent

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