30 Gxp Regulations Jobs

Work Schedule Standard (Mon-Fri) Environmental Conditions Office As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Job Title: Lead AMS & IT Operations Support Location: India IT Center ...

Role Overview: At Lilly, we are looking for a Digital CMC Configuration Engineer to join the Product Lifecycle Management (PLM) program team. As a key member, you will be responsible for configuring manufacturing data within the digital PLM platform, supporting deployments, and ensuring continuous improvement. Key Responsibilities: - Collaborate with cross-functional teams to implement digital product control strategies in the PLM system. - Assist in designing and executing data transfer protocols while adhering to CMC standards and regulatory requirements. - Support configuration, maintenance, and governance of digital PLM systems. - Analyze and resolve routine data discrepancies during pro...

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. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such...

Role Overview: HELM Pharmaceuticals GmbH, a B2B pharmaceutical company based in Hamburg, Germany, is seeking an experienced Operations Support Manager (m/f/d) for their offices in India. As the Operations Support Manager, you will be responsible for cross-functional collaboration, quality assurance, and commercial support in the pharmaceutical industry. Key Responsibilities: - Collaborate cross-functionally with Operations Management, Procurement, and Quality Unit to maintain operational business with Asian API suppliers and CMOs. - Assist the global Quality Team in inspections, audits, and GMP/GDP audits at suppliers primarily in India and Asia. - Work with the Quality Unit and Operations t...

As an Information Management and Governance Business Analyst at our company, you will be a key player in our data transformation journey, focusing on unstructured content and preparing it for AI usage through effective classification, metadata processes, and governance. Your responsibilities will include: - Planning and conducting workshops and interviews to gather requirements from business, technical, and data governance stakeholders. - Eliciting, documenting, and prioritizing requirements for identifying, curating, and enriching critical information using methodologies like MoSCoW or RICE. - Developing epics, user stories, and acceptance criteria. To excel in this role, you should possess...

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborati...

As a Software Engineer in the Industrial IoT team, you will play a crucial role in developing, implementing, and maintaining the IoT platform that is key to modernizing industrial systems. Your collaboration with a global team of engineers, automation specialists, IT professionals, and operations teams will ensure the delivery of robust, scalable, and compliant IoT solutions. Your contribution will drive the transformation of the industrial network by leveraging modern technologies and integrating IoT with enterprise systems. **Key Responsibilities:** - Contribute to the design, software development, deployment, and maintenance of the industrial IoT platform. - Develop new features for the I...

Role Overview: As a Digital Risk & Compliance Expert Controls Assurance at Sanofi, your role will involve driving the execution of assessment and testing campaigns such as GxP Periodic Reviews and Third Party Assessments. You will be part of the Digital Risk & Compliance team, working towards demonstrating risk & compliance health across critical digital solutions to protect patient safety and contribute to Sanofi's growth. Your impact will extend beyond the team as you support the Digital transformation efforts with a focus on accelerating the time from discovery to therapy. This role offers the opportunity to work in an international environment, collaborate with diverse business teams and...

Role Overview: At Takeda, we are at the forefront of digital evolution and global transformation, building innovative solutions and future-ready capabilities to meet the needs of patients, employees, and the planet. As a Risk and Compliance Analyst at Takeda's Innovation Capability Center in Bengaluru, you will play a crucial role in overseeing computer systems validation programs within a regulated cGMP environment. Your contributions will be instrumental in ensuring compliance with industry standards, implementing risk-based validation strategies, and delivering high-quality, compliant solutions to support Takeda's mission. Key Responsibilities: - Plan, draft, and maintain validation docum...

Role Overview: You will be the Sr Manufacturing Systems Engineer specializing in Manufacturing Execution Systems (MES) at Amgen India (AIN). As a technical leader, you will be responsible for overseeing the lifecycle upgrades, maintenance, and optimization of MES systems across Amgen's global manufacturing network. Your role will be crucial in ensuring reliable data collection, integration, and analytics for manufacturing operations, thereby driving digital transformation and operational excellence within the company. Key Responsibilities: - Lead the lifecycle upgrades, migrations, and enhancements of MES systems at various Amgen manufacturing sites. - Act as a technical subject matter exper...

Use Your Power for Purpose As a Manager Corporate Audit at Pfizer, you will play a crucial role in ensuring the integrity and reliability of our digital systems, directly impacting our ability to improve patients lives. You will contribute to the safeguarding of our financial and operational data, enabling us to continue our mission of delivering breakthroughs that change patients lives. What You Will Achieve Conduct independent evaluations of Pfizer's Information Systems and compliance control processes worldwide to ensure Pfizer's risks are properly managed. In this role, you will Lead and execute IT audits, including planning, fieldwork, and reporting. Assess the effectiveness of IT contr...

