418 Gxp Jobs - Page 14

SAP FI - Treasury Risk and Cash Liquidity Mgmt - Expert proficiency in SAP FI Treasury - Ability to read through the customer business processes and simultaneously formulating the adoption of the best business practices in meeting the foreseeable challenges Ability to review, validate the right set of questions Create solution workshops with senior business managers, review validate solutionproposals and estimates, rendering advice on best business practices and getting the buy in to adopt these practices Ability to create solution road maps integrating multiple disparate processes Ability to present and get the buy in forthe solution from senior managers Implement the solution by leading th...

SkillSAP FI-FSCD LocationPune and Bangalore Minimum of 4 years SAP experience Configure G/L, A/P, A/R, Asset Accounting, Interface Integrations, Experience on Collections and Disbursements (FS-CD) Experience providing application support Relevant SAP certifications are a plus Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of clients network/ server/ system/ storage/ platform/ infrastructure and other equipments to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the ...

Location- Novo Nordisk Global Business Services (GBS), Ahmedabad, India Department- GCM Operations Drug Product Are you ready to take charge and make a difference in the pharmaceutical industryIf you’re a dynamic person with a passion for quality and operational efficiency, you might be our new Operations Manager. The position is based in Ahmedabad in India and will report directly to GCM organization based in Denmark. Apply today and get life changing career! Apply now! The position As an Operations Manager, you will be responsible for ensuring Novo Nordisk’s interests with regards to short to midterm capacity, compliance, quality, manufacturing readiness and activities at the CMO. You will...

Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufact...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least ...

Key Responsibilities • Design end-to-end data workflow architecture using Alteryx Designer, Server, and Connect. • Translate HLS use cases into technical workflows, including patient journey analytics, claims automation, and real-world evidence processing. • Integrate Alteryx with cloud platforms, EMR systems, SQL-based data warehouses, and visualization tools. • Ensure compliance with HIPAA, GxP, FDA, and other regulatory standards. • Guide the data governance, security, and quality framework across solutions. • Collaborate with clinical analysts, data scientists, and IT to deliver analytics solutions aligned with business goals. • Provide thought leadership, mentor junior Alteryx resources...

Job title: Product Owner: Enterprise Access Management. About The Job. Our Digital ambition at Sanofi. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. Digital is at the heart of Sanofi: our ambition is to be the leading digital healthcare platform to develop & deliver medicine faster, enable healthcare professionals to improve treatments and help patients improve their health. At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before.. What You Will Be Doing. Ac...

Job Title: Validation Tester. Job Type: Full-Time. Location: Remote. Job Summary:. Join our customer's team as a Validation Tester and play a critical role in ensuring software quality and regulatory compliance. As a key member of our QA process, you will collaborate closely with developers and stakeholders, leveraging your expertise in validation testing and regulatory standards to drive product excellence.. Key Responsibilities:. Design and implement comprehensive test cases and scenarios using risk-based testing methodologies, with special emphasis on core functionalities and regulatory requirements.. Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningfu...

Role and Responsibility Responsible for delivering and managing successful SAP Roll Outs for Accord Entities PP/QM Module Design, Implement and Deploy SAP / Technical Solutions to achieve business goals Coordinate and communicate with business / Support Partner (Sajen) team to ensure that all incidents are resolved well in time (as per agreed SLA) and all Change Requests are delivered as per agreed timelines Support and Guidance to Support Partner (Sarjen) team wherever required so that business is not interrupted Training to Business users & Support Partner (Sarjen) team wherever required for desired skills Ensure IT controls, SOD conflicts Periodic Review of issues, communication with busi...

Role and Responsibility Responsible for delivering and managing successful SAP Roll Outs for Accord Entities MM/EWM Module Design, Implement and Deploy SAP / Technical Solutions to achieve business goals Coordinate and communicate with business / Support Partner (Sajen) team to ensure that all incidents are resolved well in time (as per agreed SLA) and all Change Requests are delivered as per agreed timelines Support and Guidance to Support Partner (Sarjen) team wherever required so that business is not interrupted Training to Support Partner (Sarjen) team wherever required for desired skills Ensure IT controls, SOD conflicts Periodic Review of issues, communication with business, escalation...

