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15.0 - 20.0 years
13 - 17 Lacs
bengaluru
Work from Office
Novo Nordisk Global Business Services (GBS) India Department Commercial DD&IT, GBS Are you passionate about IT validation and compliance? Do you want to play a pivotal role in ensuring regulatory adherence and driving innovation in a global pharmaceutical company? If you have the expertise and enthusiasm to lead in this critical area, we want to hear from you! Read on and apply today. The position As a Lead IT Validation & Compliance at Novo Nordisk, you will be entrusted with the following responsibilities: Ensure IT compliance by monitoring adherence to regulations like GDPR and GxP, aligning systems with evolving standards, and enforcing internal policies. Lead IT system validation by managing the full lifecyclefrom planning to reportingand ensuring compliance through development and review of validation protocols and documentation. Develop and maintain IT compliance frameworks by creating policies, procedures, and documentation, while ensuring accurate records for audits and inspections. Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements. Conduct audits and assessments of IT systems to evaluate compliance, identify gaps, recommend corrective actions, and ensure continuous improvement. Qualifications Bachelors degree in computer science, Information Technology, or a related field, with a total of 15+ years of experience, including 10+ years in IT compliance, validation, or quality assurance within a regulated industry, preferably pharmaceuticals or life sciences. Must have extensive knowledge of GxP, regulatory requirements, and IT system validation processes. Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration. Strong experience in regulatory compliance, validation processes, risk assessment, IT systems, change management, stakeholder collaboration, continuous improvement, project management, and analytical problem-solving. Strong interpersonal, analytical, communication, and collaboration skills, with the ability to represent Novo Nordisk in interactions with users and external stakeholders.
Posted Date not available
1.0 - 2.0 years
3 - 4 Lacs
ahmedabad
Work from Office
Responsibilities and Duties Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP. Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side. Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5. Coordinate with Client to carry out Validation activity of Computerized Systems and Software. Responsible for achieving & maintaining the validated status of in-scope computerized systems Provide guidance on CSV validation issues and discrepancies Support investigation of CSV defects and quality records (deviation, CAPAs). Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions. Coordinating with teammates in achieving assigned tasks. Issue/bug tracking, and software incident management. Develop and execute test plans to ensure that all objectives are met. Implement and monitor test scripts to assess functionality, reliability, performance, and Coordinate and support to Quality Manager. Ensure that user expectations are met during the testing process Documentation adherence to internal/Client SOP and compliance. Managing department functional process as specified in standard operation procedure & suggest changes if required. Qualifications Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist) Excellent written and verbal communication skills. Proficiency with MS Office tools Documentation management Ability to work as a team player in a consulting environment Knowledge of Computer System Validation. Critical thinker and creative mindset and the ability to approach a problem creatively. A meticulous approach to work. A team player but can work independently too. Multi-tasking and time-management skills, with the ability to prioritize tasks.
