73 Csv Jobs

Maintenance and Projects in API division Candidate having Good Knowledge of CSV Validation as per GMP-5 Green Field and brown field project knowledge Knowledge of instrumentation calibration like , TT,PT,FT,RTD operation and maintenance of all pharmaceutical control instrumentation, Programming and troubleshooting. Designation : Officer/Executive/Senior Executive Experience: 02-07 years

Responsibilities: * Execute tests using QA tools * Ensure compliance with CSV & SOP standards * Collaborate on training management initiatives * Monitor quality through QMS processes * Report defects promptly Overseeing all training activities . Health insurance Maternity policy Gratuity Provident fund Maternity leaves Paternity leaves Job/soft skill training

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

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 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

Over 5+ yrs exp in Sterling Integrator, EDI X12, map dev (XML, EDIFACT, IDOC, CSV), partner onboarding, logistics EDI (204, 210), BP dev, MFT, and daily EDI ops with B2B/ERP teams. contact no : 9063478483/9063478481

Work Experience :4 to 8 Years. Work Timings: Rotational Shift. Location: Remote. Spektra Systems is seeking a support specialist for providing technical support for trainings and events happening through it’s platform CloudLabs. You’d be a part of a dynamic team responsible for building and supporting many of labs and workshops every month. This profile is for technical support to instructors and learners doing Microsoft Azure, Microsoft 365 and related technologies lab.. This role is perfect fit for someone interested in becoming a technical journalist (jack of all), 50% of your time will go in learning modern cloud technologies and rest 50% in supporting them.. Responsibilities:. Learn and master the labs offered by Spektra Systems through CloudLabs platform. It includes a wide range of technologies around Azure, M365 and related cloud platforms.. Troubleshoot technical issues faced by learners and instructors during and prior to the workshop.. Provide phone and chat-based support during workshops. Maintain customer communication and ensure client satisfaction during and prior events. Learn Cloud Technologies over the time and provide technical support for cloud technologies.. Test the Labs and scenarios to ensure we are always up to date.. Optimize the lab environment and experiences.. Build and test Automation using ARM templates, PowerShell/Shell Scripts etc.. Desired Profile (Implementation/Support Experience, Expert knowledge, and/or ownership of):. You should have deep expertise in one or more technologies from the below and should be open to learn other technologies.. Azure IaaS and PaaS Solutions. Microsoft 365. Identity Solutions (Azure AD, Windows AD). Automation Including ARM Templates PowerShell scripts, Shell scripts etc.. DevOps Fundamentals. General Networking. Microsoft Infrastructure and Server technologies: Windows Server OS, Active Directory, DNS/DHCP/Fileserver etc.. Virtualization: Hyper-V, CSV, Storage Spaces, Virtual Networking, Migrations etc.. Windows Server: OS, DNS, AD, DHCP, File Server. Linux Server OS: Linux (primarily CentOS, and Ubuntu). Pub/Priv keys, SSH, PuTTY, etc., Linux/Unix command line, LAMP stack.. AWS Fundamentals. GCP Fundamentals. Additional Specifications:. Night-shift Schedule (there could be rotation depending on schedule).. Provide voice and chat-based support.. Ability to work independently with minimal direction; self-starter/self-motivated.. Excellent written and Verbal communication skills.. Show more Show less

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A

JD: Mandatory Skills - ITIL, CSV, Process Management, Change Management, Pharma, audit, Compliance & Any certificate ITIL V3 / ITIL V4, CAPA, RCA Global Quality IT Manager Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.

