20 Validation Planning Jobs

As the Platform Team Lead for Vehicle Design & Integration (Premium Motorcycles) at Hero Motocorp, you will lead the design & integration team for VED systems for the GB premium/high-performance motorcycle platforms. Your responsibilities will include overseeing Structures, Wheel, Brakes, and Suspension systems, ensuring Vehicle Integration of all components, identifying critical-to-quality parameters, detailing design & release of VED systems, and developing a validation plan to meet customer expectations. You must understand use cases, loading conditions, and translate them into a validation specification, while maintaining HMCL stage gate requirements, regulatory standards, and safety com...

Role Overview: Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY guidelines. Your role involves establishing and maintaining relationships, driving projects to completion with high-quality deliverables, and leading internal initiatives to achieve operational efficiency. Key Responsibilities: - Configure, customize, and deploy Veeva Vault QMS modules (QRM, CAPA, Change Control, Complaints) to align with client-specific quality processes and regulatory requirements. - Design workflows, object lifecycles, security roles, and page layouts to support scalable and compli...

As a Manager - Business Analyst with EY GDS Consulting Enterprise Risk Regulatory Compliance, your primary responsibility will be to lead IT implementation projects in regulated GxP environments, specifically focusing on Veeva Vault applications in the life sciences sector. Your role will involve delivery leadership, stakeholder engagement, and business development support to ensure successful outcomes across Veeva-based solutions for the pharmaceutical lifecycle. **Key Responsibilities:** - Lead end-to-end delivery of Business Analysis workstreams for Veeva Vault Quality Suite, Safety Suite, RIM Suite, Clinical Suite - Drive requirements management, including workshops for as-is/to-be analy...

Execute supplier qualification and certification, and continuously monitor supplier performance through assessments, supplier audits, escape management, supplier performance management and non-conformity resolution. Ensure that suppliers are capable of meeting all requirements for work transfer and process change management including FAI, Resourcing Gate and Production Part Approval Process (PPAP) acceptance. Prepare product and module level quality requirements and co-ordinate with suppliers and internal stakeholders to build confidence that requirements will be achieved. Review, track and monitor component / module development and qualification plan through APQP, including manufacturing an...

As a Supplier Quality Engineer at Hitachi Energy, your role involves executing supplier qualification and certification processes while continuously monitoring supplier performance through assessments, audits, escape management, performance management, and non-conformity resolution. You will be responsible for ensuring that suppliers have the capability to meet all requirements for work transfer and process change management, including FAI, Resourcing Gate, and Production Part Approval Process (PPAP) acceptance. Key Responsibilities: - Prepare product and module level quality requirements - Co-ordinate with suppliers and internal stakeholders to build confidence in achieving requirements - R...

Role Overview: As a Systems Engineer, your role will involve utilizing your knowledge of systems engineering and understanding of vehicle architecture. You will be responsible for writing specifications and validation plans, as well as reading and comprehending specifications to ensure the successful execution of projects. Key Responsibilities: - Gather, analyze, and document system requirements as part of Requirement Engineering. - Create system architectures considering factors such as performance, cost, and reliability in Architecture Design. - Develop test plans for system functionality and performance verification in Validation Planning. - Investigate and resolve technical issues that m...

As a Business Analyst specializing in BOM tools, your role will involve acting as the product owner for BOM tools. This means you will be responsible for understanding business requirements and translating them into product functionality. You will collaborate with the Development team to deploy these features in the tool and gather feedback from the business stakeholders. This continuous loop of development and deployment aims to strengthen and enhance the BOM tools. Your key responsibilities will include: - Creating and proposing new ideas for tool development - Developing business models for tool development - Coordinating with the RNTBCI IS team and providing technical inputs for tool dev...

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior- Business Analyst (Life Sciences IT Systems) At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and deliv...

As a Validation / Certification Engineer, you will be responsible for managing and overseeing the certification process for products, systems, or processes in accordance with industry standards and regulations. Your role will involve coordinating testing, documentation, and compliance efforts to obtain and maintain required certifications. **Key Responsibilities:** - Identify and understand the certification requirements for the product, system, or process under consideration. - Research and finalize standards for EMC/EMI & Safety Testing of products according to the country requirement. - Collaborate with the R & D Team, product development team, quality assurance, and other relevant depart...

As a Validation Lead Engineer at our company, you will play a crucial role in overseeing end-to-end validation activities to ensure regulatory compliance and high-quality execution. Your strategic leadership and hands-on documentation expertise will be key in utilizing a risk-based approach to validation and testing. Key Responsibilities: - Lead validation planning, strategy development, and execution in order to meet project and regulatory requirements effectively. - Prepare and review comprehensive validation documentation, including protocols, reports, and other related deliverables. - Collaborate closely with testing teams to ensure that the execution aligns with requirements and maintai...

