45 Gxp Compliance Jobs

Minimum 12 - 15 years of experience in handling complex large transformation projects Experience in Client Relationship Management key client stakeholders, understanding their requirements and the Outsourcer's ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise, Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders...

As an experienced candidate, you should have a minimum of 12 - 15 years of experience in handling complex large transformation projects. Your role will involve Client Relationship Management with key client stakeholders, understanding their requirements, and ensuring the Outsourcer's ability to meet them. It is essential to have experience in leading large teams located across multiple cities in India and around the world. Your expertise should also include driving Digital Transformation across a portfolio of accounts and demonstrating a breadth and depth of operational service delivery management. Preferred qualifications for this position include the ability to create technical designs bas...

As a GxP Compliance Consultant/Auditor at SAP, you will be a key player in shaping the future of compliance and security in the cloud ERP landscape. Your role will involve ensuring the organization's compliance with industry regulations and standards, particularly in the realm of SAP Cloud ERP solutions. You will have the opportunity to work on innovative projects, driving compliance excellence, and contributing to the advancement of security and compliance frameworks. **Key Responsibilities:** - Utilize extensive knowledge and experience in ISO/SOC standards to ensure compliance with industry regulations - Work collaboratively with teams to drive compliance excellence and contribute to secu...

As a member of the Security and Compliance team at SAP, you will play a crucial role in assessing regional and industry-specific security compliance regulations, performing gap analyses, creating implementation roadmaps, and implementing standards across teams. You will focus on implementing GxP compliance and upcoming security obligations in SAP Cloud ERP solutions, interacting with various teams within SAP, and leading audit programs. Key Responsibilities: - Assess regional and industry-specific security compliance regulations - Perform gap analyses and create implementation roadmaps - Implement GxP compliance and upcoming security obligations in SAP Cloud ERP solutions - Interact with SAP...

Company Description Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide. Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health. With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients business transformation challenges and set new industry standards through innovative solutions. Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake. Grounded in our commitment to fast and intelligen...

It's more than a job When you work in Freight Logistics and Operations at Kuehne+Nagel, you play a key role in optimising processes and ensuring that inventory and shipments move efficiently. But that is not all. Your work also helps ensure that vital medicines reach patients on time and supports other essential deliveries, from wind turbines to semiconductors. At Kuehne+Nagel, our contribution counts in more ways than we imagine. ? As the Excellence Manager Finance, you will oversee and manage all aspects of KNIL's freight settlement services. This role requires deep knowledge of freight payments, financial processes, and technology solutions. You will work closely with internal teams, cust...

As the Head of Infrastructure you will lead and manage all aspects of IT infrastructure across corporate offices, manufacturing plants, R&D, and distribution sites, ensuring high availability, compliance (21 CFR Part 11, GxP), cybersecurity, and scalability aligned with pharmaceutical regulatory needs. This encompasses data center management, network and server services, telephony systems, service monitoring, user support/help desk, workstation management, backup and recovery solutions, servers, storage, and all related software. You will be operationally accountable for ensuring the continuous availability, integrity, and security of all IT systems and infrastructure that underpin our criti...

Configure and maintain Safety and Medical information database. Manage user accounts, roles, and access controls. Perform routine system checks and maintenance tasks. Provide support during system implementation and post-go-live phases. Act as first-level support for database-related issues via the internal helpdesk tool. Troubleshoot and resolve technical issues in collaboration with IT and vendor teams. Assist in the creation and execution of validation documentation (URS, FRS, IQ/OQ/PQ). Ensure systems comply with GxP, 21 CFR Part 11, and other relevant regulations. Develop and update training materials for end-users. Conduct training sessions and onboarding for new users. Support interna...

You are a seasoned Ignition SME/Solution Architect with over 4 years of hands-on experience in Ignition by Inductive Automation and 10+ years in IT/OT systems integration. Your role will involve architecting and deploying scalable Industrial IoT (IIoT) solutions across manufacturing environments, focusing on going beyond traditional SCADA implementations. Your deep expertise in OT systems, MQTT protocol, UNS design, and ISA-95 contextualization, along with a proven track record of template-driven, reusable solution delivery across multiple sites, will be crucial for success. - Lead the architecture, design, and deployment of IIoT solutions using Ignition Perspective, MQTT, and edge computing...

You will be joining Hitachi Digital Services, a global digital solutions and transformation business focused on unlocking potential through expertise, innovation, and technology. As a Solution Design Expert, you will play a key role in infrastructure design with a focus on data center and Public Cloud Infrastructure Deployment & Design. Your responsibilities will include: - Creating and leading solution designs for internal customers, ensuring they meet business needs - Developing project rationale and scoping assessments to determine project feasibility - Designing and deploying new solutions and services while considering the overall user experience - Ensuring implemented solutions adhere ...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Role & responsibilities 1. To attend/supervise all jobs related to Engineering (Mechanical maintenance) and projects at site. 2. Preparation and Review of all documents related to Engineering Maintenance. 3. Execution of maintenance jobs of all utility equipment as per SOP and Good engineering practice. 4. To maintain critical spares related to mechanical for all equipment in site. 5. To attend emergency breakdown on all plant wide machines round the clock as and when the need arises. 6. Timely execution of all preventive maintenance jobs in co-ordination with vendor and users. 7. To maintain the preventive maintenance logs, area/ equipment log and preventive maintenance schedules for all th...

