Role Descriptions:
• Demonstratable Experience in Computer System Validation (CSV)
• Experience in software development processes (SDLC) and software testing life cycle (STLC)
• Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation.
• Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI
• Strong knowledge of JIRA, HP-ALM, qTest tools
• Knowledge of validation & testing in projects implemented using agile methodology
• Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc.
• Ability to take and understand the commitment to deliver the product on time.
• GxP experience is required
• Experience of validation support for 21 CFR Part 11 implementation in Pharma industries.
• Leading the Tech Writer team for preparing the test cases.
• Co-ordinating the testing with the business and automation test teams.
• Experience working within a FDA/Other regulated pharma industry.
Roles & Responsibilities:
• Meeting with system users to understand the scope of projects
• Participating in business requirement discussions to draft SDLC /CSV /Qualification documents.
• Developing validation/qualification/migration/verification strategies for software
• Executing validation/qualification/verification/migration strategies per quality assurance SOPs..
• Providing validation/verification/qualification recommendations to stake holders as necessary.
• Managing relationships with customers, technical team, quality assurance team, testing team and other stake holders to ensure the validation/ verification/qualification solution delivered to the customer meets expectations.
• Ensuring SDLC/CSV/Qualification activities are conducted as planned
• Generate, review, and Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports etc.
• Working towards project deadlines
• Communicating findings to technical and non-technical colleagues.
• Liaising with project teams in other parts of the world
• Leading the validation effort.
Generic Managerial Skills, If any
• Strong verbal and written communication skills with the ability to liaise with a variety of stakeholders
• Must be self-motivated and pro-active
• Need to show constant dynamism and able to manage pressure.
• Attention to detail
• Competent CSV skills
• The ability to work in a team and individually
• Organizational skills with the capability of working towards tight deadlines
• Able to work with demanding customer
Computer System Validation (CSV) Consultant • Raritan, NJ, New Jersey, USA
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