Job Title :Software Quality Assurance Engineer
Job Family IT Design/Development
Requisition # pare-10032551
Location India – Andhra Pradesh – Hyderabad
Why Work at PAREXEL PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees.
At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You’ll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients.
Job Description Essential Function:
Provide technical expertise, resource, mentoring and leadership for the Software Quality Assurance and Testing activities related to IT-provided application software and systems used by PAREXEL staff in daily business and/or clinical trial activities. In this individual contributor role, the individual will ensure the correctness of functional behavior, usability, maintainability, reliability, fitness for use, operational integrity, quality, stability and performance of all assigned Enterprise and Clinical Systems. This individual will be responsible for all aspects of Software Quality and Testing beginning with functional and design specification reviews through test design and execution, performance testing, regression testing, etc., all the way through system acceptance, maintenance and decommissioning. This individual will also be responsible for mentoring and helping managers and directors develop the skills of more junior members of the IT QA team and other members of IT requesting such development in the areas of Software Quality and Test Engineering.
Key Accountabilities:
• Design test plans, scenarios, scripts or procedures.
• Create or support the creation of test plans and test data, execute approved test plans and report/document results of executed test plans.
• Domain knowledge of clinical and translational research & understanding of research methodology is preferred.
• Working knowledge with clinical applications is preferred.
• Document and manage software defects, using a bug tracking system, and report defects to the respective team members.
• Undertake the full range of duties relevant to ensure that his/her performance meets and/or exceeds both business goals and objectives and his/her own developmental goals and objectives.
• Promote and maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Maintain extensive and open communications with IT development teams and vendor contacts as well as with PAREXEL business system owners and users to ensure priorities and strategy are aligned and understood. Ensure that priorities support the strategic goals of the business.
• Keep manager(s) informed about work progress and any issues to avoid surprises.
• Conduct Software Quality reviews of software functional requirements, logical designs and detailed physical designs.
• Conduct functional, high-level systems integration, performance and change regression testing of in-house developed software and customizations of third-party commercial off the shelf (COTS) software in accord with PAREXEL Operations and PAREXEL Quality Management standards and strategies (e.g., SOPs, lifecycle methodologies and regulatory requirements), project timelines and required quality standards.
• Demonstrate ability to communicate using clinical terminology
• Other responsibilities and accountabilities as required or assigned.
Qualifications Essential Function:
Provide technical expertise, resource, mentoring and leadership for the Software Quality Assurance and Testing activities related to IT-provided application software and systems used by PAREXEL staff in daily business and/or clinical trial activities. In this individual contributor role, the individual will ensure the correctness of functional behavior, usability, maintainability, reliability, fitness for use, operational integrity, quality, stability and performance of all assigned Enterprise and Clinical Systems. This individual will be responsible for all aspects of Software Quality and Testing beginning with functional and design specification reviews through test design and execution, performance testing, regression testing, etc., all the way through system acceptance, maintenance and decommissioning. This individual will also be responsible for mentoring and helping managers and directors develop the skills of more junior members of the IT QA team and other members of IT requesting such development in the areas of Software Quality and Test Engineering.
Key Accountabilities:
• Design test plans, scenarios, scripts or procedures.
• Create or support the creation of test plans and test data, execute approved test plans and report/document results of executed test plans.
• Domain knowledge of clinical and translational research & understanding of research methodology is preferred.
• Working knowledge with clinical applications is preferred.
• Document and manage software defects, using a bug tracking system, and report defects to the respective team members.
• Undertake the full range of duties relevant to ensure that his/her performance meets and/or exceeds both business goals and objectives and his/her own developmental goals and objectives.
• Promote and maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Maintain extensive and open communications with IT development teams and vendor contacts as well as with PAREXEL business system owners and users to ensure priorities and strategy are aligned and understood. Ensure that priorities support the strategic goals of the business.
• Keep manager(s) informed about work progress and any issues to avoid surprises.
• Conduct Software Quality reviews of software functional requirements, logical designs and detailed physical designs.
• Conduct functional, high-level systems integration, performance and change regression testing of in-house developed software and customizations of third-party commercial off the shelf (COTS) software in accord with PAREXEL Operations and PAREXEL Quality Management standards and strategies (e.g., SOPs, lifecycle methodologies and regulatory requirements), project timelines and required quality standards.
• Demonstrate ability to communicate using clinical terminology
• Other responsibilities and accountabilities as required or assigned.
Skills:
• Minimum 1 Year QA/Testing experience in a regulated clinical trial systems / applications.
• Domain knowledge of clinical and translational research & understanding of research methodology is preferred.
• Working knowledge with clinical applications is preferred.
• Familiarity with FDA regulations such as 21 CFR Part 11 and GxP desirable.
• Preference given to candidates with previous and successful validation of Clinical systems/applications and in implementing 21CFR Part 11 requirements.
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