12 Gxp Systems Jobs

Main Job Tasks Yearly System Management Activities. Monitoring the day-to-day usage, operation, and maintenance of the SSS IT system. Validation of IT systems and application service. Ensure that the computer system is in compliance with internal and external regulatory bodies requirements. Prepare user requirement specifications for system. Manage incidents & Problems. Handle Change Management (Change Request/Deviation) Maintain servers and support server patch management activities as necessary. Deployment of New Site Servers. De-commissioning of old Site Servers. Monitor the effectiveness of the incident and problem management process, make recommendations for improvements Maintaining sta...

Role Overview: Join Amgen in their mission to serve patients by contributing as a Specialist Software Engineer in the Safety ART team, specifically focusing on Safety Reporting. Your technical expertise will be utilized to design, implement, and maintain technological solutions that support pharmacovigilance reporting and analytics, bridging the gap between safety operations and information systems to ensure data integrity, regulatory adherence, and efficient reporting through advanced systems and tools. Key Responsibilities: - Maintain pharmacovigilance systems and provide production support as a System Owner. - Support ETL (Extract, Transform, Load) pipelines for transferring PV/safety dat...

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you are 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 collaborat...

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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 collaborative, in...

As a Veeva System Administrator, your role will involve providing support in system administration and production support (L1/L2/L3) for Veeva Vault Applications as per the company-defined SLA. You should be experienced and certified in Veeva vault, preferably Veeva Vault Quality. Your responsibilities will include troubleshooting and providing support for Veeva Vault applications. Additionally, you are expected to have a good understanding of ServiceNow processes (Incidents, Problem Tickets, Change Managements, Service Requests), Life Science industry processes, GxP systems and documentations. You should also be familiar with user account creation/ modification/ deactivation processes, cust...

We are looking for an experienced Tulip Support Analyst to provide application support for the Tulip MES platform in pharma/life sciences, ensuring GxP compliance, troubleshooting issues, performing configurations, and process improvements.

SystemsPlus is hiring for : R&D IT Business Data Analyst : Life Science Exp : 7 yr + Location : Pune - Magarpatta. Hybrid. Position Summary: We are seeking a highly motivated and detail-oriented R&D IT Business Data Analyst to serve as a critical liaison between IT, R&D, and cross-functional teams in the Biotech Industry. This role supports the integration and optimization of scientific data systems, ensures robust data governance, and contributes to the digital transformation of biotech R&D operations. The ideal candidate has strong analytical skills, understands the complexities of biotech data, and can translate scientific and business needs into actionable IT solutions. Key Responsibilit...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Lead in the evaluation, implementation, and validation of packaged systems. Create, maintain, and oversee processes for providing end user support in EDC systems. Build studies and support other users to build studies in EDC and other GxP systems. Works as par...

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of e...

Be the First to Apply Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview The Deputy Manager - Business Application acts as the liaison between PCC system users, Software support vendors and internal PCC IT support teams. The ideal candidate will be a technical contributor and advisor to the PCC business users to proactively assist in defining strategic application development and integration to support business processes. Key Stakeholders: Internal Sales, Supply Chain, Finance, IT Infrastructure, Info Sec, Corporate IT teams Key Stakeholders: External Vendors, Consultants, Product companies Reporting Structure Reports t...

Roles Responsibilities: Develop and maintain design development activities and deploy applications to support GxP system Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Collaborate with cross-functional teams including product management, development, QA, and business analysts to gather and align stakeholder requirements Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Provide hands-on technical guidance to development teams across the software development lifecycle (SDLC) Maintain knowledge of trends in applic...

The Business Analyst position at Piramal Critical Care (PCC) within the IT department in Kurla, Mumbai involves acting as a liaison between PCC system users, software support vendors, and internal IT support teams. The ideal candidate is expected to be a technical contributor and advisor to PCC business users, assisting in defining strategic application development and integration to support business processes effectively. Key stakeholders for this role include internal teams such as Supply Chain, Finance, Infrastructure, PPL Corporate, and Quality, as well as external stakeholders like the MS Support team, 3PLs, and Consultants. The Business Analyst will report to the Chief Manager- IT Busi...