Computer System Validation
16 hours ago
Computer 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 requests Essential 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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Bangalore, Karnataka, India Sartorius Full timeComputer System Validation CSV Professional Join Sartorius as a Senior Computer System Validation CSV Professional and become a key player in driving harmonization compliance and quality assurance within our Confidence Validation Services Quality team In this impactful role you will lead the establishment of a harmonized validation policy ensuring our...
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System Validation Engineer
2 weeks ago
bangalore, 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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System Validation Engineer
16 hours ago
bangalore, 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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Wi-Fi Systems Validation Architect
1 week ago
bangalore, India Intel Full timeArchitects end to end system software for a specific technology, product/platform, or market segment, including software structure and bounding box, firmware, drivers, frameworks, cross component, interfaces/interactions/interoperability, protocols, algorithms, and applications. Responsible for pathfinding and providing the technical direction for software...
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Validation Specialist
2 weeks ago
bangalore, India HCLTech Full timeGreetings from HCL! Currently Hiring for "Computer System Validation” Experience – 3-18 years Location -Chennai/ Hyderabad/ Bangalore/Pune/ Noida Notice period - Immediate to 90 days CTC - Can be discussed JD: Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years’ experience with System Development Lifecyle 3+ years’...
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Pmic Systems And Validation Engineer
3 weeks ago
Bangalore, Karnataka, India Qualcomm Full timeCompany Qualcomm India Private Limited Job Area Engineering Group Engineering Group Hardware Engineering General Summary As a leading technology innovator Qualcomm pushes the boundaries of what s possible to enable next-generation experiences and drives digital transformation to help create a smarter connected future for all As a Qualcomm Hardware Engineer...
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IT Validation Coordinator in Pharma
18 hours ago
bangalore, India Fusion Consulting Full timeCompany Description Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.With over 450 employees and 25 offices worldwide, our mission is to...
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Functional Validation
4 weeks ago
Bangalore, India Jobted IN C2 Full timeAt Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and...
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Verification and Validation
2 weeks ago
bangalore, India Centum T&S Full timeCentum T&S India is a Business unit of Centum Electronics Group offers a wide range of electronic and embedded systems design engineering services to Global Customers to help them realize complex products and sub systems. Centum T&S India (CAI) is an Electronics Design Centre of Excellence, designing for mission critical projects in Aerospace/Space,...
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bangalore, India Sandisk Full timeCompany Description Sandisk understands how people and businesses consume data and we relentlessly innovate to deliver solutions that enable today's needs and tomorrow's next big ideas. With a rich history of groundbreaking innovations in Flash and advanced memory technologies, our solutions have become the beating heart of the digital world we're living in...
