408 Gxp Jobs - Page 3

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

MES Service Delivery Manager Were seeking an MES Service Delivery Manager to oversee the delivery, support, and continuous improvement of Manufacturing Execution Systems across global manufacturing sites. Key Responsibilities: Manage MES operations, SLAs, and incident resolution across sites. Coordinate between business, IT, and vendor teams to ensure seamless service delivery. Ensure adherence to GxP, quality, and regulatory compliance standards. Drive performance improvements and process optimization initiatives. Functional and technical expertise in MES and QMS systems. Oversight of SLAs, compliance, and continuous service improvement. Key Skills: MES , QMS, Service Delivery, ITIL, GxP Co...

Requisition Id 1650367 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that its your career and Its yours to build which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity Senior Consultant-FS-SaT-SaT - S&E - Corporate Strategy - Mumbai...

The opportunity We have new opportunities for ambitious individuals to join our Tax Team. You will receive extensive training and support from a variety of leading tax professionals to assist you in building a successful career in Tax service line within EY. Your key responsibilities Your client responsibilities Review of tax returns, tax provisions, and work papers. Review of audit of tax deliverables prepared by tax analysts / advanced tax analysts. Act as first level reviewers of products that are finally reviewed by the engagement teams, thus acting in the role equivalent to a counter part in the Ireland. Successfully monitor the engagement team against the plan and budget. Adhere to the...

To review the code for implementing and designing the system/application. Implement new solutions / services as per customer and business requirements. Coordinate with alliance / partnership to generate new / grow revenue. Participate in developing unique IPs, building new services/ solutions to market position and roll out within the unit. Develop sales collateral and marketing materials. Be involved in developing effort estimation & pricing models for productized solution / services. Ensure the sustenance of practices by effective governance. Accountable for accurate budgeting, accounting and billing of engagements. Ensure compliance to internal tools like CDI, Optima as applicable. Identi...

Role Overview: As the eCompliance Manager at Novartis Healthcare Private Limited, your primary responsibility is to provide Quality Assurance oversight and guidance regarding computerized systems validation (CSV) within the framework of regulations such as GxP, 21CFR11, etc., as well as the requirements defined in the Novartis Quality Manual and global procedures. You will be involved in approving GxP impacted changes, Periodic Review Reports, deviations, and providing guidance on CSV-related topics to the project and operations team. Additionally, you will review and approve global Computerized Systems key validation deliverables as part of the eCompliance support to GxP projects. Key Respo...

Sanofi MSAT Transformation Over the past few years, Sanofi has launched an ambitious digital transformation program of its industrial processes, particularly within the MSAT and Engineering teams. This transformation aims to enhance the agility, reliability, and efficiency of technical and scientific operations across the entire industrial network. As part of the strategic Launch Engine program, one of the key pillars is the deployment of the iCapture solution. This digital product enables the digitization, standardization, and automation of critical data capture throughout the product lifecycle, from development to commercial production. iCapture serves as a Core Model for technical data ma...

Area Electrophoresis, Immuno Assay and Instrument based test. Role • Responsible for Electrophoresis, Immuno Assay and Instrument based test. • Responsible for Sample Management and related documentation. Job Responsibilities : • Responsible for Sample Management (Batch and Control Samples) and related documentation. • Performance of the SDS-PAGE, Western Blot and Immuno blotting, miscellaneous test for biotech products. • Performance of the daily basis calibrations and verification of equipment. • Communicate to cross functional department for the planning, execution and documentation. • To follow and maintain the Quality system and procedure in lab as per Regulatory Requirement. • To prepa...

Job Description Summary About GE Grid Solutions: At GE Grid Solutions we are electrifying the world with advanced grid technologies. As leaders in the energy space our goal is to accelerate the transition for a more energy efficient grid to full fill the needs of tomorrow. With a focus on growth and sustainability GE Grid Solutions plays a pivotable role in integrating Renewables onto the grid to drive to carbon neutral. In Grid Solutions we help enable the transition for a greener more reliable Grid. GE Grid Solutions has the most advanced and comprehensive product and solutions portfolio within the energy sector. Why we come to work: At GE Renewable Energy, our engineers are always up for ...

Job summary As a Pharma IT - CSV, you will be responsible for the validation of all GxP-relevant computerized systems used across manufacturing, quality control, and R&D. Your role is critical in ensuring all IT systems meet regulatory requirements from agencies like the US FDA, MHRA, and others. You will manage the entire system validation life cycle, from planning to retirement, within a highly regulated pharmaceutical environment. Responsibilities Validation life cycle: Plan, execute, and document computer system validation activities in accordance with GAMP5 guidelines and internal Standard Operating Procedures (SOPs). Regulatory compliance: Ensure all computerized systems and processes ...

