116 Csv Jobs - Page 4

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation for pharma or medical devices and stakeholder management to join our EY-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 and 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 teamwork 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, EY 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 Management System - 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, Data Migration strategy and report 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, oral and presentation skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA), ISO 13485:2016 – Medical Devices – Quality Management System Information Security (ISO 27001) or Risk Management certifications What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you

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 Experience in Authoring all CSV deliverables

In Time Tec is an award-winning IT & software company. In Time Tec offers progressive software development services, enabling its clients to keep their brightest and most valuable talent focused on innovation. In Time Tec has a leadership team averaging 15 years in software/firmware R&D, and 20 years building onshore/offshore R&D teams. We are looking for rare talent to join us. People having a positive mindset and great organizational skills will be drawn to the position. Your capacity to take initiative and solve problems as they emerge, flexibility, and honesty, will be key factors for your success at In Time Tec. We are looking for a skilled Power Automate RPA Developer to design, develop, and maintain Robotic Process Automation (RPA) solutions using Power Automate Desktop (PAD) and Power Automate Cloud Flows. Key Responsibilities: Design, develop, and implement RPA solutions using Power Automate Desktop and Cloud Flows or UI Path or Automation anywhere. Automate business processes by integrating Dataverse, SharePoint, SQL Server, Office 365, SAP, ServiceNow, and other third-party applications. Develop and maintain attended and unattended RPA bots for process automation. Work with OCR, AI Builder, and document automation to extract and process structured/unstructured data. Implement error handling, logging, and exception handling in RPA workflows. Monitor, troubleshoot, and optimize bot performance and execution time. Ensure security best practices, compliance, and governance in Power Automate implementations. Required Skills & Experience: Good experience in developing RPA solutions using Power Automate Desktop (PAD) and Power Automate Cloud Flows. Strong understanding of Power Platform (Power Apps, Dataverse, Power BI, AI Builder). Experience with UI automation, web automation, desktop automation, and API-based automation. Proficiency in handling CSV, Excel, PDFs, and database interactions within RPA workflows. Knowledge of Microsoft Power Platform security, permissions, and DLP policies. Hands-on experience with REST APIs, JSON, and HTTP requests for integration. Strong debugging, problem-solving, and exception-handling skills. Preferred Certifications: Microsoft PL-500: Power Automate RPA Developer Microsoft PL-900: Power Platform Fundamentals Roles and Responsibilities

The Opportunity As an SAP CPI Developer, you will be responsible for designing, developing, and maintaining CPI programs and enhancements to support our clients' needs. You will also be expected to demonstrate strong technical proficiency in S/4 HANA implementations, contributing as part of an exceptional team to deliver high-quality solutions. Key Responsibilities The role will include but not be limited to: Experience in developing inbound and outbound interfaces to/from the cloud to On-Premises 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 iFlow. Experience in handling different data conversions like JSON to XML, CSV to XML, etc. Experience in using various CPI pallet options (integration patterns message transformations, enricher, splitter, etc.) and experience in SAP BTP Experience in handling security artifacts, encryption, and decryption mechanisms and SSH keys. Experience with EDI integrations, API management is a must. Understanding of EDI transactions like PO transmission and confirmation, ASN, Payment remittance advice, Product catalogs and Transportation and shipping status is a must. Experience with EDI standards ANSI X12, UN/EDIFACT is desirable. Desirable Experience on AMS projects and is aware of the Service processes of AMS Incident Mgt., Service Request Mgt., Problem Mgt., SLM. Knowledge of ABAP (Business Partner creation and maintenance, IDoc creation and maintenance and debugging) Your Experience First and foremost, you are a genuine Management Consultant with exceptional communication skills, the ability to see the bigger picture, and a collaborative approach to creating exceptional solutions. You will also have relevant SAP skills, including: 5+ years of experience in a full cycle implementation & integration in support projects. 2+ years of experience in designing, development, and implementation of integration flows (iFlows) using SAP CPI Looking for SAP CPI professional with hands-on experience on S/4 HANA implementation.

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance. - Provide on-site or remote assistance during testing and data collection phases. Documentation and Reporting: - Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports. - Create clear and organized documentation that demonstrates compliance and traceability. Change Control and Risk Management: - Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed. - Advise on the impact of changes and recommend appropriate validation strategies. Regulatory Compliance: - Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation. - Apply your expertise to guide clients in meeting regulatory requirements during the validation process. Client Collaboration: - Build strong working relationships with clients, acting as a trusted advisor and validation expert. - Provide guidance, recommendations, and regular updates to ensure successful validation outcomes. Training and Support: - Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles. Continuous Improvement: - Offer insights and suggestions for process improvement and optimization within the validation lifecycle. Required Qualifications and Candidate Profile: Diploma, Bachelors Degree or equivalent in technical area preferred 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems. Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation. Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.) Proven track record of delivering successful validation projects and ensuring compliance. Excellent communication and interpersonal skills to collaborate effectively with diverse clients. Candidate should be ready for travelling across India. Benefits: As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services. If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.

