Computer System Validation (CSV) Consultant

Overview:

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