Software Quality Engineer

CSV Engineer

General Purpose:

Maintains quality engineering programs, standards and improvements within the organization.

Principle Accountabilities:

• Defines the validation strategy for the V&V Program
• Support to complete all the required CSV deliverables
• Ensures and coordinates the proper execution of all Software V&V activities
• Provides an independent review and approve all the CSV deliverables generated during the Software V&V.
• Responsible to conduct assessments such as Validation Applicability, 21CFRPart11 and Software Functionality Risk Assessment for all software's listed in the IT Architecture
• Reviews test case with trace matrix and ensures adequate test coverage in order to challenge the functionality and to determine if the proposed testing would achieve the purpose.
• Reviews executed protocols and reports for adherence to good record keeping practices and validation practices, and to determine if the conclusions drawn from the reports are justified.
• Provides guidance on how to manage incident/defect handling.
• Supports to identify and forecast the risk and issue with an appropriate solution
• Provide training to the stakeholders and new members in the team on Software Quality aspects and ensures the GDP training records are up to date
• Review and update SOP's and templates to align with regulatory requirements
• Provide internal and external audit support.
• Develops and initiates standards and methods for inspection, testing and evaluation.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
• Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
• Assures data availability and integrity for all quality related data. Consolidates and reports quality results.
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Assists with development and implementation of quality audits.
• Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Analyzes reports and returned products and recommends corrective action.
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
• Approves product, process and equipment qualifications.
• Provides liaison to various regulatory bodies.

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