231 Gxp Jobs - Page 2

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 ...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

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 applicationssupporting 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 stakeholders to optimize business processes and system fu...

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Design, Build & Optimize End to End SAP Manufacturing Processes for customers enterprise Leading large scale transformation projects Manufacturing Workstream leveraging experience including PP object data migration experience in S/4HANA Conduct systematic client workshops to drive & derive Key Design Decisions with Industry best practice recommendations As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and a...

Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEsing potential problems (environments include Sandbox, Development, QA and Production). Additional Responsibilities: SAP BASIS with experience in any of the following industry (Pharma, Professi...

About Shalina Healthcare: Shalina Healthcare is among the largest privately owned pharmaceutical businesses in Africa with its Global Headquarters based in Dubai, UAE. The company has recently diversified into new lines of businesses such as Digital Healthcare, Diagnostics, and Consumer Healthcare. Shalina Healthcare has a remarkable track record and its brands are highly trusted across Africa. With a vision to become the health champion of Sub-Saharan Africa by 2030, the company is seeking individuals who can contribute to its growth and make a positive impact on the communities it serves. If you share our Core Values and are passionate about our Mission, we welcome you to join us on this j...

You will be working as a Lead-SAP Production Planning at Percipere, an established Premier Process Integrator based in the UK with a fast-growing presence in Europe, America, Middle East, and India. The role is based in Mumbai and is crucial in achieving the ambitious growth targets set by the organization. Your responsibilities will include designing, building, and optimizing end-to-end SAP Manufacturing Processes for customers" enterprise. You will lead large-scale transformation projects in the Manufacturing Workstream, leveraging your experience in PP object data migration in S/4 HANA. Conducting client workshops systematically to drive key design decisions with best practice recommendat...

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with ...

OVERALL OBJECTIVES: As a senior member of the team, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Primary focus is the assessment, planning and implementation of new or improved IT Services as part of the project engineering team. Senior Reliability Engineer (SRE) is primarily responsible for the engineering, configuration, installation, and maintenance of; Windows physical and virtual servers, Active Directory, Azure cloud and on-prem environments based on Hyper-V/VMWare, storage, backups, and disaster recovery planning. We rely on our engineers to empower our users with high availability, excellent performance levels and key serv...

Job Description Summary: Leads and supports establishing and maintaining the GxP management system of the ARD Line Units at site level, serves as a contact point between local QA and the local ARD Line Units for general inquiries, represents the ARD in GxP-related committees and networks. Lead and manage all compliance/project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. Responsibilities include, but are not limited to: Oversee and lead all activities of assigned teams /projects to meet customer needs. Work according to appropriate standards for quality, ethics, health, safety, environment, protection and i...