Job Description Tulip Developer Position: Tulip Developer Location: Indore, India Experience Required: 5+ years overall, with 23 years in Tulip development within a GxP-regulated environment Role Overview We are seeking a skilled Tulip Developer to join our team and support the design, development, and deployment of applications on the Tulip platform within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will have a strong background in application development, digital manufacturing, and process automation, with hands-on experience delivering solutions that meet compliance and operational excellence standards. Key Responsibilities Design, develop, configure, and...

You will be providing quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Your main responsibilities will include: - Performing and delivering Quality Operations services to support product quality compliance and regulatory workflows. - Holding accounts in workflow applications to ensure proper execution of service deliverables. - Generating and analyzing predefined and ad-hoc reports in various applications. - Escalating service-related issues for timely investigation and compliance. - Ensuring compliance with internal quality standards and relevant regulatory requirements. - Assisting in ad ho...

As the Site QA Head at Halol, your primary responsibility will be to manage the overall quality assurance oversight and site activities related to quality systems. This includes documentation review, SOP updates, in-process quality assurance, sampling and batch release, preventive maintenance, calibration, qualification, validation, internal audits, compliance, quality oversight of electronic systems, budget management, continuous improvement of quality systems, RA support, monitoring of pest control, and retention sample management as per Good Manufacturing Practices requirements. Your key responsibilities will include: - Defining operational strategy and roadmap for quality assurance manag...

Working with Us Challenging. Meaningful. Life-changing. Those aren&apost words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You&aposll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We o...

As the Site QA Head at Sun Pharmaceutical Industries Ltd, your role will involve managing overall quality assurance oversight and site activities related to quality systems. This includes documentation review, SOP updates, in-process quality assurance, sampling and batch release, preventive maintenance, calibration, qualification, validation, internal audits, compliance, quality oversight of electronic systems, budget management, continuous improvement of quality systems, RA support, monitoring of pest control, and retention sample management as per Good Manufacturing Practices requirements. Your key responsibilities will include: - Defining operational strategy and road map for quality assu...

You should have a minimum of 10-12 years of experience in handling complex large transformation projects. Your role will involve managing key client stakeholders, understanding their requirements, and ensuring that outsourcing abilities meet their needs. Additionally, leading large teams located across multiple cities in India and around the world will be a key responsibility. Moreover, you should have experience in driving digital transformation across a portfolio of accounts while demonstrating a breadth and depth of operational service delivery management expertise. Preferred qualifications include the ability to create technical designs based on functional designs, which may involve crea...

You should have at least 7+ years of experience in SAP, with a specific focus on master data migration. It is essential that you have at least 5 years of experience working with SAP, particularly in master data conversion. Experience within the LS industry is a must, as well as a proven track record of migrating data from JDE/Oracle to SAP. You will be responsible for providing legacy to source mapping and defining rules for extraction of master and transaction data while collaborating with the business. Your role will require you to work in a validated environment with GxP compliance, so experience in this area is necessary. An understanding of testing and data verification processes during...

Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Establish trusted partnership with assigned IT Function with unders...

JD: GxP Manual Functional Tester: • Minimum 6+ years of experience in manual testing in GxP-compliant environments • Good understanding of STLC, Functional testing, FIT, UAT, Defect Management • Hands on experience in FIT Test case design and executions • Hands on experience in UAT test design • Working experience with Agile Incremental testing • Experience with test management tools (Jira) • Understanding of SDLC and Agile methodologies • Good communication and documentation skills • Collaborate with business, development, and regulatory teams • Track and report defects using Jira or similar tools

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a CSV , Compliance Gxp to join our team in Bangalore, Karn?taka (IN-KA), India (IN). Job Description . Skill Area: CSV, Compliance Gxp, Infrastructure support . Main Technology: Compliance . Mandatory Skills: (Must Have Skills) - GxP, Compliance , CSV knowledge, Qualification and Maintenance . Optional Skills: (Good to Have Skills) - Tools exp - TIMS, ADO, Servicenow . Roles & Responsibilities: QC key Responsiilites : Support IT Infrastructure qualification activities e.g...

Are you ready to help shape the future of healthcare Join GSK, a global biopharma company with a special purpose to unite science, technology, and talent to get ahead of disease together. GSK aims to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. As an organization where people can thrive, GSK is committed to preventing and treating diseases on a global scale. By joining GSK at this exciting moment, you can contribute to the mission of getting Ahead Together. As the Principal Data Engineer at GSK, you will play a crucial role in transforming the commercial manufacturing and supply chain organization. Your responsibilities will i...

As an experienced and dynamic Validation Lead/Manager with 8-12 years of experience, you will be responsible for overseeing validation activities to ensure compliance with Good Practice (GxP) standards, including GLP, GCP, and GMP. Your role will involve managing validation teams, driving the validation strategy for key projects, and ensuring regulatory compliance. Your key responsibilities will include leading the validation team in maintaining GxP compliance, developing and implementing validation strategies, supervising and mentoring validation engineers/specialists, overseeing the development and approval of Computer System Validation (CSV) documentation, leveraging product knowledge in ...

Roles & Responsibilities: Collaborate with business and data stakeholders to gather requirements, assess data needs, and ensure data quality, privacy, and compliance across ETL pipelines. Lead day to day operations and configiuring of Amgen s R&D Veeva Vault Platform and hosted applications. Possesses strong rapid prototyping skills and can quickly translate concepts into working code. Lead day to day operations and maintenance of Amgen s Veeva Vault eTMF and hosted applications. Stay updated with the latest trends, advancements and standard process for Veeva Vault Platform ecosystem. Design, develop, and implement applications and modules, including custom reports, SDKs, interfaces, and enh...