Posted Date not available
4.0 - 7.0 years
8 - 12 Lacs
pune, gurugram, bengaluru
Work from Office
The Role: This role sits within the (BEV/XHEV) Propulsion System Integration team. The role will focus on delivering data from tests in support of design release activity or technology advancement. The main activity for this role is to ensure successful testing of the propulsion system on rigs and prototype vehicles. This includes liaising with the facilities team to properly build and commission rigs; post-processing data coming off the test properties to confirm pass/fail, writing a test report to document the evidence; triaging and resolving issues identified. Area of Responsibility Validation of systems both on rig and in vehicle within (BEV/PHEV/MHEV) Powerpack across the range of Jaguar Land Rover vehicles Assist and contribute to the verification of targets and methods that are driven by Customer, Function Requirements and Failure Modes and Effects Analysis Contribute to the delivery of the area onto all programmes, in line with the Systems Engineering discipline outlined by Product Creation Systems Provide technical support and assistance across the operational team on topics relating to the integration and harmonisation of multiple interconnected components including issue resolution and objective data analysis Undertake any other work as directed by their line manager in connection with their job as may be requested Knowledge / Experience Essential: Good relevant experience of working in a Systems Engineering test and development environment - ideally within the Automotive Sector Model based engineering (MBE) Requirements and test case Management (RM) Good verbal and written communications Analytical and problem solving skills Track record as an effective team player with strong interpersonal skills Relevant experience of system definition, system architecture development, requirements specification, design/performance modelling, systems integration, system assessment and acceptance Full driving licence Relevant degree or equivalent experience preferred Desirable: Experience in applying Systems Engineering verification and in solving complex technical issues using a structured approach Experience in Model-based Systems Engineering (MBSE) and SysML using IBM Rational Rhapsody Experience in IBM Rational DOORS Class 3 and 4PG driver training level (JLR internal process), or equivalent. Area will support internal process
Posted Date not available
4.0 - 6.0 years
2 - 5 Lacs
chennai
Work from Office
Minimum of bachelors degree in IT, Engineering, or Information Systems or related field required 4+years of experience in Business/Systems Analysis Familiarity with interpreting data and analyzing results using SQL, Excel etc. Strong presentation skills and a very confident communicator Experience working with an ERP solution is preferred Team player: We are a leader in our industry with a start-up mentality and many exciting business initiatives on the horizon. We work as a team to achieve the successful implementation of our initiatives and company goals. You welcome the opportunity to roll up your sleeves and jump into whatever is needed, while balancing varying levels of responsibilities and multiple work streams.
Posted Date not available
5.0 - 10.0 years
8 - 12 Lacs
pune
Work from Office
Job Title: Senior Embedded Test Engineer Python & System Testing- with Medical Domain Job Summary: We are seeking a highly skilled and motivated Senior Embedded Test Engineer with expertise in Python-based system testing and embedded system validation. The ideal candidate will have hands-on experience in automation, hardware-software integration testing, and strong debugging skills for embedded platforms. Key Responsibilities: Design, develop, and maintain automated test scripts using Python for embedded devices Execute system-level testing on embedded products including hardware-in-the-loop (HIL) testing Validate embedded functionalities such as communication protocols (UART, SPI, I2C, CAN, Ethernet), sensors, and actuators Develop test plans, test cases, and test reports as per product requirements and specifications Collaborate with development, hardware, and QA teams to ensure high-quality embedded product releases Debug test failures and identify root causes involving hardware, firmware, or integration issues Work with tools like pytest, Robot Framework, or unittest for automated testing Use test equipment such as oscilloscopes, logic analyzers, and multimeters when needed Required Skills: 5+ years of experience in system testing of embedded systems Strong hands-on experience in Python scripting for test automation Experience with embedded software/hardware interface testing Good understanding of communication protocols: UART, SPI, I2C, CAN, TCP/IP Experience in using tools like pySerial, pytest, unittest, or Robot Framework Familiarity with embedded OS/RTOS (Linux, VxWorks, FreeRTOS) Strong debugging and analytical skills Experience with test management tools (e.g., JIRA, TestRail) Good to Have: Experience in CI/CD integration of test suites (e.g., Jenkins) Exposure to version control systems like Git Familiarity with hardware schematics or PCB understanding Experience with protocol analyzers or simulators Knowledge of Modbus, BLE, or Zigbee is a plus Educational Qualification: Bachelors or Masters degree in Electronics, Computer Engineering, Instrumentation, or related fields
