Senior Software Engineer - Validation
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
Purpose of this role is to validate and certify, that the modules developed in R&D are as per the business requirements and documenting the validation activities in accordance with Cenduit Quality standards, meeting the governing regulatory requirements and being responsible for the reliability of the data accepted and information generated by the systems to complete the Validation life cycle.
Responsible to Plan and execute validation activities as required by the SOP’s.
Understanding the URS and Functional Specification documents created as per client requirements.
Discuss and create test scenarios for testing the modules developed.
Responsible for regression testing when new features are implemented or when defects are fixed in the system.
Identify corner cases for testing in coordination with the development team.
Responsible to Log the defects and capture the severity of the defects with all necessary details as applicable.
Verifying the defect fixes with required regression testing.
Provide support to the development team on defect fixating.
Responsible for accessing the system under testing and prove that it is in compliance with that of the 21 CFR Part 11.
Update Methodology Templates as and when required.
Mentor the junior engineer on the functional knowledge of various modules and Domain knowledge.
Responsible to conduct internal gate reviews defined as per the SOP’s for the projects/modules.
Responsible to maintain the quality of the modules/projects.
Identify issues and escalate appropriately to the concerned stakeholders.
Provide support in Internal & External QA Audits.
Ability to analyze the impact on implementing the new requirements.
Ability to understand the user requirements and functionalities.
Able to maintain good work relationship internally within the department and across departments.
Able to well organize the work and make decisions quick and proper.
Able to support project related activities being flexible in working hours.
Able to travel when need arises to meet the business expectation.
Good knowledge/experience in SQL.
Excellent Verbal and written communication skills.
Decision making skills are desired.
Excellent team player and good at group tasking.
Provide necessary domain and functional training.
Education & Experience:
Bachelor Degree in Engineering or related in computer science.
Minimum of 6-7 years of experience in Testing.
Exposure in SDLC.
Knowledge/experience in pharmaceutical/Life sciences/Health care domain with exposure to FDA/ICH/EMA guidelines, GxP and 21 CFR part 11 compliance regulatory would be an added advantage.
Testing certifications would be an added advantage.
Technical skill set requirement:
Excellent exposure to Manual Testing Methodologies.
Good knowledge of SQL required.
Good knowledge of MS Office.
Experience in Testing lifecycle.
Excellent logical testing skills.
Why is Cenduit a great place to work? Visit The Muse to find out more!
Cenduit offers equal employment opportunities without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran or military status and other protected class characteristics.