231 Gxp Jobs

Role & responsibilities Contribute to the design and implementation of AI augmented clinical data products (Protocol, ICF, CSR, etc.) and GxP-validated content generation for SDTM, ADaM, and TLG. Support development of Agentic AI solutions for specifications, data mapping, and metadata-driven workflows. Assist in delivering analysis-ready datasets for submission use cases. Collaborate in Agile projects, documenting requirements, writing user stories, and maintaining backlogs using JIRA/Retina. Participate in requirement discussions, creation of specifications, traceability, and user guides aligned with regulatory compliance. Engage with cross-functional teams to support AI-driven biometrics ...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

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...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

Job Role Job Summary: We are seeking a skilled and proactive LabVantage Support Specialist to provide technical and functional support for the LabVantage LIMS (Laboratory Information Management System). The ideal candidate will have hands-on experience in LabVantage configuration, troubleshooting, and user support, ensuring smooth operation and optimal performance of the system across laboratory operations. Key Responsibilities: Provide day-to-day support for LabVantage LIMS users, including issue resolution, troubleshooting, and guidance. Monitor system performance and ensure uptime, data integrity, and compliance with regulatory standards. Configure and maintain LabVantage modules, workflo...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Quality Assurance Compliance Specialist Location: Pune-Hybrid working-Twice a week in the office Status: Permanent, Full Time Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working (with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme. Why are we hiring a Quality Assurance Compliance Specialist? Were on the hunt for a Quality Assurance Compliance Specialist as part of our company’s growth. The Quality Assurance Compliance Specialist provides day-to-day support for Quality Assurance and Information Secu...

Role Overview: As a Senior Specialist Automation Engineer, you will play a crucial role in overseeing the integration of shop floor equipment with IT and OT systems across various domains. Your main responsibility will be to ensure the efficient flow of data from the shop floor to the enterprise level. Working alongside a team of experts, you will be responsible for coordinating and implementing the necessary middleware setup to facilitate data transfer. This will involve defining data points based on specific business requirements and industry best practices. In addition, you will oversee the configuration of end-to-end interfaces and conduct thorough interface qualification processes. Your...

We are a team of SysOps/DevOps engineers with one goal in mind -to keep your online business up and running 24/7. Solving problems is our thing, but we believe that dealing with the same issues over and over again.

TECHNICAL AND JOB SPECIFIC Responsible for Maintaining the manufacturing area Hygiene and cleaned condition. Responsible for ensuring of all-time readiness of manufacturing areas. Ensure that Planning, Warehouse, MES and GMP requirements are included in the scope of the project. Design future Production processes of the plant. Reviews and ensures consistency of projects scopes and priorities. Lead and contribute to the creation of the key decision and user acceptance test. Reports on progresses, risks and opportunities both from project and quality standpoints to a steering committee Lead appropriate escalations as the projects demand. Respect and make GMP standards be respected. During OneE...

TECHNICAL AND JOB SPECIFIC Responsible for Maintaining the manufacturing area Hygiene and cleaned condition. Responsible for ensuring of all-time readiness of manufacturing areas. Ensure that Planning, Warehouse, MES and GMP requirements are included in the scope of the project. Design future Production processes of the plant. Reviews and ensures consistency of projects scopes and priorities. Lead and contribute to the creation of the key decision and user acceptance test. Reports on progresses, risks and opportunities both from project and quality standpoints to a steering committee Lead appropriate escalations as the projects demand. Respect and make GMP standards be respected. During OneE...

Notice Period-Immediate Joiner or Max 10 days (Do not share long notice period profile.) Permanent Payroll - Anlage Infotech Client - NTT DATA Location - Bangalore (Hybrid- 2/3 days in a week) Role & responsibilities - Location: Bengaluru Exp: 5+ years (Relevant) Shift Timings: General Hybrid: 2 to 3 days WFO Mandate Skills: ** CSV, Compliance Gxp, Infrastructure support ** GxP, Compliance , CSV knowledge, Qualification and Maintenance ** Optional Skills: (Good to Have Skills) - Tools exp TIMS, ADO, Servicenow POSITION OVERVIEW : Industry Consulting Consultant POSITION GENERAL DUTIES AND TASKS : Job Description Skill Area: CSV, Compliance Gxp, Infrastructure support Main Technology: Complian...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Build & maintain APIs for EDC (Medidata, Oracle, Veeva) Develop dashboards & role-based UIs Implement workflows for discrepancy management Ensure secure, scalable, user-friendly interfaces Collaborate with ML/Data Engineers for AI-driven insights Required Candidate profile Bachelor’s in CS 4+ yrs full-stack development Backend: Python (FastAPI, Spring Boot) Frontend: React API design: REST/GraphQL, AWS services GxP/regulated software knowledge a plus

Role & responsibilities 1. CSV (Computer System Validation) Develop and execute validation plans, protocols, and reports for computerized systems, including those used in manufacturing, quality control, and distribution. Ensure compliance with regulatory requirements, such as GMP, 21 CFR Part 11, and EU Annex 11. Collaborate with cross-functional teams to identify and mitigate risks associated with computerized systems. Develop, review, and revise SOPs, policies, and procedures related to IT Department. 2. QMS Investigate, document, and track IT-related deviations, including system failures, data integrity issues, and procedural non-compliances. Collaborate with cross-functional teams to ide...

