Validation Engg-Somerset,NJ

13 Nov 2024

Vacancy expired!

Provide testing and validation effort estimation by analyzing the requirements and performing impact analysis Work with development team, PMO and system analysts to analyze the system impact and provide testing strategies. Lead system integration testing with vendor or client. Interpret project specifications, and develop comprehensive testing cycle to ensure that each deliverable conforms to project specifications and client expectations Understand key functionality enhancements and guide fellow testers to create comprehensive testing scenarios. Analyze incoming data and client files for accuracy, completeness, and applicability Ensure contents and structure of all regulatory artifacts are documented and maintained for Audit purpose Requires frequent and detailed interaction with system analyst, IT Managers, Solution architect, and project manager to ensure that each deliverable meets or exceeds client expectations. Write automation test cases and performed API test automation using postman / .Net and Selenium. Perform Internal audit on the validation projects and systems Conduct software validation focusing on GAMP, 21 CFR Part 11, PDMA and HIPAA assessments on off-the-shelf software. Apply the knowledge and expertise obtained in Pharmaceutical industry and Engineering to Lead Software Validation Projects. Develop and review IQ/OQ/PQ protocols for test execution. Create and review Acceptance Test Plan, Requirements Traceability Matrix, Deviation/Issue Report and Validation summary Report. Ensure proper compliance of all validated project by reviewing and approving applicable documentation Aid Director in assessing departmental productivity and identify opportunities for improvements. Provide guidance to internal departments in system validation, HIPPA security and 21 CFR Part 11 requirements Interface with management and the business side regarding updates, questions, and problems, as needed Maintain a high degree of business functional knowledge. Strong knowledge on Test Engineering process (i.e. CMMI) and should possess a thorough understanding of the Agile Methodology and SDLC. Solid understanding of SQL to develop queries and/or execute. Conducting periodic reviews of validated systems Ability to lead and manage according to changing demands and priorities. Responsible for the production deployment approval of all testing deliverables and achievement of testing milestones during a project. Looks for ways to improve and promote quality; Applies and implement best practices accordingto feedback to improve performance.

  • ID: #22671019
  • State: New Jersey Somerset 08873 Somerset USA
  • City: Somerset
  • Salary: USD TBD TBD
  • Job type: Contract
  • Showed: 2021-11-13
  • Deadline: 2022-01-11
  • Category: Et cetera