1203 Validation Jobs - Page 12

Work Your Magic with us! Ready to explore, break barriers, and discover more We know you've got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. The Manufacturing Site Quality Head plays a pivotal role in shaping the strategic direction of the organization by ensuring that all products meet the highest standards of quality and compliance....

Planning and performing of Computer Systems Validation in regulated environment. Respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. IT systems interface Required Candidate profile Working knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Develop CFR Part 11 csv plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols; IT system interface

Role Overview: As a skilled PLM Software Quality & Validation Engineer at Amgen, your primary responsibility will be to develop, execute, and maintain test scripts for 3DEXPERIENCE PLM platforms and custom-built solutions. You will play a crucial role in ensuring that the PLM solutions adhere to required validation processes, documentation, and comply with Amgen's standard operating procedures. Your expertise will be instrumental in guaranteeing quality and adherence to standards, enabling the engineering teams to build and deploy compliant products efficiently. Key Responsibilities: - Work on various types of testing including Functional, System, Stress, Performance, Integration, Regression...

As a Senior Executive / Assistant Manager in the role of Utility Engineer at Ankleshwar, you should have a B.E (Mechanical) qualification and 10 to 15 years of experience in the API industry. Your responsibilities will include: - Operation and Maintenance of Chilled water plants. - Operation and Maintenance of Chilled Brine plants. - Operation and Maintenance of Natural gas fired boiler. - Operation and Maintenance of Nitrogen generation plant. - Operation and maintenance of Air compressors. - Operation and maintenance of Air dryers. - Operation and Maintenance of cooling towers. - Potable water storage and distribution. - Process water Operation, Generation, and distribution including sched...

As a Data/Information Management Senior Analyst at Citigroup, you will be a seasoned professional applying in-depth disciplinary knowledge to contribute to the development of new techniques and processes within the defined area. You will integrate subject matter and industry expertise to evaluate moderately complex issues with substantial potential impact. Your role will involve weighing various alternatives, balancing conflicting situations, and providing advice and counsel to influence decisions within your area of specialization. Your analytical skills will be essential in filtering, prioritizing, and validating complex and dynamic material from multiple sources. Your excellent communicat...

As an IAC Tester, your role will involve testing Terraform scripts to ensure reliability and compliance with organizational standards. You will collaborate with cross-functional teams to define infrastructure requirements and automate infrastructure provisioning, scaling, and management processes using Terraform. Your focus will be on designing, implementing, and managing Terraform configurations with pre-post validation and custom checks. Key Responsibilities: - Automate infrastructure provisioning, scaling, and management processes using Terraform. - Collaborate with cross-functional teams to define infrastructure requirements and ensure alignment with best practices. - Design, implement, ...

As a Business Analyst, you will play a crucial role in understanding the Software Development Life Cycle (SDLC) and Business Process Flows. Your solution-oriented approach, combined with practical knowledge of the BA discipline, will be instrumental in eliciting, analyzing, validating, specifying, verifying, and managing the business needs of clients and stakeholders. You will be responsible for documenting these requirements in the appropriate Business Requirement Document. Key Responsibilities: - Documenting clients" Business requirements and Change Requests into appropriately formatted Functional Requirement documents, Wireframes/Mockups, Use cases, etc. - Communicating effectively with c...

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - E...

Role Overview: You will be responsible for supporting the design and development of new electric motor prototypes and assemblies. You will read and interpret engineering and technical drawings for development and production purposes. Additionally, you will assist in mechanical assembly, testing, and validation of products. Collaboration with cross-functional teams including design, production, and quality is essential to ensure quality standards and design specifications are met throughout the development cycle. Your contribution to continuous improvement in NPD workflows and documentation is highly valued. Working closely with the quality control (QC) team to handle any rejections or deviat...

As a Quality eCompliance professional at Piramal Pharma Solutions, your role will involve ensuring regulatory compliance of Laboratory Information Management System (LIMS) at Global Piramal Pharma sites. Your key responsibilities will include: - Having a good understanding and knowledge of LIMS application functionalities and its integration with other systems. - Providing SME support for the implementation of LIMS across sites and supporting key decisions for system workflow changes from Quality and e-compliance perspective. - Supporting the validation of LIMS application and other enterprise systems to comply with regulatory guidelines. - Defining validation strategy and providing inputs t...