Posted Date not available
8.0 - 13.0 years
11 - 16 Lacs
bengaluru
Work from Office
JOIN US AS A LEAD SYSTEMS ANALYST About the company: As a Fortune 50 company with more than 400,000 team members worldwide, Target is an iconic brand and one of America's leading retailers. Joining Target means promoting a culture of mutual care and respect and striving to make the most meaningful and positive impact. Becoming a Target team member means joining a community that values different voices and lifts each other up . Here, we believe your unique perspective is important, and you'll build relationships by being authentic and respectful. Overview about TII At Target, we have a timeless purpose and a proven strategy. And that hasnt happened by accident. Some of the best minds from different backgrounds come together at Target to redefine retail in an inclusive learning environment that values people and delivers world-class outcomes. That winning formula is especially apparent in Bengaluru, where Target in India operates as a fully integrated part of Targets global team and has more than 4,000 team members supporting the companys global strategy and operations. PRIMARY FUNCTION: At Target in India, our Tax Technology team plays a crucial role in enabling efficient and accurate compliance with US Sales and Use Tax (SUT) regulations. By collaborating closely with the Tax, Product and Tech teams in the US, this team leverages innovative technologies and advanced analytics to enhance operational efficiency and support seamless tax compliance processes. As a Lead Systems Analyst, you will own the compliance data integration, transformation, and load processes, ensuring accuracy, efficiency and seamless operations. You will provide strategic oversight of tax systems, proactively identify improvement opportunities and partner closely with cross-functional teams to enhance automation and analytics capabilities. In addition to SUT, this role will explore opportunities to support income and property tax technology needs. Your leadership in evaluating processes, defining technology-driven solutions and driving execution will be key to optimizing tax operations. This role will also focus on the below areas Lead and oversee the data integration and compliance load processes, ensuring flawless execution, accuracy and efficiency while proactively driving solutions and driving continuous improvements. Drive transparency through documentation and reporting of compliance related issues, identifying trends and working with management to implement corrective actions and long-term enhancements. Act as a strategic partner between Tax, Product and Tech teams to address queries, provide analysis and resolve challenges related to compliance load process, workflows, Vertex returns, SSAS etc. Drive the configuration, testing and validation of tax system updates and integrations to ensure seamless operation and compliance. Establish and enforce data quality controls, ensuring the integrity, accuracy and completeness of tax related data through rigorous analysis, reconciliation and validation. Design and implement Alteryx workflows, leverage tools / language such as SSAS, SQL etc. to streamline tax processes and improve analytics capabilities. Apply innovative solutions including generative AI, machine learning and RPA to automate repetitive tasks and enhance accuracy in tax reporting. Continuously look for opportunities to improve, automate and enhance existing processes for efficiency. Collect and organize required data for audit requests ensuring accurate and timely submissions. Respond to requests for reporting and data from tax users to support sales, income, and property tax compliance and analytics needs. Working within Tax, your mission will be to drive value-added work and support our core retail business goals. Our tax team focuses on all aspects of tax reporting including enhancing productivity and efficiency of core compliance through process and technology, monitoring tax risk and opportunities across all tax disciplines, engaging and educating Finance and the broader organization regarding tax considerations, and prioritizing team resources to support key work streams. 8+ years of experience in tax technology or systems analysis, preferably within a large corporate tax department or consulting firm, with a focus on SUT compliance. Bachelors or Masters degree in Taxation, Finance or Information Systems or an equivalent combination of professional education and experience. Proficiency with tax technology tools and applications including Vertex O-Series, Vertex Returns, Alteryx, SQL and RPA with experience in using these tools to streamline tax compliance, automate workflows and enhance data accuracy and reporting. Experience working on ERP systems (e.g. SAP) and data visualization tools like Tableau or Power BI. Proven ability to collaborate with cross-functional teams, acting as a liaison between Tax, Tech and Product teams to resolve queries and enhance processes. Familiarity with machine learning, generative AI and statistical modeling is a plus. Prior experience of working for a retail organization is strongly preferred. Excellent communication and strong interpersonal skills, as well as the ability to work independently with limited direction and guidance A proactive mindset and keen analytical ability, attention to detail, and the ability to meet tight deadlines.