SUMMARY This is a remote position. About Us At Contour Education, we’re reshaping how students learn one small group at a time. Since launching in 2020, we’ve helped over 6,000 students succeed in their school assessments and final exams through dynamic small-group tutoring, supported by a team of 250+ onshore and 70+ offshore staff. Our India-based offshore team has been critical in delivering high-quality academic content, operations, and tech support at scale. As we continue to grow, we’re investing heavily in systems automation to build a more scalable, data-driven operation that supports thousands of student journeys. We’re currently transitioning from Monday.com to HubSpot as our core CRM and operations platform and we’re setting up our automation infrastructure from the ground up. This is your opportunity to join at the earliest stage, lay the foundation, and become the internal expert on how our platforms connect and communicate. Recognized three years in a row by the Australian Financial Review as one of Australia’s Fastest Growing Startups, Contour is entering its next phase and automation is at the heart of it. Why Join Contour? Automate Impact, Scale Innovation & Power the Future of EdTech At Contour, we’re not just building an EdTech company we’re reshaping how students discover and connect with high-quality learning experiences. As an Automation Engineer, you’ll be a vital part of our tech backbone, ensuring our platforms run smoothly, efficiently, and at scale. You’ll design, develop, and maintain automated testing frameworks and workflows that help deliver a seamless experience for our students and educators. This is a rare opportunity to join at a foundational stage and play a critical role in building robust, scalable systems that support Contour’s growth across India and beyond. You’ll work closely with India-based and global product and engineering teams to improve reliability, speed up releases, and empower the entire organization to innovate faster all while contributing to Contour’s mission of delivering accessible, world-class education. As an Automation Engineer , you will: Be part of a system overhaul migrating from Monday.com to a fully integrated HubSpot-powered ecosystem Play a foundational role in building internal automations from scratch Use cutting-edge tools like n8n , Make.com , and Zapier to drive real operational efficiency Collaborate with multiple departments including Sales, Marketing, Academics, and Operations Enjoy a fully remote setup with high autonomy and fast decision-making. Help power high-impact processes that support thousands of students If you’re a detail-driven problem solver who thrives in fast-paced environments, enjoys building scalable systems, and wants to play a meaningful role in powering seamless educational experiences for students Contour is the place for you. Role Overview Streamline Systems, Scale Reliability & Power EdTech Innovation As an Automation Engineer, you’ll be responsible for designing, implementing, and maintaining the automation workflows that connect our internal systems. Your work will directly impact our efficiency, data accuracy, and team productivity across all business units. Key Responsibilities Workflow Development Build and maintain automation workflows using tools like n8n, Make.com, and Zapier Integrate platforms such as Google Sheets, HubSpot, Slack, and other SaaS tools CRM Transition & Integration Support the migration from Monday.com to HubSpot by setting up key automation flows Develop robust integrations using APIs and webhooks to automate CRM functions Ensure seamless data syncing between platforms Data Management & Reporting Automate data collection, processing, and reporting workflows Create PDF generation and email dispatch systems for reporting and communications Set up automated invoicing and billing solutions System Optimization Monitor automation health, debug issues, and improve reliability Continuously evaluate and improve system performance and workflow efficiency Collaboration & Documentation Work closely with cross-functional teams to understand automation needs Document all workflows and provide training to non-technical stakeholders Requirements Must-Haves 3+ years in automation, workflow engineering, or systems integration Strong hands-on experience with n8n , Make.com , and/or Zapier Familiarity with APIs, webhooks, and common data structures (JSON, CSV) Experience with Monday.com, HubSpot, Google Sheets, and document tools High attention to detail and strong problem-solving skills Self - starter who thrives in a remote-first, fast-paced environment Nice-to-Haves Basic knowledge of JavaScript or Python Experience in a cross-functional or startup environment Exposure to automation involving CRMs, LMSs, or other education platforms Benefits Work-From-Home Setup: Enjoy the flexibility and comfort of working remotely from anywhere in India, supporting a healthy work-life balance. Flexible Hours, High Trust: Join a low-bureaucracy, high-accountability environment where you own your schedule and your outcomes. High-Impact Engineering Role: Be part of the core tech team building automated systems that improve reliability, speed, and scalability across our EdTech platform. Growth & Ownership: Expand your scope into platform-level engineering, test architecture, and DevOps practices as you grow we promote from within. Cross-Border Collaboration: Work with a smart, kind team of engineers, product managers, and educators across India and Australia. Make a Real Impact: Help shape the backend infrastructure of one of Australia’s most exciting EdTech companies and directly support the learning journeys of thousands of students. Competitive Compensation: Receive a market-leading salary of 10-15 LPA with performance-linked growth opportunities. Ready to shape the future of education at Contour? Apply now to join one of Australia’s fastest-growing EdTech companies and play a crucial role in building reliable, scalable systems that power world-class learning experiences while helping drive Contour’s global tech evolution.

