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QA Specialist III (3796)

Company: Execu-Search Group
Location: Somerville
Posted on: January 9, 2021

Job Description:

Job Title: Computerized Systems Validation Lead (QA) The role of CSQA lead provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices. This is accomplished by --- Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners. --- Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities. --- Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s). --- Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s). --- Providing validation/verification/qualification guidance to stake holders as necessary. --- Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations. --- Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner. ACCOUNTABILITIES: --- Subject Matter Expert on Takeda---s SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business. --- Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across Takeda. --- Oversee the validation/verification/qualification strategy development by working with the validation team. --- Work with project team---s offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements. --- Ensure the project testing scope is met per specified agreement and/or scope change. --- Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression. --- Thoroughly understands the difference between Positive versus Negative Testing. --- Insure all SDLC deliverables are completed and stored appropriately. --- Leads resolution efforts when issues are identified and escalate appropriately. --- Actively share emerging industry standards/trends with customers and peers within area of responsibility. --- Guide the response and remediation of corrective actions and internal audits. --- Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks. --- Proactively identify and assist in prioritizing opportunities to streamline validation and or qualification efforts but still stay compliant. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: --- Bachelor---s degree in a life science or computer science required; Master---s degree in management or scientific discipline a plus. --- At least 10 years of pharmaceutical experience. --- Broad experience in computer system life cycle development/computer system validation in R&D. --- Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.Type: ContractCategory: LIFE

Keywords: Execu-Search Group, Somerville , QA Specialist III (3796), Other , Somerville, Massachusetts

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