Role Description: In this vital role, you will be part of the Quality Control (QC) Products Team , collaborating closely with business partners, product owners, analysts, developers, and testers to ensure that validation activities and strategies for IT systems are executed effectively and in compliance with organizational and regulatory requirements. This position plays a key role in driving compliance, efficiency, and innovation in the management of data validation processes that support the QC product lifecycle. You will help advance continuous improvement and automation initiatives across the QC digital ecosystem, ensuring systems and tools are optimized to meet evolving quality standard...

In this vital role, you will be part of the Quality Control (QC) Products Team, collaborating closely with business partners, product owners, analysts, developers, and testers to ensure that validation activities and strategies for IT systems are executed effectively and in compliance with organizational and regulatory requirements. This position plays a key role in driving compliance, efficiency, and innovation in the management of data validation processes that support the QC product lifecycle. You will help advance continuous improvement and automation initiatives across the QC digital ecosystem, ensuring systems and tools are optimized to meet evolving quality standards. - Act as a liais...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

Hi, We are having an opening for IT Service Assurance Manager at our Mumbai location. Job Summary : We are seeking a seasoned and proactive IT Service Assurance Manager to oversee and optimize the delivery of IT services in a highly regulated pharmaceutical environment. This role is pivotal in ensuring IT services align with business needs, comply with GxP (Good Practice) regulations, and support the organizations mission to deliver high-quality healthcare solutions. The ideal candidate will have a strong background in IT service management, preferred experience in the pharmaceutical or life sciences sector. Areas Of Responsibility : Overseeing global IT service delivery across all Sun Pharm...

Summary The Quality Lead Data & Digital TRD QA is responsible for overseeing, driving and implementing global data & digital (DDI) projects and initiatives within Technical Research and Development (TRD) Quality Assurance (QA). This role collaborates closely with relevant partners in TRD, Research & Development Quality (RDQ) and Operations Quality and leads the TRD QA DDI Network. The role incumbent ensures all DDI projects and related business processes are well supported by TRD QA and covered by change control as applicable. The role owner also drives digitalization and artificial intelligence (AI) solutions within TRD QA and is the Go to person for related topics within this organization....

As the Quality Lead Data & Digital TRD QA at Novartis, you will be responsible for overseeing, driving, and implementing global data & digital projects within Technical Research and Development Quality Assurance. Your role will involve collaborating closely with relevant partners in TRD, Research & Development Quality, and Operations Quality, leading the TRD QA DDI Network, and ensuring all DDI projects and business processes are well supported and covered by change control. **Key Responsibilities:** - Lead the global TRD QA DDI Network with a team of direct and/or indirect reports - Ensure DDI projects impacting TRD are well supported and covered by change control - Drive the TRD QA DDI age...

As a Quality Systems Lead at BioBioPharma Tech Solutions, you will be responsible for managing Veeva Vault Workstreams on a global level. Your role will involve providing project management leadership for Veeva QMS Workstreams, creating reports, monitoring system compliance, owning governing procedures, and supporting validation and configuration activities. You will also be responsible for providing guidance and support for site requests, issue resolution, and regulatory inspection requests. Key Responsibilities: - Provide project management leadership for Veeva QMS Workstreams including Quality Docs, Vault Training, QMS, Validation, etc - Create reports, monitor and maintain system complia...

The Digital Risk & Compliance Expert Controls Assurance will be responsible for driving the execution of assessment and testing campaigns such as GxP Periodic Reviews & Third Party Assessments within the Digital Risk & Compliance team. Your impact will extend beyond the team as you support the Digital transformation objective of halving the time from discovery to therapy by ensuring Risk & Compliance at the speed of the business. In this role, you will have the opportunity to work in an international environment as part of a dynamic team, empowered to propose and implement innovative ideas. You will collaborate with diverse business teams and vendors, gaining hands-on experience and contribu...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

The MES Lifecycle Manager role at Sanofi is integral to the company's digital transformation and standardization efforts within Manufacturing & Supply. You will be responsible for overseeing the lifecycle management of MES systems, including MARS implementations across multiple production sites globally. Your main focus will be on strategic planning and execution of MES installations, updates, and migrations to optimize performance, reduce obsolescence, and align capabilities with digital transformation goals. Your key responsibilities will include developing and executing a comprehensive MES lifecycle planning strategy, orchestrating high-level planning of MES initiatives across industrial ...