TraceLink
Location
Pune | India
Job description
TraceLink’s software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance, visibility, and decision making. It reduces disruption to the supply of medicines to patients who need them, anywhere in the world.
Founded in 2009 with the simple mission of protecting patients, today Tracelink has 8 offices, over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT. Tracelink is recognized as an industry leader by Gartner and IDC, and for having a great company culture by Comparably. The Validation Specialist role requires a combination of analytical, communication (written and verbal) and interpersonal skills to be successful. Candidate will work closely with a cross-functional team including Product Managers, Software Developers, QA Engineers and Automation Engineers. The target candidate will have QA, validation or testing experience with web applications, as well as familiarity with Microsoft office applications. Responsibilities Synthesize information from requirements specification documents, user stories, and acceptance criteria Author, review, and execute test cases based on requirements, stories, and AC Author and review validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments Review automated test results and provide guidance for test improvement Create and setup test scenarios and test data as needed Work with various teams to promote QA processes, practices and standardization Qualifications 2 to 4 years of experience in the relevant field Bachelors in Computer Science, Computer Information Systems, Information Technology, Engineering, or related discipline. Experience testing web-based enterprise-class business applications Experience Authoring and reviewing Validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments Team mindset with demonstrated enthusiasm and ability to work in highly cross-functional, globally diverse organizations Good time management and organization skills, ability to work independently Experience with MS Office suite Effective written and oral communication skills Ability to work in a fast-paced, dynamic environment; enthusiastic team-player Nice to have Experience in the pharmaceutical industry Knowledge of supply chain business processes including distribution, logistics, warehousing and serialization. Knowledge of FDA regulatory requirements, 21 CFR part 11, and GAMP5 a plusJob tags
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