Description Key Responsibilities Analyse raw data from various source files (e.g. EXCEL CSV JSON XML Parquet etc.) to identify formatting issues inconsistencies missing values and discrepancies. Use PySpark to transform clean and restructure source data to match the expected format for further processing and analysis. Apply data validation rules and data quality checks to correct issues related to data integrity including handling null values duplicate records and data type mismatches. Develop PySpark jobs to transform raw data into standardized formats (e.g. converting date formats normalizing text fields correcting encoding issues). Ensure that data transformations meet the required schema and business logic by utilizing PySpark Data Frame and SQL functionalities. Automate data transformation workflows and schedule data correction jobs to handle repetitive tasks efficiently. Build interactive notebooks and workflows to perform data transformations and analytics within the Azure Data Bricks platform. Develop and maintain data workflows in Azure Data Factory to orchestrate data movement and transformation across cloud-based storage and compute services. Implement scheduled and event-driven data pipeline orchestration using ADF with focus on data quality performance and scalability. Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade C Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility Yes Global Role Family 60236 (P) Software Engineering Local Role Name 6504 Developer / Software Engineer Local Skills 35611 Azure Databricks Languages RequiredEnglish Role Rarity To Be Defined

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

Responsibilities: Manage preparation, review, and timely revision of SOPs, GTPs, and guidelines. Oversee DMS applications and ELN systems. Review and approve analytical protocols, reports (e.g., Method Validation, Verification, Regulatory Queries, Equivalency, PDR, MFC, AMT), and instrument qualifications. Conduct internal audits, lab monitoring, and ensure compliance with GDP and GLP standards. Provide training, review QMS documents (Incidents, Deviations, Change Control), verify electronic data, perform audit trail reviews, and assess Computer System Validation reports

Responsibilities: Develop, execute, and maintain validation protocols and documentation for PLC/SCADA systems and software. Ensure compliance with relevant regulatory standards, such as 21 CFR Part 11, GAMP 5, and ISO 13485. Conduct risk assessments and identify potential risks associated with PLC/SCADA systems and software. Develop and implement mitigation strategies for identified risks. Work with cross-functional teams to ensure that PLC/SCADA systems and software are designed, developed, and implemented in accordance with validation requirements. Provide technical expertise and support to project teams on validation-related matters. Stay up-to-date on the latest regulatory requirements and industry best practices. B.E/B. Tech/Diploma in Electrical / Electronics / IC.

Required Skills: • Resource with 2 -8 years of Relevant experience in Computerized System Validations of Enterprise applications (SAP/LIMS/TrackWise etc.), Equipment and Instrument validations (Manufacturing, Packaging, QC equipment/instruments and Serialization etc.). • Experience in Preparation and Execution of CSV deliverables (IQ, OQ and PQ). • Exposure in Assessment, Review and Preparation of 21 CFR part 11, EU annex 11 Compliance Assessment/Report. • Review of User, Error, Audit Trail records. • Skilled in Risk Assessment for Equipment/Instrument Operations. • Experience in Handling of QMS events (Change control, Deviation, RCI and CAPA). • Experience in Handling of end to end project CSV activities (is an added advantage). Technical Skills required: • Knowledge on handling of ValGenesis Application. • Hands on instrumentation, semi automation or automation • Worked on different layers of automation systems • Knowledge of IT- Operations, data and security management, backup & restore activities, • Exposure to maintenance, troubleshooting of GxP systems, • Understanding of technical & procedural risk assessment and actions. Soft skills (behavioral) required: Self-learner, Team player, Good Communication and Coordination with CFT etc. Any other specification / Requirement: • B. Tech, B.E. B.Sc. – Instrumentation /Electronics/ IT /B. Sc. (Computer Science) having knowledge of SAP, TrackWise, MES, BMS, EMS etc. • B. Pharmacy with exposure in regulation, analytical instrumentation, exposure to production activities along with exposure to latest software LIMS, HPLC etc. Experience Range: 2 to 8 years in Engineering, Consultancy, IT, CSV in Pharma domain

