29 Gxp Compliance Jobs

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...

Role Overview The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements. Roles & Responsibilities Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with g...

You should have a minimum of 10 - 12 years of experience in handling complex large transformation projects. Your expertise should include Client Relationship Management with key client stakeholders, understanding their requirements, and the ability to meet them through outsourcing. You should also have experience leading large teams located across multiple cities in India and around the world. Additionally, you should have a proven track record of 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...

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, and assisting in ad hoc adminis...

As the Site QA Head at Sun Pharmaceutical Industries Ltd in Halol, your main responsibility will be to oversee and manage the quality assurance activities at the site. This includes tasks such as documentation review, SOP updates, in-process quality assurance, batch release, internal audits, compliance monitoring, and continuous improvement of quality systems, among others. You will be reporting to the Site Quality Head and will work within the Quality department. Your key responsibilities will involve defining the operational strategy and roadmap for quality assurance management at the site, setting quality assurance goals in line with compliance and regulatory requirements, managing resour...

Key Deliverables: Lead global ELN and lab data platform strategy Implement Biovia Holistic Lab and instrument integration Enable unified lab data for AI/analytics use Build and manage cross-functional digital lab team Role Responsibilities: Align ELN strategy with business goals Ensure GxP and regulatory compliance Guide agile teams on lab system delivery Collaborate with global IT and lab stakeholders

Key Deliverables: Lead digital infrastructure and compliance for over 2000 GxP Lab Instrument Controllers globally Drive end-to-end lifecycle management including qualification, patching, and vulnerability remediation Introduce modern lab technologies and tools aligned with Amgen's digital transformation roadmap Manage and coach cross-functional IS teams including software developers, validation engineers, and scrum masters Role Responsibilities: Define and execute technology strategy for Lab IT aligned with regulatory and business requirements Collaborate with global partners to enhance lab operations and improve scientific data systems Ensure system reliability, compliance, and secure oper...

Key Deliverables: Design, develop, and deploy GxP-compliant applications using Java and Salesforce Collaborate with product teams and architects to define and implement technical solutions Support integrated case management systems and resolve data transfer issues Facilitate user story breakdown and backlog management for agile sprints Role Responsibilities: Drive hands-on implementation and resolution of system performance bottlenecks Align business needs with functional solutions through effective analysis and documentation Mentor junior developers and review deliverables for quality and consistency Ensure adherence to regulatory and agile project management practices

Key Deliverables: Lead enterprise-wide Veeva Vault platform strategy and issue resolution Design scalable, compliant platform architecture with integrated data governance Drive cross-functional collaboration for configuration, integration, and continuous platform improvement Ensure Veeva DevOps standards and team performance across global operations Role Responsibilities: Manage support delivery and enhancement of Veeva Vault and its integrations Oversee team performance, stakeholder alignment, and GxP compliance Maintain platform documentation, standards, and impact assessments Provide strategic leadership on upgrades, innovations, and roadmap execution

Key Deliverables: Lead end-to-end software lifecycle and strategy for Quality tech platforms Ensure global compliance with GxP, Privacy, and regulatory technology standards Build and scale high-performing tech teams for validated system delivery Oversee stakeholder alignment, roadmaps, and cross-functional IS service execution Role Responsibilities: Drive technology vision and team development for Quality IT systems Collaborate globally across product owners, delivery leads, and compliance units Monitor product performance, governance metrics, and improvement loops Ensure budgetary discipline and alignment with Pharma business strategy

Key Deliverables: Lead validation strategy and execution for GxP-compliant IT systems Manage test protocols (IQ, OQ, PQ) and validation documentation lifecycle Ensure alignment with 21 CFR Part 11 and global quality compliance standards Collaborate on test automation, defect resolution, and system improvements Role Responsibilities: Interface with product owners and architects to define validation scope Track and resolve system defects across test cycles with cross-functional teams Provide system support and training to end users across platforms Maintain dashboards and reports to monitor test and validation outcomes

Key Deliverables: Create and execute IQ, OQ protocols ensuring GxP compliance Conduct manual and automated testing for functional and performance assurance Maintain validation documentation aligned with regulatory standards Collaborate on continuous improvement and automation initiatives Role Responsibilities: Validate integrated case management systems per SDLC and regulatory needs Report and manage defects with development and quality teams Identify tools to improve test automation and validation workflows Ensure traceability and compliance through structured change control

You will design & implement various innovative solutions in the realms of Clinical data management, analytics Work in clinical data management and analytics area as part of strategy building, assessment and technology implementation project as business and data analyst Lead and participate in clinical business process discussions with clients, identify requirements and user stories Conduct online interviews and workshops to gather requirements to support the business needs of users Author high-level user stories and develop related tasks, acceptance criteria and review test cases Participate in clinical business process discussions with clients, identify requirements and user stories Work cl...

Senior Data Engineering Manager Regulatory / IPT We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory int...

Senior Data Engineering Manager Regulatory / IPT We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory int...

Senior Manager IT Quality Assurance Location: Hyderabad, India (Amgen India AIN) Work Type: On-site as per site policy Role Overview: This vital leadership role involves executing complex and novel IT QA assignments requiring strategic planning and innovative techniques. You will oversee GxP system reviews and risk assessments per Amgen's quality policies and regulatory standards. As Senior Manager, you will supervise and mentor staff across multiple IT QA workflows, with a focus on compliance, continuous improvement, and cross-functional collaboration. Focus Areas: Computer System Validation (CSV): In-depth knowledge of 21 CFR Part 11, EU Annex 11, and GAMP standards. Audit Trail and Period...

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product managers to ensure detailed and quality technical delivery in an Agile environment. You will maintain efficient development workflows, ensure robust testing practices, and uphold compliance with GxP and regulatory standards . Key Responsibilities Develop detailed test plans and strategies based on project requirements Perform manual and automated testing , including functional, regression, and performance testing Documen...