[3 Days Left] Computer System Validation

Job Description About Company : They balance innovation with an open, friendly culture and the backing of a long-established parent company, known for its ethical reputation. We guide customers from what's now to what's next by unlocking the value of their data and applications to solve their digital challenges, achieving outcomes that benefit both business and society. About Client: Our client is a global digital solutions and technology consulting company headquartered in Mumbai, India. The company generates annual revenue of over $4.29 billion (35,517 crore), reflecting a 4.4% year-over-year growth in USD terms. It has a workforce of around 86,000 professionals operating in more than 40 countries and serves a global client base of over 700 organizations. Our client operates across several major industry sectors, including Banking, Financial Services & Insurance (BFSI), Technology, Media & Telecommunications (TMT), Healthcare & Life Sciences, and Manufacturing & Consumer. In the past year, the company achieved a net profit of $553.4 million (4,584.6 crore), marking a 1.4% increase from the previous year. It also recorded a strong order inflow of $5.6 billion, up 15.7% year-over-year, highlighting growing demand across its service lines. Key focus areas include Digital Transformation, Enterprise AI, Data & Analytics, and Product Engineeringreflecting its strategic commitment to driving innovation and value for clients across industries. Job Title: Computer System Validation (CSV) Expert Location: Bengaluru Experience: 5+ yrs Job Type: Contract to hire(Min 1+ yr) Notice Period: Immediate joiners Job Description: Key Responsibilities: Perform validation activities for software tools such as Atlassian suite (JIRA, Confluence, Crowd), ELM Suite (RQM, DNG), Windchill, JFrog Artifactory, GitHub. Create and maintain validation documentation including test protocols, plans, reports, Change Requests, Validation Plans, Risk documentation, etc. Draft and update procedural documentation in compliance with GxP standards and obtain necessary approvals. Execute validation scripts and manage formal testing processes for GxP systems. Handle user access management and admin requests for tools like JIRA, RQM, and GitHub. Manage tool-related service admin requests via ServiceNow. Support change control, lifecycle management, and impact assessments for CSV tools. Collaborate with cross-functional teams (e.g., SQM) to ensure compliance and audit readiness. Ensure compliance with 21 CFR Part 11 and other GxP regulatory standards. Apply data integrity principles to all validation and documentation activities. Develop and maintain validation documentation such as URS, FRS, IQ, OQ, and PQ. Implement risk-based validation approaches to optimize compliance efforts. Manage change control, deviation handling, and CAPA processes effectively. Validate software tools used in regulated environments to ensure compliance and functionality. Provide support during audits and inspections, ensuring readiness and documentation accuracy. Knowledge on tools like RQM, DNG, JIRA, Confluence, JFrog Artifactory, and GitHub at both user and admin levels is a added benefit. Below are the Must-Have and Good-to-Have requirements extracted from the job description (JD) Must-Have Primary Skills: Strong understanding of CSV (Computer System Validation) principles and lifecycle Experience with GxP systems and regulatory compliance (e.g., 21 CFR Part 11, GxP Standards) Basic understanding of data integrity principles Hands-on experience in validation documentation: URS, FRS, IQ, OQ, PQ Familiarity with risk-based validation approaches Knowledge of change control, deviation management, and CAPA processes Experience in validating software tools used in regulated environments Ability to work with cross functional teams(SQM) to ensure compliance Good-to-Have Skills: Familiarity with tools like RQM, DNG, JIRA, Confluence, JFrog Artifactory, and GitHub (user/admin level) Exposure to audit processes