10 Validation Plans Jobs

Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead ...

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...

Responsible for implementation, and effectiveness of Validation strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, compliance related activities (ICH, 21 CFR, GPDR etc), and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 r...

You are an EV Expert with experience in 400V BMS, Charging Systems, and Battery Pack for locations in Chennai, Bangalore, and Pune. You should have a qualification of B.Tech./M.E./MTech. in Electrical/Electronics. If you meet these criteria and are interested, please share your profile to careers@bluebinaries.com. The preferred notice period ranges from immediate to 60 days. Your responsibilities will include the following: 1. BMS Architecture and System Design (7 to 10 years experience): - Understanding and application of BMS Software - Integration of BMS in Battery Pack & ePWT System - Development of BMS Algorithms and Functional Validation - Validation of BMS on HIL System - Hands-on expe...

You should have a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or a Master's degree in Mechatronics with 4 to 6 years of experience in the field. As part of your role, you will be responsible for designing, developing, and validating steering systems for heavy commercial vehicles (HCVs). Your key qualifications should include a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and components, experience in preparation and validation of specifications, proficiency in 3D/2D CAD tools such as CATIA, and hands-on experience in Casting/Forging manufacturing design. Additionally, you should have experience with tolerance stack-up analysis, DFMEA, v...

You should possess a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or M-Tech in Mechatronics with 4 to 6 years of experience. As a member of our team, you will be responsible for the design, development, and validation of steering systems for heavy commercial vehicles (HCVs). Your role will require a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and their components, such as torque sensors, actuators, and steering columns. You should have experience in preparing and validating specifications and be proficient in 3D/2D CAD tools like CATIA. Hands-on experience in Casting/Forging manufacturing design, tolerance stack-up analysis, and DFMEA i...

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, a...

As an experienced professional with over 3 years of experience in Computer Systems Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, and medical devices, you will be responsible for the following key tasks: - Developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. - Conducting risk assessments and gap analyses to identify potential quality issues and implementing corrective actions as necessary. - Developing and maintaining quality documentation including Standard Operating Procedures (SOPs), validation plans, test cases, and reports. - Participating in t...

ABOUT THE ROLE Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including ...