The Team: The OSTTRA Technology teamis composed of Capital Markets Technology professionals, who build,supportand protect the applications that operate our network. The technology landscapeincludeshigh-performance, high-volume applications as well as compute intensive applications,leveragingcontemporary microservices, cloud-based architectures. The Impact: Together, we build, support, protect and manage high-performance, resilient platforms that process more than 100 million messages a day. Our services are vital to automated trade processing around the globe, managing peak volumes and working with our customers and regulators to ensure the efficient settlement of trades and effective operation of global capital markets. Whats in it for you: The role will primarily focus on delivering implementations & integrations. This position may additionally be required to produce cross-training materials in the agreed, standardised formats; take on primary & secondary responsibilities when delivering implementations & integrations with other team members; and engage in product UAT cycles. Specialist - Professional Services at all levels are expected to collaborate with other members of professional services, and other internal teams, in order to deliver implementations & integrations. The expected working hours in Gurgaon are 12 - 9pm. Some tasks, such as deployment of changes, is required on Sundays as part of the role. This is an excellent opportunity to be part of a team based out of Gurgaon and to work with colleagues across multiple regions globally. This role is being hired to support new initiatives within OSTTRA. Responsibilities: Implementation & Integration Deliver implementations & integrations for multiple project types across the services (currently limited to ex. Traiana services) offered within the FX&S pillar at OSTTRA Hand over to the operations teams once live Day one check in with the customer Finalising readiness to migrate to production, and liaising with the relevant counterparties (as required) Undergoing the UAT phase with the customer directly, unilaterally identifying issues, investigating those issues, and resolving those issues with the relevant internal or external team Gathering & setting up all required static data in UAT & production (as required) System configuration in UAT and production environments Connectivity & integration set up in the product Connectivity & integration set up in IC and/or Adapters Coordinate the development of the transformer based on the spec provided by Solution Design Create any required routing in IC Ensure that all integration changes & set ups undergo the required 4-eye checks prior to deployment in production Ensure all integrations follow the integration standards outlined Work effectively as part of a professional services project team on each implementation and/or integration, alongside a project manager and solution design manager Work effectively with key internal stakeholders outside of professional services during the implementation and/or integration, such as the connectivity team, product or development teams Demonstrate a positive customer experience during implementations & integrations, regardless of whether the Technical Project Manager leads discussions or is working behind the scenes on items Update the PSA system (e.g. Monday.com) on a daily basis so that the project manager has the correct information on project status, risks, issues and dependencies Creating and tracking UAT plans Ensure all required implementation & integration documentation is produced in the standard formats defined, and is made available prior to the point of go-live, including the operations handover material Effectively manage time so that tasks are completed by the expected due date Cross-Training Create cross-training materials in the pre-defined standardised formats on implementation & integration processes for project types To lead implementation & integrations as a primary resource, while developing a secondary resource Develop new core skills, and take on new project types To assist a primary resource during implementation & integrations, while acting as a secondary resource Where necessary during the professional services restructure, assist with other teams in their cross-training priorities and needs Teamwork Responsive, collaborative and engaged with the internal project management team assigned to each implementation and/or integration Engage, be open and be objective in post-project retrospectives to develop the team further Product UAT Executing the required UAT runbook Operations Escalations Act as an escalation point for certain project types services from a technical project management perspective What Were Looking For: Knowledge of a message formats such as FIX, XML, JSON or CSV Work effectively as part of a team Ability to define and document detailed workflow processes Process-oriented with excellent organisational skills Ability to fulfil required project tasks in a timely manner Customer facing skills Creative problem solver Excellent verbal and written communication skills Understanding of the services offered by the OSTTRA FX & S pillar

