Computer System Validation

Job Title

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, client-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

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 stakeholders as necessary

Managing relationships with customers, technical team, quality assurance team, testing team and other stakeholders 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

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 customers