231 Gxp Jobs - Page 8

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an e...

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an e...

Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise , validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validatio...

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, de...

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing 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 an...

We are looking for Automation Test Engineer - GXP Validation professionals for our IT services division. who is having experience in below technical stack. Please revert if you are interested with below requested information. Required Skills: Selenium with Java, Automation, Rest Assured, API testing, Bdd frameworks, GXP, / Good x Practice. Qualification: UG / PG Graduates Experience: 5-10 Years Location: Chennai / Coimbatore / Bengalore / Pune Work Time: 2pm to 11pm Work Mode: Hybrid Model (3 Days work from office) Notice Preferred: 0-30 Days. Preferred Project experience: Healthcare, Life science. Responsibilities: Develop and maintain automated test scripts and frameworks. Perform function...

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and doc...

We are looking for a strategic and seasoned Manager / Sr. GM - Human Resources to lead and elevate our Human Resources function at Chieron Active Ingredients Pvt Ltd. This critical leadership role will oversee the entire HR department across multiple locations, ensuring the effective implementation of HR policies, fostering a positive and productive company culture, and driving strategic HR initiatives aligned with business objectives. The ideal candidate will possess deep expertise in stakeholder management, industrial relations, contract workforce management, compliance, audit & governance, talent acquisition & development, HR operations & policy governance, and strategic HR leadership. Th...

Summary Are you a seasoned Automation Engineer with a passion for cutting-edge technology and a desire to revolutionize manufacturing processesIf so, we invite you to join us as an Associate Director ITOT Automation Engineer at Novartis, As an integral member of our team, you will play a critical role in defining and implementing the automation concept for both our new and existing manufacturing facilities Your expertise will be instrumental in ensuring that our automation designs and equipment are aligned with IT/OT standards, while leveraging the latest technologies available, In this pivotal position, you will be involved in a wide range of investments, collaborating with cross-functional...

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the o...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge...

Job Title: IT Manager - Infrastructure, Networking & GxP Systems Location: Sarigam Vapi, Gujarat Department: Information Technology Job Summary: We are seeking an experienced IT Manager to lead the IT infrastructure, networking, and production/QC instrumentation functions within our pharmaceutical manufacturing facility . The ideal candidate will be responsible for ensuring compliance with USFDA, GxP, CFR Part 11, and other regulatory IT requirements , while managing IT operations to support manufacturing and quality control. Key Responsibilities: 1. IT Infrastructure & Networking Management Oversee IT infrastructure , including servers, storage, networking, and data centers . Manage enterpr...

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle ...

About The Role Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. ? Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to...

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality...

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. C...

The Gen AI Team Lead holds a pivotal position within the DigitalX organisation, responsible for multiple value teams under the EnablementX hub. This role involves leading and managing these teams, steering the PODs strategic and tactical goals, and ensuring alignment with the aspirations of the DigitalX leadership. Essential duties include coordinating value teams, developing and implementing roadmaps, coaching team captains, guiding backlog grooming, leading POD management standups and retrospectives, consolidating value team statuses at the POD level, and working closely with the hub leadership team. Responsibilities: Lead and guide teams and team captains, assisting in the planning and ex...

Job title TOSCA automation Tester Job mode : Remote Location : Any were in India Work mode : Long term Contract More than 1 year Note : This is totally Remote in India need to travel once in a Month Near by location to client place Job Description: Strong have analytical and problem-solving skills as well as the ability to decompose complex problems and perform root cause analyses in troubleshooting customer issues in tosca. 8-10 Years of hands-on experience in Tosca Should have knowledge on DEX integration Should have knowledge on day-to-day activity like repo creation, User access management and other operations activity Should have knowledge on Windows server for performing activities lik...

Role & responsibilities PAYROLL ORGANIZATION : VALUE INNOVATION LABS https://valueinnovationlabs.com/ Preferred candidate profile Title: Technical Product Owner Work Location - Bangalore Qualifications: • Bachelors degree in Computer Science, Information Technology, Business Administration, or a related field, or equivalent by experience. Masters degree or relevant certifications are a plus. • 5+ years of experience in product management or product ownership, with at least 3 years focused on Governance Risk and Compliance, enterprise risk management technologies or similar solutions. • Experience shaping integrated risk management dashboard, providing centralized views of risk activities and...

Work profile: Plant IT Operations (Pharma and Biotech) Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 7-10 years (L2) Duration : 1 year contract Role & responsibilities: Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for ent...

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-fun...

MDM Business Performance Manager What you will do Let’s do this. Let’s change the world. In this vital role you will lead the optimization of master data processes across Amgen’s global operations, ensuring data quality, consistency, and governance. They are responsible for driving continuous improvement initiatives, and strategic projects, focusing on improving data accuracy, reducing process inefficiencies, and aligning data management practices with business objectives. This role will collaborate with IT, Supply Chain, and other key stakeholders to ensure that MDM processes support operational needs and regulatory compliance. Roles & Responsibilities: Lead the development and implementati...

Mgr Information Systems What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for leading the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) wit...