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 and industry best practices. Ensure validation lifecycle management, including periodic review, re-validation, and change control assessments. Collaborate with IT, Quality, Engineering, Production, and external vendors to ensure smooth implementation and validation of new computerized systems or upgrades. Drive data integrity initiatives and compliance across computerized systems and related workflows. Conduct internal audits, gap assessments, and readiness checks for regulatory inspections related to CSV. Provide training and guidance to cross-functional teams on CSV policies, procedures, and regulatory updates. Track regulatory developments and industry trends to continuously improve CSV and data integrity frameworks Preferred candidate profile B.E./B.Tech or a Masters in Pharmacy with 12 - 16 years of experience in Computer System Validation within regulated pharmaceutical manufacturing, preferably injectable / sterile dosage forms. Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Hands-on experience with LIMS, ERP, SCADA, BMS/EMS, and electronic batch records. Experience in handling regulatory inspections (e.g., USFDA, MHRA, EU, WHO) from a CSV perspective

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 GAMP principles. Ability to work effectively in a fast-paced environment with multiple priorities.

GRole & responsibilities The person should have knowledge & experience of 5 to 6 Years on Computer System Validation. Preferred candidate profile Hardware and software related trouble shoots. GAMP-5 guidelines,the approaches upto retirments to maintainthe computer System. backup system managments in production equipments from PLC and analytical instrument data in quality control. Restore the backup data and to check periodically the data is correct PLC Validation. The proper connectivity of cabels & to provide proper printing facility. Data migration Overall It experience to comply cGMP required in pharmaceutical products. Perks and benefits Meal,Transport,Mediclaim,GPA,

