Purpose
The purpose of the role is to be accountable and responsible for the software testing/process and to provide technical guidance to the R&D validation team. The role would engage very early in the project phase, to strategize and plan the complete validation effort. Understand User Requirement Specifications, Involve and assist the team about technical and/or business review of requirements. Ensuring the identification and design of Scenarios, and associated documentation. Bringing out a strategy that includes identification of all test parameters such as environments, test beds, integration scenarios, performance, scalability, load testing, and a plan of resource loading based on the phase of the SDLC. Further, contribute throughout testing life cycle where ever necessary.
Responsibilities- To ensure the integrity of project related systems and tools in accordance with the project defined specifications and internal R&D SOPs.
- To provide accurate and timely updates to Test Lead on progress.
- To participate in the creation and peer review of deliverables of the validation life-cycle.
- To ensure the study and data set up to be made available well in advance.
- To keep current on computer technology to build skill expertise, by attending training courses, seminars, industry association meetings, trade journals and periodicals.
- Need to identify the right environment requirement for validation effort and keep the environment up to date.
- Need to identify appropriate suite of tests required for validation for both functional and regression testing.
- Need to identify the integration points with appropriate scenarios and strategize for execution. Need to look for other possibilities of testing in terms of performance, scalability and load testing where ever required.
- Need to identify and plan with the right resource for application validation.
- Need to come out with the strategy for setting up the data in various ways for both existing and new studies.
- Need to come out with the strategy for arriving at all the possible scenarios that will be tested/covered.
- Need to come out with the strategy for maintaining the tests/test suite for multiple iterations. Need to come out with the strategy to maintain the data set up after single/multiple iterations of test case execution.
- Ensuring the early identification of possible risks with appropriate risk mitigation. To identify regression suite and ensure the successful execution.
- Maintain an up-to-date knowledge of regulations and their practical applicability to SOPs and Clinical IT operations.
- Design, update and/or Implement all SOPs related to validation and testing activities in the R&D group.
- Perform other duties as assigned by management.
- Facilitate the maintenance of the defects for product line, in bug tracking tool.
- Provide status/metrics based on the projects/defects for the team as and when necessary. Provide/facilitate overview, demo of the product/feature implemented to stakeholders upon releases.
- Reporting to the stakeholders on timely basis, which includes daily/Weekly status reports. Mentor team members to achieve project goals.
- Participate in various project and department meetings.
Skills & Competencies- Communication Interacts professionally in an open and honest manner
- Articulates thoughts clearly and effectively Sensitive to the needs of the audience
- Seeks opinions and ideas of others Demonstrates effective oral and written communication as well as commitment to keeping others informed, proactively passing on relevant information to others Quality.
- Ensures that all work meets quality standards and supports others to achieve good quality. Regularly checks work to ensure quality, delivers a quality service and work products on time. Recognizes and evaluates risks appropriately.
- Learning & Development Proactively looks to learn and develop knowledge.
- Accepts feedback constructively and strives to learn and develop from feedback received.
- Keeps up to date with new developments to ensure knowledge of the industry/area of expertise is up to date.
- Planning and Organization Keeps key stakeholders informed of progress, changes. Demonstrates effective teamwork, working with others and supporting colleagues. Is approachable; takes time to assist team members and understand their views and concerns. Collaborates across business units and encourages
others to do the same.
- Driving for Success Demonstrates commitment and enthusiasm to Cenduit and the aims of the company.
- Encourages and supports for others. Takes responsibility for personal outcome. Demonstrates accountability when appropriate.
Technical Competencies- GAMP 4 at Proficient emphasis level Test planning, design and execution at Proficient emphasis level Risk identification and Risk Management at Proficient emphasis level 21 CFR Part 11 - at Proficient
emphasis level Six sigma certification preferred
Education &Experience- Graduate / Post Graduate in Computer Science or equivalent 8+ years experience in Testing practice
- Exposure to Manual and Automation testing Exposure to the use of TFS
