Computer System Validation
1 day ago
Computer System Validation Experience: 5 to 10 Years Location: Bangalore Notice Period: Immediate to 15DaysPrimary Function of Position This positions primary role is to work closely with the internal IT teams and cross functional departments Business PQCSV to support computer system validation activities related to projects and change requestsEssential Job Duties Responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle ensuring compliance with regulatory requirements Computer Systems Validation CSV and Lifecycle procedures with Data Integrity requirements Provide oversight of validation activities lead the development and approval of validation documentation and risk assessments work with project teams to determine which elements should be validated and conduct impact assessment of proposed changes to computerized systems Perform and or direct GxP computerized system validation projects in compliance with 21 CFR 820 21 CFR Part 11 Annex 11 and Data Integrity Ensure that GxP systems meet intended uses and comply with applicable regulations current industry practices and Intuitive Surgical policies and procedures Development and approval of Validation Plans IQ OQ Protocols Trace Matrices Risk Assessments and Validation Summary Reports Establish validation standards develop testing protocols document test results and maintain records for later analysis Documentation and remediation of deviations resulting from validations qualifications Provide assistance and guidance in training coworkers on validation protocols and operating procedures Author Update assigned Operating Procedures SOPs DOPs Policies validation templates to ensure compliance with Company policies and federal regulations Support regulatory agency inspections audits as required Must be familiar with cGMPs and current industry guidelines Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules Maintains awareness of regulatory requirements Understanding of FDAs new guidance of CSA risk based approach validationRequired Skills and Experience Bachelors degree BS in related field or equivalent 58 years hands on experience in Computer System Validation Quality Compliance in a FDA Regulated industry Medical Device Pharma Life Sciences with a focus on GxP system Knowledge of fundamental cGMP concepts and FDAEMA regulations QSR 21 CFR Part 820 21 CFR Part 11 and ISO 9001 Standards Strong knowledge of FDA Regulated manufacturing processes process validation computer and equipment validation and GMPs Hands on experience in EDMS Electronic Document Management system Test Management tools Understanding of FDAs recent guidance on transition of CSV to CSA Ability to develop clear concise and timely oral and written reports Excellent written and oral communication skills Ability to work on complex projects with general direction and minimal guidance Ability to handle multiple projects and meet deadlines Ability to manage priorities and workflow Versatility flexibility and a willingness to work within constantly changing priorities with enthusiasmPreferred Skills and Experience Hands on experience with Microsoft word Excel PowerPoint Visio Hands on experience with EDMS Electronic Document Management system Test Management tools
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Computer System Validation
23 hours ago
Delhi, India LTIMindtree Full timeComputer System ValidationExperience: 5 to 10 YearsLocation: BangaloreNotice Period: Immediate to 15DaysPrimary Function of PositionThis positions primary role is to work closely with the internal IT teams and cross functional departments Business PQCSV to support computer system validation activities related to projects and change requestsEssential Job...
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Computer System Validation
2 weeks ago
Delhi, India RMP ITlorist Technologies Full timeConduct risk & impact assessment to determine the extent of validation and qualification - Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems - Implementation of organizational IT controls in accordance with applicable regulations and the...
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System Validation Engineer
1 week ago
New Delhi, India L&T Technology Services Full timeRole Overview:As a System Validation Engineer, you will be responsible for setting up and maintaining x86 and Chip SoC platforms for functional validation. This includes configuring hardware, software, and thermal solutions, and ensuring stable system operations across multiple environments.Key Responsibilities:- Set up x86 and Chip SoC platforms for...
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Validation Engineer
7 days ago
New Delhi, India Agilisium Consulting Full timeWe are seeking a Validation Lead with strong expertise in Computer System Validation (CSV) and SQL-based data validation to support our Life Sciences programs. The ideal candidate will also bring emerging Gen AI knowledge to help shape validation strategies for AI-enabled cloud-based systems.- Define validation strategy, author and review validation...
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Validation Specialist
7 days ago
New Delhi, India HCLTech Full timeGreetings from HCL!Currently Hiring for "Computer System Validation”Experience – 3-18 yearsLocation -Chennai/ Hyderabad/ Bangalore/Pune/ NoidaNotice period- Immediate to 90 daysCTC - Can be discussedJD:- Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years’ experience with System Development Lifecyle 3+ years’...
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Validation Specialist
3 days ago
New Delhi, India HCLTech Full timeGreetings from HCL!Currently Hiring for "Computer System Validation”Experience – 5-12 yearsLocation -Chennai/ Hyderabad/ Bangalore/Pune/ NoidaNotice period- Immediate to 30 daysCTC - Can be discussedJD:Proven experience in software validation in GxP environments and21 CFR Part 11 compliance.Well experienced in IQ, OQ, and PQ protocolsPrior experience of...
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Embedded Developer
3 weeks ago
Delhi Division, India SEMI LEAF Full timeJob Description :- Responsible for deep understanding, architecting, and implementing complex System Validation frameworks involving custom device drivers for hardware and firmware solutions (e.g., storage devices like SSD).- Responsible for designing algorithms to simulate complex real-world field & Skills :- Mandatory expertise in PCIe, NVMe / storage...
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Functional Validation Engineer
4 weeks ago
New Delhi, India Capgemini Engineering Full timeFunctional Validation Engineer Location:Bangalore Experience:4–9 years Notice Period:Immediate to 30 daysChoosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...
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Functional Validation Engineer
4 weeks ago
New Delhi, India Capgemini Engineering Full timeFunctional Validation EngineerLocation: BangaloreExperience: 4–9 yearsNotice Period: Immediate to 30 daysChoosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...
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Functional Validation Engineer
1 day ago
New Delhi, India Capgemini Engineering Full timeFunctional Validation EngineerLocation:Bangalore Experience:4–9 years Notice Period:Immediate to 30 daysChoosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...