About the Role In this opportunity, as Senior Data Engineer, you will: Develop and maintain data solutions using resources such as dbt, Alteryx, and Python. Design and optimize data pipelines, ensuring efficient data flow and processing. Work extensively with databases, SQL, and various data formats including JSON, XML, and CSV. Tune and optimize queries to enhance performance and reliability. Develop high-quality code in SQL, dbt, and Python, adhering to best practices. Understand and implement data automation and API integrations. Leverage AI capabilities to enhance data engineering practices. Understand integration points related to upstream and downstream requirements. Proactively manage tasks and work towards completion against tight deadlines. Analyze existing processes and offer suggestions for improvement. About You Youre a fit for the role of Senior Data Engineer if your background includes: Strong interest and knowledge in data engineering principles and methods. 6+ years of experience developing data solutions or pipelines. 6+ years of hands-on experience with databases and SQL. 2+ years of experience programming in an additional language. 2+ years of experience in query tuning and optimization. Experience working with SQL, JSON, XML, and CSV content. Understanding of data automation and API integration. Familiarity with AI capabilities and their application in data engineering. Ability to adhere to best practices for developing programmatic solutions. Strong problem-solving skills and ability to work independently. #LI-HG1 Whats in it For You Hybrid Work Model Weve adopted a flexible hybrid working environment (2-3 days a week in the office depending on the role) for our office-based roles while delivering a seamless experience that is digitally and physically connected. Flexibility & Work-Life Balance: Flex My Way is a set of supportive workplace policies designed to help manage personal and professional responsibilities, whether caring for family, giving back to the community, or finding time to refresh and reset. This builds upon our flexible work arrangements, including work from anywhere for up to 8 weeks per year, empowering employees to achieve a better work-life balance. Career Development and Growth: By fostering a culture of continuous learning and skill development, we prepare our talent to tackle tomorrows challenges and deliver real-world solutions. Our Grow My Way programming and skills-first approach ensures you have the tools and knowledge to grow, lead, and thrive in an AI-enabled future. Industry Competitive Benefits We offer comprehensive benefit plans to include flexible vacation, two company-wide Mental Health Days off, access to the Headspace app, retirement savings, tuition reimbursement, employee incentive programs, and resources for mental, physical, and financial wellbeing. Culture: Globally recognized, award-winning reputation for inclusion and belonging, flexibility, work-life balance, and more. We live by our valuesObsess over our Customers, Compete to Win, Challenge (Y)our Thinking, Act Fast / Learn Fast, and Stronger Together. Social Impact Make an impact in your community with our Social Impact Institute. We offer employees two paid volunteer days off annually and opportunities to get involved with pro-bono consulting projects and Environmental, Social, and Governance (ESG) initiatives. Making a Real-World Impact: We are one of the few companies globally that helps its customers pursue justice, truth, and transparency. Together, with the professionals and institutions we serve, we help uphold the rule of law, turn the wheels of commerce, catch bad actors, report the facts, and provide trusted, unbiased information to people all over the world. Thomson Reuters informs the way forward by bringing together the trusted content and technology that people and organizations need to make the right decisions. We serve professionals across legal, tax, accounting, compliance, government, and media. Our products combine highly specialized software and insights to empower professionals with the data, intelligence, and solutions needed to make informed decisions, and to help institutions in their pursuit of justice, truth, and transparency. Reuters, part of Thomson Reuters, is a world leading provider of trusted journalism and news. We are powered by the talents of 26,000 employees across more than 70 countries, where everyone has a chance to contribute and grow professionally in flexible work environments. At a time when objectivity, accuracy, fairness, and transparency are under attack, we consider it our duty to pursue them. Sound excitingJoin us and help shape the industries that move society forward. As a global business, we rely on the unique backgrounds, perspectives, and experiences of all employees to deliver on our business goals. To ensure we can do that, we seek talented, qualified employees in all our operations around the world regardless of race, color, sex/gender, including pregnancy, gender identity and expression, national origin, religion, sexual orientation, disability, age, marital status, citizen status, veteran status, or any other protected classification under applicable law. Thomson Reuters is proud to be an Equal Employment Opportunity Employer providing a drug-free workplace. We also make reasonable accommodations for qualified individuals with disabilities and for sincerely held religious beliefs in accordance with applicable law. 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Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.

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 (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Preferred candidate profile from pharma Company ro worked for pharma on 3rd party for atleast 3 yrs Contact Interested candidates can share there updated cv at ankita@topgearconsulatnts.com

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Palantir Foundry Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Project Role :Lead Data Engineer Project Role Description :Design, build and enhance applications to meet business process and requirements in Palantir foundry.Work experience :Minimum 6 years Must have Skills :Palantir Foundry , PySpark, TypeScript (for customizing Workshop Forms & UI)Good to Have Skills :Experience in Pyspark, python and SQLKnowledge on Big Data tools & TechnologiesOrganizational and project management experience.Job & Key Responsibilities :Responsible for designing , developing, testing, and supporting data pipelines and applications on Palantir foundry.Configure and customize Workshop to design and implement workflows and ontologies.Configure and customize Workshop applications, including designing Forms, Workflows, and Ontology-based interactions.Write TypeScript to create dynamic and interactive Forms in Workshop for user-driven data entry and validation.Collaborate with data engineers and stakeholders to ensure successful deployment and operation of Palantir foundry applications.Work with stakeholders including the product owner, data, and design teams to assist with data-related technical issues and understand the requirements and design the data pipeline.Work independently, troubleshoot issues and optimize performance.Communicate design processes, ideas, and solutions clearly and effectively to team and client. Assist junior team members in improving efficiency and productivity. Technical Experience :Proficiency in PySpark, Python and Sql with demonstrable ability to write & optimize SQL and spark jobs.Hands on experience on Palantir foundry related services like Data Connection, Code repository, Contour , Data lineage & Health checks.Good to have working experience with workshop , ontology , slate.Hands-on experience in data engineering and building data pipelines (Code/No Code) for ELT/ETL data migration, data refinement and data quality checks on Palantir Foundry.Experience in TypeScript to create and customize Forms in Workshop, including form validation, user interactions, and data binding with Ontology.Experience in ingesting data from different external source systems using data connections and sync.Good Knowledge on Spark Architecture and hands on experience on performance tuning & code optimization.Proficient in managing both structured and unstructured data, with expertise in handling various file formats such as CSV, JSON, Parquet, and ORC.Experience in developing and managing scalable architecture & managing large data sets.Good understanding of data loading mechanism and adeptly implement strategies for capturing CDC.Nice to have test driven development and CI/CD workflows.Experience in version control software such as Git and working with major hosting services (e. g. Azure DevOps, GitHub, Bitbucket, Gitlab).Implementing code best practices involves adhering to guidelines that enhance code readability, maintainability, and overall quality. Educational Qualification:15 years of full-term education Qualification 15 years full time education

