418 Gxp Jobs - Page 9

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...

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturi...

Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should ha...

As a Project Manager at CellChain, you will be responsible for maintaining the chain of identity of personalized CAR-T products from order through revenue recognition and financial reporting. Your role will involve collaborating with product owners, Master data, and DDIT teams to build release and project plans for CellChain. You will assist in planning and launching product features, managing requirements backlog, contributing to the product roadmap, and ensuring system readiness in the context of master data readiness. Your key responsibilities will include working closely with the Customer Enabling Technologies Head to execute against the product vision. You will ensure a shared understan...

Job Purpose Responsible for managing IT infrastructure, operations, compliance, and security across multiple plants/clusters from a central location. The role demands strong project management, cross-functional collaboration, and the ability to solve day-to-day IT issues while ensuring compliance, security, and uptime of systems. Key Responsibilities IT Infrastructure & Operations Management Ensure smooth IT operations across plants, including servers, networks, applications, and security systems. Monitor and support plant IT infra remotely, ensuring business continuity and uptime. Lead upgrades, migrations, and troubleshooting for enterprise IT infrastructure. Manage end-user support for ap...

Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans...

As a Product Owner for ELN platforms such as Benchling, iLab, and Biovia, you will be responsible for defining and managing the product vision, roadmap, and backlog for ELN solutions in the Pharma or Life Sciences industry. Your role will involve gathering and prioritizing requirements from R&D, lab users, and business stakeholders to ensure the successful development and integration of ELN systems. Collaboration with technical teams will be a key aspect of your responsibilities, as you will work closely to drive ELN development, customization, and integration. It will be essential to ensure seamless interoperability of ELN with other lab systems such as LIMS, CDS, and SDMS. Moreover, you wi...

1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation deli...

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 commercial processes, ...

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 7.5 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 commercial processes...

1. Understanding various SDLC (Agile, Waterfall, V) 2. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. 3. Strong experience in Manual and Exploratory Testing. 4. Good experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., 5. Idea on Generative AI for testing 6. Good experience in various testing techniques. 7. Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. 8. Experience in Programming (Java/Python etc.,). 9. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,.). 10. Autom...

1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Good experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation...

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

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit ...