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Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus

You are a seasoned verification engineer with a passion for cutting-edge technology With a BSEE in Electrical Engineering and over 5 years of relevant experience, or an MSEE with over 4 years, you bring a wealth of knowledge in developing System Verilog based test environments, implementing test plans, and extracting verification metrics You possess strong HVL coding skills and hands-on experience with industry-standard simulators such as VCS, NC, or MTI, and waveform-based debugging tools Your familiarity with verification methodologies like VMM, OVM, or UVM is solid, and you have a deep understanding of protocols such as AMBA, SD/eMMC, MIPI-I3C/UFS/Unipro, Ethernet, DDR, PCIe, and USB Your experience with Scatter Gather DMA and exposure to serial protocols like SPI/I2C/I2S/UART are highly valued Additionally, you are proficient in scripting languages such as Perl, TCL, or Python, and have knowledge of HDLs like Verilog Your exposure to VC Formal and IP design and verification processes, including VIP development, is an added advantage You exhibit excellent written and oral communication skills, demonstrate strong analytical and problem-solving abilities, and show high levels of initiative This role is not open for college fresh grads and requires prior industry experience What You ll Be Doing: Specify, design/architect, and implement state-of-the-art verification environments for the Synopsys family of synthesizable cores. Perform verification tasks for IP cores, ensuring they meet the highest standards of quality. Collaborate closely with RTL designers and be part of a global team of expert verification engineers. Work on next-generation AMBA protocols and serial protocols for commercial, enterprise, and automotive applications. Engage in test planning, test environment coding at both unit and system levels, test case coding and debugging, and FC coding and analysis. Manage regression and meet quality metric goals. The Impact You Will Have: Ensure the reliability and performance of Synopsys IP cores, contributing to the success of our cutting-edge products. Drive innovations in verification methodologies, enhancing the efficiency and effectiveness of our processes. Collaborate with a global team to deliver high-quality solutions that meet the needs of our customers. Support the development of next-generation technologies that will shape the future of various industries. Contribute to the continuous improvement of verification practices and standards within the organization. Play a key role in the successful delivery of IP cores for commercial, enterprise, and automotive applications. What You ll Need: BSEE in Electrical Engineering with 5+ years of relevant experience or MSEE with 4+ years of relevant experience. Experience in developing System Verilog based test environments and implementing test plans. Strong HVL coding skills and hands-on experience with industry-standard simulators and waveform-based debugging tools. Familiarity with verification methodologies such as VMM, OVM, or UVM. Knowledge of protocols such as AMBA, SD/eMMC, MIPI-I3C/UFS/Unipro, Ethernet, DDR, PCIe, and USB. Who You Are: Excellent written and oral communication skills. Strong analytical and problem-solving abilities. High levels of initiative and the ability to work independently. Collaborative mindset with the ability to work effectively in a global team environment. Detail-oriented with a focus on quality and continuous improvement

What You ll Be Doing: Implementing state-of-the-art Verification environments for the DesignWare family of synthesizable cores. Performing Verification tasks for IP cores, focusing on domains such as USB, PCI Express, Ethernet, and AMBA. Collaborating closely with the RTL design team and other expert Verification Engineers globally. Engaging in Test planning, Test environment coding at both unit and system levels, Test case coding, and debugging. Coding and analyzing functional coverage and meeting quality metric goals. Managing regression processes to ensure comprehensive verification. The Impact You Will Have: Enhancing the robustness and reliability of our IP cores, ensuring high-quality deliverables. Contributing to the development of innovative solutions that drive the Era of Smart Everything. Reducing the time-to-market for our customers by ensuring their products meet performance, power, and size requirements. Supporting the integration of more capabilities into SoCs, enabling differentiated products. Participating in a global team effort to advance cutting-edge technologies in chip design and software security. Ensuring the successful verification of complex IP cores, contributing to the overall success and reputation of Synopsys. What You ll Need: BS/BE in Electrical Engineering with 5+ years of relevant experience or MS with 3+ years of relevant experience in IP core and/or SOC verification. Proficiency in developing HVL-based test environments and implementing test plans. Hands-on experience with industry-standard simulators such as VCS, NC, and MTI, and relevant debugging tools. Strong understanding of verification methodologies like UVM/VMM/OVM. Familiarity with Verilog and scripting languages such as Perl. Basic understanding of functional and code coverage. Excellent written and oral communication skills, along with strong analytical, debugging, and problem-solving abilities. Who You Are: A self-driven individual with a passion for technology and innovation. A collaborative team player with the ability to work effectively in a global team environment. A detail-oriented professional with a commitment to delivering high-quality work. A proactive learner who stays updated with the latest industry trends and technologies.

This is a verification focused individual contributor s role. The candidate will be part of the DesignWare IP Verification R&D team at our Bangalore Design Center, India. Implement state-of-the-art Verification environments for the DesignWare family of synthesizable cores and perform Verification tasks for the IP cores. Work closely with RTL design team and be part of a global team of expert Verification Engineers. Domains will include but not be limited to USB, PCI Express, Ethernet, AMBA. Job role will have a combination of Test planning, Test environment coding both at unit level and system level, Test case coding and debugging, FC coding and analysis and meeting quality metric goals and regression management. Requirements: - BS/BE in EE with 8+ years of relevant experience or MS with 6+ years of relevant experience in the verification of IP cores and/or SOC verification. - Experience in developing HVL based test environments, developing and implementing test plans, implementing and extracting verification metrics such as functional coverage. - HVL coding skills for Verification and be hands-on with one or more Industry standard simulators such as VCS, NC, MTI used in Verification and relevant debugging tools. - Exposure to verification methodologies such as UVM/VMM/OVM is required. - Familiarity with HDLs such as Verilog and scripting languages such as perl is highly desired. - Exposure to IP design and verification processes including VIP development is an added advantage. - Basic understanding of functional & Code coverage. - It is essential that the individual has good written and oral communication skills and is able to demonstrate good analysis, debug and problem solving skills and be self-driven. Our Silicon IP business is all about integrating more capabilities into an SoC faster. We offer the world s broadest portfolio of silicon IP predesigned blocks of logic, memory, interfaces, analog, security, and embedded processors. All to help customers integrate more capabilities. Meet unique performance, power, and size requirements of their target applications. And get differentiated products to market quickly with reduced risk. At Synopsys, we re at the heart of the innovations that change the way we work and play. Self-driving cars. Artificial Intelligence. The cloud. 5G. The Internet of Things. These breakthroughs are ushering in the Era of Smart Everything. And we re powering it all with the world s most advanced technologies for chip design and software security. If you share our passion for innovation, we want to meet you.