Req ID: 327022 We are currently seeking a SAP BTP to join our team in Bengaluru, Karntaka (IN-KA), India (IN). Day to Day job Duties Design and development of SAP integration solutions utilizing SAP BTP Integration Suite services. Collaborate with customers, cross-functional teams to gather business requirements and translate them into technical solutions. As an integration subject matter expert, create SAP BTP technical architecture, guide, mentor and develop integration best practices. Support pre-sales and practice led solution development activities. Coordinate with team members, customers, manage tasks, and deliverables, and anchor team development activities. Troubleshoot and resolve SAP BTP integrations issues in customer landscape. Basic Qualifications Must Have"s Minimum 3 years of experience with at least One large/complex end to end CPI development project and one support project exposure. Experience in developing inbound and outbound interfaces to/from the cloud to On-Premise and Cloud instances of SAP Products. Experience in configuration and extension of standard iFlows. Experience in defining custom iFlows, local & exception sub-processes, exception handling. Expertise in handling various integration adapters in SAP CPI (SFSF, ODATA, SFTP, IDOC, SOAP, HTTP, Process Direct, REST Adapters) to exchange messages between sender and receiver. Knowledge on developing value mapping and Groovy and using it in iFlows. Experience in handling different data conversions like JSON to XML, CSV to XML, etc. Experience in using various CPI options (integration patterns " message transformations, enricher, splitter, etc.) Experience in handling security artifacts, encryption, and decryption mechanisms and SSH keys. Good Understanding of Project methodologies and implementation lifecycle. Effective communication, organization and planning, work ethic, client-facing, and interpersonal skills. Education Bachelor's Degree or higher is preferred. Travel: This position requires limited or No travel. Nice to Have (but not a must) SAP BTP DevOps knowledge (CI/ CD, Jenkins, Pipeline Management). Hands on experience development full stack application on BTP using CAP and/or RAP frameworks. Hands-on experience in BTP Process Automation, RPA bot development.

About The Role SDET Rest Assure ? Experience with Selenium on automating web applications using Java. Experience with testing APIs using API testing tools such as Postman. Experience with Rest Assured and automating REST web services. Experience in Cucumber BDD framework for creating test cases. Experience with Github, Maven, TestNg and CICD integration tools like Bamboo. Experience in writing SQL queries and knowledge in accessing DB like Snowflake, Mongo DB. Programming skills in Java. Experience in Agile Scrum methodology Experience with bug and backlog management Experience with Test Case Management systems Experience with surfacing & executing on continuous improvement initiatives within quality teams Experience with ExtentReport, Apache POI, Open CSV, MSSQL-JDBC, Bitbucket, JavaXmail, and/or Exclipse/Intellij a bonus Experience with Jira is a bonus Experience with Pricing and/or in the wholesale food distribution industries is a bonus Experience with quality focused metrics and auditing systems of test is a bonus ? ? NoPerformance ParameterMeasure1Understanding the test requirements and test case design of the productEnsure error free testing solutions, minimum process exceptions, 100% SLA compliance, # of automation done using VB, macros2Execute test cases and reportingTesting efficiency & quality, On-Time Delivery, Troubleshoot queries within TAT, CSAT score ? Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Good knowledge and in Python, sql, Perl with 6+ years experience. Good problem solving skill. Ability to understand the data and its relations Capability to learn new technologies in short span of time. Should be able to work in Sprint and meet deadlines. Flexible Work time. Mandatory Skills: Python - Basics, Pandas, Web scrapping, File and XML Handling, Extracting/Manipulating -Excel/CSV/Any File Formats.Perl - Basics, CPAN modules, File and Web scrapping/Handling.** Work from option is available