We are seeking a highly skilled and motivated Senior Analyst - Service Delivery Manager to oversee the services of our research applications and all associated service delivery activities in the Healthcare sector. In this role, you will foster a deep level of communication with the business teams to ensure effective solutions and high customer satisfaction. Have Outstanding verbal and written communication skills, along with the ability to understand service requests and incidents in healthcare, are key success factors. Manage end-to-end service delivery for resource applications, ensuring alignment with client expectations and business goals. Collaborate with cross-functional teams, includi...

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. Your role 1. Experience of agile methodologies such as Scrum, Kanban, etc and knowledge of scaled frameworks like SAFe etc. 2. Experience in tracking and publishing different metrics regularly to various stakeholders like Sprint reports, Status,...

Title : GXP Validation Testing | 4 to 18 years | Mumbai, Pune, Hyderabad & Bengaluru Design, develop, and execute test cases, test scripts, and test plans based on project requirements. Conduct functional, regression, integration, and acceptance testing. Track and document defects, issues, and ensure timely resolution. Collaborate with cross-functional teams to understand requirements and provide feedback on system designs. Ensure all manual testing activities are documented according to company policies and standards. Apply GXP testing practices (Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices) to ensure software meets regulatory compliance and industry stan...

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 a passionate and experienced Product Management to join our rapidly growing team. In this role, you will help define the product strategy and roadmap for our product lines. ...

Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations an...

Roles and Responsibilities : Develop and maintain GXP (Good X Practices) documentation for pharmaceutical processes, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to identify areas for improvement in CSV (Commercial Specifications) and implement changes as needed. Conduct audits of manufacturing facilities to ensure adherence to cGMP guidelines, identifying non-conformities and implementing corrective actions. Provide training on GAMP (Good Automated Manufacturing Practice) principles to production staff. Job Requirements : 1.5-5 years of experience in a pharmaceutical or life sciences industry setting. Strong understanding of GXP, CSV, gGMP, and G...

Labware LIMS Functional consultant with experience in Labware LIMS, Labware ELN, Labware Mobile, LIMS V7, Implementation, rollouts, GXP, FDA, ISO,

Role & responsibilities Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written) Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma...

Project Role : Security Delivery Lead Project Role Description : Leads the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets). Must have skills : Cloud Security Architecture Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Security Delivery Lead, you will lead the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets).We have a requirement for an AWS Cloud Security Engineer to join our growing cloud security team within a leading global pha...

What you will do In this vital role you will take ownership of Transportation Master data processes, ensuring the accuracy, consistency, and governance of critical data across the organization. This role will lead data validation, cleansing, and enrichment efforts, and collaborate with cross-functional teams to resolve complex data issues and drive process improvements. The Transportation Master Team Lead will also oversee key performance metrics, ensure compliance with data governance standards, and lead data migration and integration initiatives. Roles & Responsibilities: Lead and manage day-to-day MDM operations, including data validation, cleansing, and enrichment processes Oversee data ...

Req ID: 324406 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft ...

Req ID: 324412 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft ...

Eligibility Relevant Experience : 7 -15 Years, Notice Period: 0 -30 days Locations: Hyderabad/Bangalore/Chennai/Pune/Mumbai/New Delhi Work Mode: Work From Office/Hybrid Job Description Minimum 2-3 End to End Green Field Implementations on SAP SCM(s/4HANA) Essential Skills and Experience Experienced SAP Supply Chain consultant with exposure to PPDS and how the two products are used in conjunction with required master data. Previous experience in triaging SAP incidents, and liaising with end users to identify and resolve issues. Good communication skills including liaison with various stakeholders via video calls and Emails. Experience of working in regulated environments (e.g. pharmaceutical)...

Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook...