418 Gxp Jobs - Page 17

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to dr...

Novo Nordisk Global Business Services (GBS) India Department Commercial DD&IT, GBS Are you passionate about IT validation and compliance? Do you want to play a pivotal role in ensuring regulatory adherence and driving innovation in a global pharmaceutical company? If you have the expertise and enthusiasm to lead in this critical area, we want to hear from you! Read on and apply today. The position As a Lead IT Validation & Compliance at Novo Nordisk, you will be entrusted with the following responsibilities: Ensure IT compliance by monitoring adherence to regulations like GDPR and GxP, aligning systems with evolving standards, and enforcing internal policies. Lead IT system validation by man...

Responsibilities and Duties Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP. Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side. Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5. Coordinate with Client to carry out Validation activity of Computer...

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Require...

BIOVIA OneLab Foundation Developer with expertise in workflow design, method configuration, and instrument integration. Must have hands-on experience with OneLab 2023 SP2, GxP compliance, and lab informatics in regulated environments.

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. ?? Key Responsibilities: Act as SME for assigned applications—supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with sta...

Role & responsibilities Position Summary: We are seeking an experienced Quality Engineer (QE) with a strong understanding of Good Manufacturing Practice (GxP) regulations. The ideal candidate will play a key role in ensuring that our products meet the highest quality standards by supporting manufacturing operations and ensuring compliance with regulatory requirements. The role will require a deep understanding of GxP and the ability to drive continuous improvements in quality systems, processes, and product quality. Key Responsibilities: Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements. Develop, implement, and maintain quality engi...

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Polici...

Job Title: Junior IT Administrator Bioanalytical Lab Support Experience: 2-3 Years Job Summary: The Junior IT Administrator will assist in maintaining the IT infrastructure and systems used in regulated bioanalytical operations within a GLP/GxP-compliant CRO laboratory. This role involves daily user support, troubleshooting, and basic system administration related to lab instruments, LIMS, and networked IT systems. Key Responsibilities: User & System Support Provide first-level IT support for lab users on desktops, applications, and hardware. Troubleshoot issues with instrument PCs, printers, and lab software (e.g., LIMS, Lab Solution, Analyst software). Ensure timely resolution of support t...

Primary Skills: 5+ years of experience in Veeva Vault Clinical (CTMS, eTMF, and/or Study Startup). 5+ years of experience in clinical trial processes and documentation workflows. 5+ years of experience in application support in GxP-regulated environments. 4+ years of experience in Vault Admin Console, security configuration, object lifecycle management. 4+ years of experience in managing support tickets using tools like ServiceNow, Jira, or Remedy. 4+ years of experience with validation (CSV or CSA) and change control procedures. 3+ years of experience managing or mentoring a small team or leading client interactions Role & responsibilities : Lead and manage the application support team for ...

Job Location: Ahmedabad Experience Year : 3-5 Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define a validation strategy based on risk and regulatory impact Documentation: Create and review validation documentation, including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ),...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...

Test Lead - Embedded Software Domain: Medical (must have) Location: Bangalore 5 days WFO white field Skill: Experience in qualification of System(computer systems or Analytical instruments). Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix...

Novo Nordisk Global Business Services (GBS) India DepartmentCentralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Senior Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. The Position As a Senior Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical...

Novo Nordisk Global Business Services (GBS) India Department: Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. The Position As a Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical trial portf...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...

What you’ll do - You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and ...

The Business Analyst is part of the Product Strategy team within the Product group helping to guide the current and future business requirements of the MaxisIT CTRenaissance suite of Products as it relates to the internal and external implementation of the product for the companys business customers. In this role the Business Analyst understands existing dynamics, situations, and pain points in the Pharmaceutical / Life Sciences / Biotech / Device industries, including Regulatory, Clinical Repositories, Clinical Operations, Clinical Data Reporting, Dashboards, Metrics, Analytics, and Trial Management Reporting. Supports the creation of roadmaps Participates in Requirements Gathering activiti...