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4 System Compliance Jobs

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6.0 - 10.0 years

0 Lacs

kolkata, west bengal

On-site

As an experienced SAP Program Manager, you will be responsible for leading end-to-end SAP operations, driving system implementation, integration, and process optimization to ensure business continuity and efficiency. Your role will require strong leadership skills, deep SAP expertise, and the ability to manage high-priority projects in a fast-paced environment. Your key responsibilities will include leading, managing, and overseeing the entire SAP program lifecycle from planning to execution. You will manage and support SAP Business One (B1) and related SAP modules, drive system upgrades, enhancements, and integrations aligned with business objectives, and collaborate with cross-functional teams to ensure seamless process automation and optimization. Ensuring system compliance, data integrity, and security across all SAP modules, monitoring SAP system performance, providing user training, documentation, and continuous support to internal stakeholders, and aligning SAP capabilities with organizational goals for digital transformation initiatives will be crucial aspects of your role. Additionally, you will coordinate with external vendors, consultants, and implementation partners for project success. To excel in this role, you must possess strong expertise in SAP Business One and relevant SAP ERP modules, proven experience in SAP implementation, integration, and program management, and a solid understanding of business processes in the manufacturing domain. Your project management skills should include experience in Agile/Waterfall methodologies, and you should demonstrate excellent analytical, problem-solving, and decision-making abilities. Proficiency in stakeholder management and cross-functional collaboration, knowledge of data migration, reporting tools, and SAP analytics, a strong understanding of system compliance, IT governance, and security protocols, as well as the ability to work under pressure and manage multiple priorities are also essential for success in this role.,

Posted 1 week ago

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4.0 - 8.0 years

0 Lacs

karnataka

On-site

The job involves following departmental Standard Operating Procedures and Work Instructions, completing required training within specified timelines, and auditing System Life Cycle (SLC) activities and documentation. You will be responsible for planning, conducting, and leading global internal facility, system, and process audits, as well as external audits of vendors and suppliers. Additionally, you will participate in client and regulatory visits as a subject matter expert in computerized systems and technology compliance. You will also be involved in authoring and reviewing controlled documents, advising internal business, IT, and QA partners on systems and technology compliance, and leading process and continuous improvement projects. Ensuring Regulatory Compliance and Quality Assurance (RC and QA) responsibilities are followed as per controlled documents is essential. Other duties may be assigned by management. Minimum Qualifications required for this role include a bachelor's degree in Life Sciences or equivalent experience in Life Sciences. Relevant and equivalent experience may be considered in lieu of educational requirements. Experience of at least 4 years in a regulatory environment with system compliance experience is necessary. A sound understanding of standard computer system development life cycles is required to provide guidance to both information technology and operational personnel. Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines is essential. Experience in applying regulations in at least one GxP discipline and computerized systems standards to drug development is preferred. Strong analytical, organizational, and interpersonal skills are required along with the ability to confidently interact with clients and regulatory personnel, conduct effective training, and negotiate ideas and suggestions effectively. Preferred Qualifications include a bachelor's degree in Life Sciences or equivalent experience in Life Sciences. The job entails working in 2nd shift hours from 2 PM to 11 PM IST. Tasks involve sitting in front of a terminal for extended periods during the working day. Some overtime and weekend work may be required, and regional travel of up to 5% of the time may be necessary. For further details about Equal Employment Opportunity (EEO) and Accommodations requests, please refer to our website.,

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3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a DevOps Engineer for AI products at Linde, you will play a crucial role in the Artificial Intelligence team within Linde's global corporate division. You will collaborate with a diverse international team consisting of Project Managers, Data Scientists, Data and Software Engineers, and other professionals. Your responsibilities will include designing, implementing, and managing robust CI/CD pipelines to support the deployment of AI and data-driven applications globally. You will be tasked with administering and monitoring cloud-based infrastructure to ensure high availability, security, and cost-efficiency of AI product deployments. Additionally, your role will involve developing and maintaining containerized environments using Docker, orchestrating deployment strategies, and establishing infrastructure monitoring and logging solutions for AI platforms in production. It is essential that all DevOps practices adhere to Linde's security guidelines and industry best practices. To succeed in this role, you should have a Bachelor's degree or equivalent experience in a related field such as Statistics, Mathematics, Computer Science, or Engineering. You must possess a good understanding of modern web applications, cloud platforms (Azure, AWS, GCP), Docker, CI/CD pipelines, and database deployments. Experience with automation tools like Azure DevOps and Github Actions is required, along with strong communication skills in English. Linde is a renowned global industrial gases and engineering company operating in over 100 countries. By joining Linde, you will have the opportunity to work on cutting-edge projects that make the world more productive while contributing to sustainability and environmental protection. If you are looking for a career where your work transcends boundaries and positively impacts the world, Linde offers limitless opportunities for growth and development. If you are inspired to be part of a dynamic team that values innovation and excellence, we encourage you to submit your complete application (motivation letter, CV, certificates) through our online job market. At Linde, we are committed to fostering a diverse and inclusive workplace where individuals of all genders can thrive and succeed. Join us at Linde and unleash your potential to make a meaningful difference in the world.,

Posted 1 month ago

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3.0 - 5.0 years

3 - 6 Lacs

Ahmedabad

Work from Office

Role & responsibilities To review & comment on the draft protocol, draft Informed Consent Documents (English ICD), draft Case Report Form (CRF) and/or associated documents received from (Medical Writer team) as per SOP and applicable regulatory guidelines. To review & comment on draft report including all appendices (Clinic related sections) and final e-CTD report received from Report writer in accordance with related SOP/regulatory guidelines/sponsor requirement. To review the respective documents as per defined timelines and/or as per the priority. To review the respective documents updated based on sponsor comment, regulatory observation and ensure compliance to the same. To responsible to review departmental Sops. To review Sponsor comments and regulatory observations and provide response within stipulated time line. Co-ordinate with team for implementing new sop in the system. Ensure that necessary corrective actions are taken for all the findings/comments/suggestions with appropriate preventive measures. Any other task assigned by reporting authority

Posted 2 months ago

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