Role & responsibilities The Executive QA Validation will be responsible for executing and ensuring compliance of validation activities in the Injectable (Sterile) manufacturing facility, including equipment, utilities, cleaning, process, computerized systems, and analytical methods. The role requires adherence to cGMP, regulatory guidelines, and internal SOPs to ensure that all validation practices support product quality and regulatory requirements. Key Responsibilities: Execution and review of validation activities for sterile injectable dosage forms, including: Equipment Qualification (IQ/OQ/PQ) Utility Qualification (HVAC, Water Systems, Compressed Air, Clean Room Validation) Process & C...

As an Embedded Firmware & Software Intern/Fresher at our company in Ahmadabad, you will be part of a dynamic team working on developing innovative solutions in embedded technology. Your role will involve the following key responsibilities: - Assisting in the design, development, and debugging of embedded firmware for microcontrollers and embedded devices. - Working with communication protocols such as I2C, SPI, UART, and CAN. - Writing and maintaining embedded C/C++ code for various microcontroller platforms like ARM, PIC, AVR, and STM32. - Participating in hardware testing, validation, and troubleshooting of circuits and firmware. - Collaborating with hardware engineers to bring up new hard...

Role Overview: As a Senior Simulation Engineer specializing in Thermal Management at ENNOVI, your primary responsibility will be to provide simulation support for the Energy product line, focusing on thermal management of the CCA and battery packs. You will conduct detailed thermal simulations and analyses using state-of-the-art software tools to ensure optimal product functionality and reliability. Your role will also involve collaborating with cross-functional teams, laboratories, external customers, and suppliers to enhance thermal management enhancements and develop new technology simulations related to ENNOVI products. Key Responsibilities: - Provide simulation support for the Energy pr...

As an Officer in the Research & Development-Analytical Development Laboratory, your role will involve performing various analytical tasks. Your key responsibilities will include: - Performing Analysis on HPLC - Operating Dissolution apparatus - Conducting Related substance Analysis - Working on Analytical method development and Validation To qualify for this position, you should have: - Minimum 1 year of experience - M.Sc or B. Pharm degree Please note that no additional details about the company were provided in the job description.,

You will be responsible for Veeva QualityDocs Implementation and development with the following key responsibilities: - Must be a Senior Veeva QDoc techno/functional developer with the ability to configure the system - Should have a good understanding of Pharma and legal requirements with broad knowledge - Familiarity with Python is preferred for the role - Should be well-versed in validation, qualification, GxP, and Compliance in a regulated environment - Experience with tools like Jira, qTest, and Vera - Familiarity with SAFe agile methodology No additional details about the company were provided in the job description.,

As a Senior Technical Lead Associate Architect specializing in Microsoft Fabric, your role will involve the following key responsibilities: - **Architect & Design Solutions**: Lead the end-to-end architecture of data platforms using Microsoft Fabric, ensuring alignment with business goals and technical standards. - **Data Engineering Leadership**: Guide the data engineering team in building robust, scalable, and efficient data pipelines and semantic models. - **Migration Strategy**: Define and implement validation rules, reconciliation mechanisms, and ensure zero data loss during migration from legacy systems to Fabric. - **Reporting & Visualization**: Architect and optimize reporting layers...

As a Graduate Supplier Engineer in the Purchasing department, you will play a crucial role in ensuring the quality and technical standards of purchased components. Your responsibilities will include: - Developing a supplier risk mitigation plan to handle potential issues proactively. - Managing suppliers to achieve PPAP on-time in collaboration with program buyers and the program Supplier Program Manager. - Monitoring APQP deliverables such as Feasibility commitment, APQP planning, Measurement plans, Control plans, product & process FMEA, validation plans, acceptance reports, appearance approval reports, checking fixtures concepts, checking fixtures R&R studies. - Analyzing first off-tool pa...

Role Overview: You will be joining Polar Racking Inc. as a highly experienced SAT Controller Program Manager. Your main responsibility will be to provide support to the Engineering team by defining program scope, objectives, and deliverables, managing subcontractors, overseeing technical aspects, testing and validation, certification management, risk and issue management, stakeholder communication, documentation and reporting, budget management, and continuous improvement. Key Responsibilities: - Program Planning and Execution: Collaborate with the VP of Engineering and stakeholders to define program scope, objectives, and deliverables. Develop and maintain a detailed program plan, including...