Position Summary: We are seeking a highly experienced and driven Business Analyst to lead and manage Product digital and IT initiatives within the pharmaceutical/life sciences sector. The ideal candidate will have strong experience in Business analysis, stakeholder engagement, and driving execution across multiple workstreams, while ensuring compliance with regulatory and quality standards. ______________ Key Responsibilities: Lead end-to-end product management for IT/technology initiatives in the pharma/life sciences domain, ensuring requirement gathering , gap analysis , process flows modelling documentation practices and technical document writing. Experienced in data analysis (SQL, ETL e...

JOB Description- Role- Computer System Validation Consultant Location- Dadra Responsibilities- 1. Expertise in computer system validation, QMS and IT Compliance. 2. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. 3. Validation experience and expertise in manufacturing, QC and enterprise systems. 4. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. 5. Review the IT activities- Backup report, user access management, Support in internal audit and IT Compliance management. 6. The candidate should have experience in SOP preparation and review. 7. Project and stakeholder management. 8. Periodic review and IT schedule activity management 9. Excellent v...

As a Sr. Technical Architect, you will be responsible for designing and delivering complex enterprise-scale Salesforce solutions for Customers in the Health industry. You will collaborate with teams across different stakeholders to realize a vision and ensure customer success. Your role will involve becoming a deep Health Cloud Domain and Product expert, leading the technical design and implementation of Salesforce solutions, and ensuring compliance with industry regulations (HIPAA, GxP, etc.) and alignment with business goals. You will support the full implementation lifecycle, from scoping to deployment in an evolving ecosystem consisting of clients and partners. Additionally, you will eng...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Life Sciences Good to have skills : Salesforce Development Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Deep expertise in Life Sciences (LS), Veeva CRM, LWC ,Agentforce, and strong Salesforce technical capabilities:Job Summary :We are seeking a Senior Salesforce Technical lead to join our Life Sciences Cloud team. The ideal candidate will have strong hands-on expertise in Salesforce platform development, solid understanding of life sciences com...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Life Sciences Good to have skills : Salesforce Development Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Deep expertise in Life Sciences (LS), Veeva CRM, LWC ,Agentforce, and strong Salesforce technical capabilities:Job Summary :We are seeking a Senior Salesforce Technical lead to join our Life Sciences Cloud team. The ideal candidate will have strong hands-on expertise in Salesforce platform development, solid understanding of life sciences comme...

Job Purpose The Site IT Lead is accountable for strategic and operational IT management at the Vizag facility, ensuring seamless infrastructure, operations, and compliance. The role safeguards information security, supports GxP systems, drives business continuity, and delivers IT excellence in alignment with global standards of a Japanese parent organization in pharmaceutical manufacturing and R&D. Roles & Key Responsibilities IT Infrastructure & Operations Manage IT infrastructure, network, server, and data center operations at the Vizag site. Oversee day-to-day IT operations, helpdesk, and application support. Administer system backups, disaster recovery, and business continuity measures. ...

Position: Veeva Vault QMS Developer Experience 7 Years to 9 Years Employment Type: Full Time Remote Note: If a candidate is strong in Technical, Budget may increase. Key Responsibilities / Skills: Configure and customize Veeva Vault QMS applications Develop objects, workflows, lifecycles, and security policies Create and maintain system integrations (APIs, middleware) Ensure compliance with validation and regulatory requirements Provide technical support during implementation and upgrades Perform system troubleshooting and root cause analysis Create deployment documentation and user guides Collaborate with BAs, QA, and business teams for solution delivery Hands-on experience with Vault APIs ...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Life Sciences Good to have skills : Salesforce DevelopmentMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time educationDeep expertise in Life Sciences (LS), Veeva CRM, LWC ,Agentforce, and strong Salesforce technical capabilities:Job Summary :We are seeking a Senior Salesforce Technical lead to join our Life Sciences Cloud team. The ideal candidate will have strong hands-on expertise in Salesforce platform development, solid understanding of life sciences commerc...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is looking for passionate and experienced Product Owners to join our rapidly growing team. Your focus will be on the overall success of aValGenesis product line and strategy. You will work...

Job Description : Senior IT Project Manager (Windchill 13 Upgrade) About the Role We are seeking a Senior IT Project Manager with strong expertise in PLM (Product Lifecycle Management), particularly PTC Windchill, to lead a major global Windchill v13 Upgrade Project. This is a strategic program within the healthcare and life sciences industry, with high visibility and impact. Key Responsibilities Lead the planning and execution of a Windchill v13 upgrade, ensuring business continuity, platform modernization, and compliance with regulatory requirements. Develop detailed project plans and implementation schedules, incorporating PMBOK standards and stakeholder requirements. Manage change contro...