Posted Date not available
3.0 - 8.0 years
13 - 18 Lacs
bengaluru
Work from Office
Project Role : Business Architect Project Role Description : Define opportunities to create tangible business value for the client by leading current state assessments and identifying high level customer requirements, defining the business solutions and structures needed to realize these opportunities, and developing business case to achieve the vision. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Architect, you will define opportunities to create tangible business value for the client by leading current state assessments, identifying high-level customer requirements, defining business solutions and structures, and developing a business case to achieve the vision. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work-related problems.- Lead current state assessments to identify business value opportunities.- Define high-level customer requirements for business solutions.- Develop business structures to realize identified opportunities.- Create and present business cases to achieve the defined vision.- Collaborate with cross-functional teams to implement business strategies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong understanding of business process architecture.- Experience in business analysis and requirements gathering.- Knowledge of enterprise architecture frameworks.- Hands-on experience in developing business solutions.- Familiarity with project management methodologies. Additional Information:- The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).- This position is based at our Bengaluru office.- A 15 years full-time education is required. Qualification 15 years full time education
Posted Date not available
8.0 - 13.0 years
10 - 15 Lacs
noida, hyderabad, chennai
Work from Office
Operating in a captive set-up, the Senior Program Manager HR(Workday) will act as an internal consultant to HR stakeholders and be part of a team of Workday specialists. Analyze, design, and maintain system configuration for Workday. Serve as a Lead for various Workday modules/functional areas including but not limited to HCM, Recruiting, Compensation, Talent, Payroll and Time, Benefits, Learning actively participate in design, planning and support of Workday. Must be well versed with Enterprise Interface Builder (EIB) Mass Loads. Hands-on experience is a must. Maintain the Workday platform with a focus on reporting (including scheduled reports), business process customization, security administration, data loads and data audits. Comprehension and proficiency of Software as a Service (Saas) design, configuration, and testing in various areas of Workday including but notlimited to Business Process Configuration; Workday security architecture including Domain and Business Process Security Policies; Simple, Advanced, Matrix, and Composite Reporting; Custom Objects; Calculated Fields; Enterprise Interface Builder (EIB), BIRT Reporting. Ability to communicate in a clear and open manner through verbal, written, and non-verbal methods, to all levels of the organization. Good to have Workday Integration support experience as well. Requirements : Experience in HR processes and fundamentals including exposure towards modules of Workday such as Core HCM, Recruiting, Talent, Compensation, Time, and Absence. A minimum of 8 years of overall experience is required, and a minimum of 5 years of Workday experience is required. Preferably 2 + Years of implementation experience in Workday. Role may require extended US support. Excellent communication skills. Kainos Smart Watch Test capability is preferred. Skills Workday HCM, Automated Testing, Cloud Applications, Root Cause Analyses, System Configuration, Systems Analysis Location - Hyderabad,Chennai,Noida,Bengaluru,Gurugram
Posted Date not available
7.0 - 12.0 years
15 - 30 Lacs
hyderabad, pune, bengaluru
Hybrid
India's marquee global technology company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the IT product and service industries. They are a respected career company and a long-term wealth creator. Location: Hyderabad/Bangalore/Chennai/Pune/Mumbai/Delhi/NCR/Kolkata Purpose of the role & key responsibilities: Lead project compliance work streams, responsible for end to end quality and compliance aspect of the project, validation deliverables, client buy-in and reporting leading to successful project delivery and client delight Engage with key stakeholders for execution of day-to-day interactions with client teams Participate in practice development activities Strong business consulting and excellent soft skills Demonstrates proven success in roles and thorough abilities in one or more of the areas. Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5 and SOX IT Subject matter expertise in areas such as Quality Management, document management and Change Management Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry Working knowledge of Risk Management, periodic or control maturity assessment and Audits Must have global client exposure and have worked in Global delivery model Your Profile 5-15 years of computer System validation experience in Life Sciences industry working for a consulting services organization and/or industry experience. Bachelors /Master degree, preferably in pharmaceutical sciences or related field.
Posted Date not available
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