Roles and Responsibilities: 4+ years of experience as a data developer using Python Knowledge in Spark, PySpark preferable but not mandatory Azure Cloud experience (preferred) Alternate Cloud experience is fine preferred experience in Azure platform including Azure data Lake, data Bricks, data Factory Working Knowledge on different file formats such as JSON, Parquet, CSV, etc. Familiarity with data encryption, data masking Database experience in SQL Server is preferable preferred experience in NoSQL databases like MongoDB Team player, reliable, self-motivated, and self-disciplined

The Data Integration Engineer will play a key role in designing, building, and maintaining data integrations between core business systems such as Salesforce and SAP and our enterprise data warehouse on Snowflake. This position is ideal for an early-career professional (1 to 4 years of experience) eager to contribute to transformative data integration initiatives and learn in a collaborative, fast-paced environment. Duties & Responsibilities: Collaborate with cross-functional teams to understand business requirements and translate them into data integration solutions. Develop and maintain ETL/ELT pipelines using modern tools like Informatica IDMC to connect source systems to Snowflake. Ensure data accuracy, consistency, and security in all integration workflows. Monitor, troubleshoot, and optimize data integration processes to meet performance and scalability goals. Support ongoing integration projects, including Salesforce and SAP data pipelines, while adhering to best practices in data governance. Document integration designs, workflows, and operational processes for effective knowledge sharing. Assist in implementing and improving data quality controls at the start of processes to ensure reliable outcomes. Stay informed about the latest developments in integration technologies and contribute to team learning and improvement. Qualifications: Required Skills and Experience: 5+ years of hands-on experience in data integration, ETL/ELT development, or data engineering. Proficiency in SQL and experience working with relational databases such as Snowflake, PostgreSQL, or SQL Server. Familiarity with data integration tools such as FiveTran, Informatica Intelligent Data Management Cloud (IDMC), or similar platforms. Basic understanding of cloud platforms like AWS, Azure, or GCP. Experience working with structured and unstructured data in varying formats (e.g., JSON, XML, CSV). Strong problem-solving skills and the ability to troubleshoot data integration issues effectively. Excellent verbal and written communication skills, with the ability to document technical solutions clearly. Preferred Skills and Experience: Exposure to integrating business systems such as Salesforce or SAP into data platforms. Knowledge of data warehousing concepts and hands-on experience with Snowflake. Familiarity with APIs, event-driven pipelines, and automation workflows. Understanding of data governance principles and data quality best practices. Education: Bachelors degree in Computer Science, Data Engineering, or a related field, or equivalent practical experience.

Experience:- 2+ Years. Location:- Electronic City, Bengaluru. Skills:- Authorising, Reviewing, Validation Documents Minimum Qualifications expected for the candidates • Degree in computer engineering / equivalent. with CSV especially in IT pharma enterprise systems • Strong communication skills • A comprehensive understanding of GxP, GAMP 5, Infrastructure Management, Computerized System Validation, (Initial Risk Assessment, Disaster Recovery Process, Data Security etc), and QMS. • Proficiency in project and stakeholder management

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.