As an MES Analyst at NNE in Bangalore, India, you will be a part of the Manufacturing IT team, supporting the development of master batch records (MBRs) in the MES system for pharmaceutical and biotech industries. You will play a crucial role in delivering digital factory solutions and ensuring compliant, efficient, and future-ready manufacturing operations. Your responsibilities will include: - Supporting Lead/Senior/Advanced MES Analysts in designing/developing workflows, recipes, and master data using PAS-X MES system. - Integrating MES (PAS-X) and DCS (800xA) systems for seamless batch execution, data integrity, and traceability. - Resolving queries related to the preparation & execution...

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...

This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead technical activities for the solutions that re-define how Novartis operates, You will be working on strategic initiatives with the mandate to deliver solutions, which will bring transformative change to the business domain and will allow Novartis to realize a competitive advantage, About The Role Position Title Assoc Dir DDIT DEV RA Sol Arch, Location Hyd-India Hybrid About The Role This role purpose is to act as a consultant and advisor providing guida...

Lead the transformation of business requirements into IT solution design specifications, implementing data ingestion and integration solutions on data platforms to meet customer expectations Ensure solutions are reliable, scalable, and flexible Act as a Data Engineering Lead for cloud data platforms, supporting development activities for the SPINE program Engage with internal and external IT partners, leveraging business and technical knowledge from various teams and functions to determine requirements and deliver data-driven solutions and recommendations to improve efficiency and add value About The Role Position Title Associate Director Data Science (Assoc Dir DDIT DEV TRD Data Integration...

The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc) and requirements defined in the Novartis Quality Manual and global procedures, eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc, Provides the guidance to the project and operations team on the CSV related topics and related information Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects, About The Rol...

As an eCompliance Manager at Novartis, your role involves providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) within the framework of regulations such as GxP, 21CFR11, and other relevant requirements outlined in the Novartis Quality Manual and global procedures. Key Responsibilities: - Oversight of operational activities of GxP systems including managing changes, periodic reviews, and deviations - Providing necessary support to ensure compliance with Novartis and regulatory requirements for GxP regulated computerized systems projects - Acting as the main point of contact for all CSV related matters for GxP Computerized Systems and bridging the g...

As a SAP ECC Functional Consultant, you will be responsible for leading functional activities for ECC company code rollout in a greenfield environment for a leading pharmaceutical client. Your role will also involve preparing for a future S/4HANA conversion, requiring awareness of the S/4HANA landscape and delta changes. Collaboration with business stakeholders, gathering requirements, performing detailed analysis, and ensuring compliance with pharma industry standards will be key aspects of your role. - Lead functional activities for ECC company code rollout in a greenfield environment. - Work closely with business stakeholders to gather requirements and perform detailed analysis. - Prepare...

Job Title: Manager, Digital Initiatives Job Grade (refer to JE) G10 Function: Global IT Sub-function: Manufacturing IT Location: Mumbai Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job ...

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...

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...

Role Application Support Engineer Shift – Rotational ( Night/Afternoon shifts) Location - WFH Experience with software support or software development Proven experience as a team player Experience with Agile software development Experienced with Application support Effective communication skills Experience in a drug discovery or scientific research setting preferred Vest Technical knowledge on AWS, UNIX, Windows, Web services, REST API, Java, .Net, Middleware, Oracle, Mongo, MSSQL, network Good Domain/Application knowledge on Animal Management (Topaz and MOSAIC), Clinical, LIMS, Sample Management, Instrument, Pristima, Telemetry, Archiving SDMS Good troubleshooting skills. Customer focused G...

Role Overview: As a Solution Architect, your role will involve 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 4HANA. Key Responsibilities: - Conducting systematic client workshops to derive key design decisions with industry best practice recommendations. - Leading engagement efforts at different stages from problem definition to solution design development and deployment in large S 4 HANA transformation programs. - Creating detailed design and architecture, process artifacts, and implementing the...

As Manager - Office of Data Reliability at Sun Pharmaceutical Industries Ltd, your role involves critically reviewing data and documents from Analytical Research and Product/Packaging development departments for submission to USFDA. Your responsibilities include: - Perform a thorough review of raw data related to R&D activities such as Analytical Method Validations, Analytical reports, and Product Development Reports to ensure accuracy and integrity for regulatory submission. - Review supporting documents like user log books and electronic data related to USFDA submission. - Ensure compliance with employee Certification for all R&D data intended for USFDA submission. - Coordinate with stakeh...

Role Overview: As a Solution Architect-SAP Production Planning at Percipere, you will be pivotal in designing, constructing, and enhancing end-to-end SAP manufacturing processes for clients" enterprises. Your role involves leading large-scale transformation projects, facilitating client workshops to drive design decisions, and engaging in all stages of solution development and deployment within S/4 HANA transformation programs. Additionally, you will establish and maintain strong client relationships while contributing to various organizational initiatives. Key Responsibilities: - Lead transformation projects in the manufacturing workstream, focusing on PP object data migration in S/4 HANA. ...