Job Description

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VALIDATION is MUST, preferably in Life Science . EXP in process optimization in automated test environment. GOOD knowledge in software development life cycle ( SDLC ). EXP in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guideline and FDA regulations on COMPUTER SYSTEM VALIDATION . Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICH and FDA. Coordinating multiple validation and qualification activities with project teams, various departments and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments. Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11 to client personnel. Representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/https://g.co/kgs/UAsF9W