As a Statistician at our company, you will play a crucial role in designing and implementing statistical methodologies for experiment design, model calibration, and validation of process-based models. Your responsibilities will include: - Applying frequentist and Bayesian approaches to uncertainty quantification and predictive modeling. - Working with process-based models such as DayCent and DNDC to ensure robust statistical validation of outputs. - Conducting spatial modeling and geostatistical analyses for large-scale agricultural datasets. - Developing and implementing statistical techniques to support Monitoring, Reporting, and Verification (MRV) frameworks for carbon projects. - Ensurin...

Join us as an Avaloq Developer. This is an opportunity for you, a technically minded individual, to join us as a Software Engineer. You will be designing, producing, testing, and implementing working software, working across the lifecycle of the system. Hone your existing software engineering skills and advance your career in this critical role. This role is being offered at the vice president level. **Role Overview:** Working in a permanent feature team, you will be developing knowledge of aspects of the associated platform across the disciplines of business, applications, data, and infrastructure. You will also be liaising with principal engineers, architects in the domain, and other key s...

Role: Firmware Engineer/Lead - Baremetal & RTOS (Pre-Silicon FPGA/Emulation) Experience: 3-8 years Location: Bangalore Required Qualifications: 3-8 years of experience in bare-metal firmware, driver development & validation on pre-silicon FPGA/emulation platforms (HAPS, Synopsys ZeBu, or equivalent). Strong knowledge of ARM architectures, SoC boot flows, and low-level initialization. Hands-on experience with RTOS bring-up and driver development (FreeRTOS, Zephyr). Hands-on experience with bootloader development/bring-up from QSPI. Strong experience with low-speed IO firmware development (SPI, QSPI, I2C, UART). Strong proficiency in C programming and debugging tools such as JTAG. Strong probl...

Responsibilities : Be responsible for delivering sections of complex engagements for large, medium, and small-sized companies across the globe in the Banking/Financial Services sector. Be competent enough to engage with senior client leadership and business stakeholders. Independently lead business conversations, build business requirements, lead design thinking workshops and solution design. Contribute to account mining and relationship activities with value scan, health check diagnostics, benchmarking, opportunity assessment and presentation to clients. Provide strategic counsel to clients on industry trends, leveraging technological innovations to shape their vision and navigate complex s...

Job Summary Experienced Quality Assurance professional with a strong background in the Active Pharmaceutical Ingredient (API) industry. Responsible for implementing and maintaining GMP-compliant Quality Management Systems to ensure product quality, regulatory compliance, and operational excellence. Key responsibilities include managing documentation, handling audits (regulatory and customer), overseeing batch release, deviation investigations, and ensuring adherence to global regulatory standards (cGMP, ICH, FDA, etc.). The role demands expertise in validation, change control, and continuous quality improvement within a highly regulated API manufacturing environment. Quality Planning and Sch...

As a Shift In charge in the Fill and Finish department, you will play a crucial role in supervising Injectable production and ensuring Qualification and Validation processes are carried out effectively. Your responsibilities will include: - Overseeing the production of Injectable products to ensure they meet quality standards - Supervising a team to ensure smooth operations and timely delivery of products - Conducting Qualification and Validation processes to ensure compliance with regulatory standards - Identifying and implementing process improvements to enhance efficiency and productivity To be successful in this role, you should have a B. Pharm/M. Pharm degree with 3 to 10 years of exper...

As a DT Support at NTT DATA in Noida, Uttar Pradesh (IN-UP), India, your role will involve: - Working as level 1/2 support and being an escalation point for technical and product issues resolution within the team - Monitoring the production environment proactively to prevent performance issues or application crashes - Resolving support issues using your technical expertise and being flexible to explore out-of-the-box solutions - Handling ITIL Methodologies such as Change, Incident, Problem, and Service Management - Monitoring batch processes to ensure timely report generation and transfer to clients as per defined SLAs - Managing recurrent incidents, performing problem management, and escala...