Senior Test Engineer-Validation-R&D

Cenduit provides interactive response technology (IRT) - driven services for clinical trials around the world. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and clinical supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific. Cenduit's Software as a Service (SaaS) IRT solutions deliver optimized clinical supply chain management and facilitate precise control over patient randomization and drug administration to enable more efficient, compliant trials. With expert personnel located across the globe, Cenduit's unprecedented level of support currently covers more than 32,000 sites in more than 100 countries.

Overview:
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.
Primary Responsibilities:
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.

Skills:

Ability to analyzes 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 organise 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 and 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 Skills Set and 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.


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