As the Platform Team Lead for Vehicle Design & Integration (Premium Motorcycles) at Hero Motocorp, you will lead the design & integration team for VED systems for the GB premium/high-performance motorcycle platforms. Your responsibilities will include: - Overseeing Structures, Wheel, Brakes, and Suspension systems - Ensuring Vehicle Integration of all components - Identifying critical-to-quality parameters - Detailing design & release of VED systems - Developing a validation plan to meet customer expectations You must understand use cases, loading conditions, and translate them into a validation specification while maintaining HMCL stage gate requirements, regulatory standards, and safety co...

As a Business Analyst for BOM tools, your role will involve acting as the product owner for BOM tools. You will be responsible for understanding business requirements and translating them into product functionality. Working closely with the Development team, you will deploy these features in the tool and gather feedback from the business. This continuous loop of developing and deploying tool functionalities aims to strengthen and enhance the BOM tools. Your key responsibilities will include: - Creating and proposing new ideas for tool development - Developing business models for tool development - Coordinating with RNTBCI IS team and providing technical inputs for tool development - Testing ...

Role Overview: As a Systems Engineer, your role involves having knowledge of systems engineering and a general understanding of vehicle architecture. Your experience in writing specifications and validation plans, along with the ability to read and comprehend specifications, will be key to your success in this position. Key Responsibilities: - Gather, analyze, and document system requirements as part of Requirement Engineering. - Create system architectures considering factors such as performance, cost, and reliability in Architecture Design. - Develop test plans to verify system functionality and performance in Validation Planning. - Investigate and resolve technical issues that may arise i...

Role Overview: As a Systems Engineer, you will be required to have knowledge of systems engineering and a general understanding of vehicle architecture. Your role will involve utilizing your experience in writing specifications and validation plans, as well as effectively comprehending specifications to meet the project objectives. Key Responsibilities: - Gather, analyze, and document system requirements through Requirement Engineering. - Create system architectures taking into consideration factors like performance, cost, and reliability in Architecture Design. - Develop test plans for Validation Planning to verify system functionality and performance. - Investigate and resolve technical is...

The Validation / Certification Engineer is responsible for managing and overseeing the certification process for products, systems, or processes in accordance with industry standards and regulations. This role involves coordinating testing, documentation, and compliance efforts to obtain and maintain required certifications. You will be responsible for identifying and understanding the certification requirements for the product, system, or process under consideration. You will research and finalize standards for EMC/EMI & Safety Testing of products according to the country requirements. Collaboration with the R & D Team, product development team, quality assurance, and other relevant departm...

Senior / Lead- Vehicle Engineering Key Responsibilities: Lead and manage the vehicle engineering team, including mechanical, electrical, and systems engineers. Oversee the development of complete vehicle systems from concept through production. Ensure integration of chassis, powertrain, electrical, and software systems.Collaborate with product management, manufacturing, and quality teams to align engineering efforts with busin ess goals. Drive innovation in vehicle design, materials, and technologies.Manage project timelines, budgets, and resource allocation. Ensure compliance with safety, environmental, and regulatory standards. Conduct design reviews, DFMEAs, and validation planning. Mento...

Summary Oversee all aspects of quality management and ensure the highest level of compliance across our projects About The Role Major accountabilities: Oversee & support all areas of quality management for GxP/non GxP Systems. Drive the validation process, including validation planning, testing (IQ/OQ/PQ), and validation reporting. Support Authoring, reviewing, and approving of CSV deliverables for accuracy, consistency, clarity and completeness. Ensuring all the validation SOP/Work Procedures are followed during the application development. Coordinate with project managers and teams to ensure the alignment of project outputs with quality standards. Evaluate data and QM processes to identify...

Lead Oracle Migration Project on DB side Create migration plan, validation plan, and validation report Address performance issues and provide solutions as necessary Cross-verify/recreate DB objects as necessary on the target servers Manage overall DB migration Excellent communication and leadership skills Database decommission experience DBA with hands-on migration experience is mandatory Notice period : Immediate joiner, 15 days or serving NP

Key Deliverables: Develop and maintain validation plans and lifecycle documentation Execute risk-based validation for regulated systems and applications Support change control and continuous validation activities Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 requirements Role Responsibilities: Collaborate with product, design, and QA teams to ensure software readiness Conduct requirement analysis and author validation artifacts Monitor system performance and support incident resolution Maintain validation frameworks aligned with Amgen SOPs and regulatory trends

Supporting Interior & CAB domain activities and deliverables on a project in compliance with QCD commitments. Implementing applicable Train Design Metier instructions, processes & tools. Organisation Reporting Hierarchical Reporting: (Site) Domain Lead (DL) Functional Reporting: (project) Mechanical Lead Engineer (MLE) Accountable for : Planning and piloting Interior & CAB Domain activities and related deliverables on project considering applicable instructions/processes and other specific Customer (internal or external) requirements. Ensuring Interior & CAB Domain deliverables quality and their acceptance by the Customer (internal or external) within committed limits. Reporting activities p...