Serving more than 350 customers in 35+ countries, Xybion has the global scale and expertise to bring employees around the world together to drive the digital transformation of laboratories. Xybion is a leading ai enabled software as a service company dedicated to helping corporations solve business problems through intelligently designed software products and business processes. We help companies become more efficient, reduce costs and manage compliance, regulatory adherence, and risk.
Our unique solutions focus on integrated preclinical lab management LIMS, all lab LIMS, ELN, QMS, and Risk Prediction software’s. Xybion Consulting offers Design Thinking, Business Analysis, PMO, Risk & Compliance services and computer systems validation. Since its founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies. You can learn more about our solutions here: https://www.xybion.com
Role: Senior Test Engineer
Location: Chennai & Pune, India
The Senior test Engineer participates in Quality Control stage testing and evaluation of Xybion or third-party software products either independently or as a team member or leader. They may also create test scripts or test cases to be traceable to defined functional requirements of each applicable product and may also be responsible for review and approval of test cases created and/or executed by other Testers. The Senior Tester must be able to work independently and must be able to supervise the work of other Testers as part of a team working either internally or externally on behalf of a Xybion client.
Key Responsibilities:
- Write and review quality test cases based on product functional requirements and in accordance with applicable standard operating procedures
- Ensure validation documentation (OQ/IQ/PQ) meets industry standards (21 CFR Part 11, GxP, FDA guidelines).
- Execute test cases according to instructions and in compliance to Good Documentation Practices
- Report and assist in resolution of issues encountered during testing
- Analyze/triage issues encountered during testing, both of own testing and others’, and escalate appropriately when required.
- Supervise work of other testers
- Testing may include but is not limited to Regression Testing, Adhoc Testing, Smoke Testing, Performance Testing Other duties as assigned
- Minimum of 4+ yrs experience in software testing under an SDLC designed for pharmaceutical or similar regulatory compliance.
Prior experience supervising teams of personnel helpful.
Prior work experience in FDA-regulated environment helpful. - Proficient working in Microsoft Office applications
Knowledge of domain and applications being tested
In-depth understanding of FDA GMP/QSR regulations and associated requirements for electronic records and Good Documentation Practices
In-depth understanding of validation expectations for FDA regulated companies.
Bachelor’s degree in a scientific, regulatory, or technical discipline, or Associates degree and minimum of 3 years previous work experience in regulated industry. Equivalent prior work experience may substitute for degree requirements at discretion of Manager.
Compensation:
We offer highly competitive compensation, including base salary, commission/ performance-linked bonus, along with a comprehensive benefits package.
We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.
Xybion is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by fede
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What We Do
Digitize - Transform - Innovate
Xybion is a Digital Acceleration cloud platform company with end-to-end all-inclusive Solutions for business processes for highly regulated industries with embedded Quality and Predictive Compliance with Real-Time Monitoring unified on a Single Platform to Help You Manage Your Entire Business Process Seamlessly. Personalize Our Preconfigured Apps or Let us Rapidly Configure New Apps On Our Low-Code XDP Platform To Your Specifications. Your Process- Your Way.
Our out-of-the-box solutions include:
• R&D Execution System: Gold Standard for End-to-End Discovery, Preclinical Research, Development, SEND & Submission.
• Digital Lab Execution System: Quality & Compliance Embedded Cloud-based LIMS, ELN, Scientific Data & Total Laboratory Process Management
• Total Predictive, Quality, Compliance & Risk Management: Total Predictive Compliance, Quality, Risk & Real-time Data Integrity Compliance Monitoring
• Workplace Health and Safety, Medical Care, Case, Compliance & Claims Management: One cloud connecting all stakeholders in a single database.
• Enterprise Content Management: Document Creation, Review, Imaging, Annotation Unified with Core Business Processes and with Quality and Compliance Systems
Xybion has over 160 clients in 29 countries including all of the top 20 biopharmaceutical companies.