At UKG, you get more than just a job. You get to work with purpose. Our team of U Krewers are on a mission to inspire every organization to become a great place to work through our award-winning HR technology built for all. Here, we know that youre more than your work. Thats why our benefits help you thrive personally and professionally, from wellness programs and tuition reimbursement to U Choose a customizable expense reimbursement program that can be used for more than 200+ needs that best suit you and your family, from student loan repayment, to childcare, to pet insurance. Our inclusive culture, active and engaged employee resource groups, and caring leaders value every voice and support you in doing the best work of your career. If youre passionate about our purpose people then we cant wait to support whatever gives you purpose. Were united by purpose, inspired by you. Job Description: The Integration Consultant is responsible for creating solutions for various US-based clients to meet their interfacing requirements with UKG products in their environments. This includes generating different types of output files using XML/XSLT. The selected candidate will utilise the defined implementation process to achieve established milestones and targeted completion dates. They will work in Hybrid Mode to implement and support the UKG Ready Integrations and will collaborate closely with UKG Managers to complete tasks delegated by the Managers toward completing integrations. Key Responsibilities: Follow the Software Development Life Cycle (SDLC) process to provide solutions for interfaces. Understand client requirements and translate them into required integrations. Code, test, and deploy interfaces to meet customer needs. Work closely with UKG Managers to complete tasks related to integrations. Maintain flexibility to take calls in the evening with clients and US team members. Support major releases and upgrades during US hours when necessary. BE/ B Tech or Master's degree in Computer Science or a related field. At least 5+ years of industry experience. Must to have:- o Excellent oral and written communication skills. o Should be able to read an XML and follow the data flow as per the XML. o Should be able to co-relate between various types of files and their parsed XMLs; i.e. Fixed Width flat file to XML; CSV to XML; etc. o Should have a good understanding of the structure of an XML; i.e. Opening & Closing of Tags; Attributes, Nested Tags, and logical operations within Tags. o Should have good logical skills i.e. should be able to utilize pre-defined XML functions for making a logical operation. E.g. Switch Cases; Filters, etc. o Should have a basic understanding of nested FOR loops, this will be used in daily XML operations. Good to have:- o Experience in creating interfaces using tools/languages. o Domain knowledge of Human Capital Management (HCM) and Workforce Management (WFM). o Experience in designing, building, testing, deploying, and scheduling the integration process involving third-party systems. o Knowledge of REST API, and SOAP framework. o Strong customer interfacing skills.

Job Details : Organisation: Zydus Group Website: zyduslife.com About Us: Zydus is a global healthcare leader dedicated to innovation. We discover, manufacture, and market a wide range of healthcare therapies. With over 27,000 employees worldwide, including 1,400+ scientists, we are committed to creating healthier communities globally. Position: CSV - IT Location: Goa & Ahmedabad Qualification: BCA / MCA /B.E Experience: 3+ years Key Responsibilities: Administer user management activities as per SOP. Manage user access (activation, reset, change, deactivation) 24/7. Review, configure, and manage Privilege Right Matrix. Create and update User Access Matrix. Provide and review access for service engineers. Update application-wise process steps for user management. Prepare and implement site SOPs, ensuring periodic updates. Review qualification protocols and participate in instrument/software qualification activities. Handle IT-related QMS activities (change control, deviation, CAPA, incidents, qualification documents, SOPs). Manage backup and restoration activities. Support software assessments, maintenance, and network issues. Ensure compliance during periodic reviews. Verify GLP and desktop policies periodically. Conduct risk-based network failure tests. Communicate IT roles to auditors and regulators. Engage with middle/senior management. Lead and manage a team effectively.

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 7-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Participate in budget preparation, tracking, and control of capex. Manage end-to-end Instrumentation Package work (From Conceptualization till Commissioning). Managing contracts to ensure compliance from selection through closure. Create, update, and ensure adherence to engineering standards, including specifications for the procurement of instrumentation items, design calculations, bill of materials (BoMs), and other technical documentation Utilize software including TIA Portal, and Simatic Manager effectively. Knowledge and Know- how to PLC, Control valves & field Instrumentation, Plant Automation. Exposure to SCADA and ladder logics of small instruments. Exposure to various field instruments and programming. Coordinate and liaise with the purchasing department and suppliers for efficient procurement of Instrumentation Package Knowledge of GAMP, 21CFR Part 11/ cGMP regulatory requirements, CSV and GEP Engineering Practices. Must have knowledge of Facility requirement from US FDA and UKMHRA.

Job Description: We are looking for an experienced IT Quality Assurance (ITQA) Lead to join our team in a regulated pharmaceutical environment. The ideal candidate will have strong expertise in IT quality frameworks, computer system validation (CSV), and digital automation within reputed pharmaceutical companies. Key Responsibilities: Lead qualification and validation of various applications such as DMS, QMS, LMS, LIMS, etc. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 , and other relevant regulations. Develop and review Standard Operating Procedures (SOPs) and policies related to CSV. Conduct IT risk assessments and implement best practices for data integrity . Support internal and external audits (FDA, EU, WHO, TGA, etc.) for IT system compliance. Train and mentor IT and QA teams on GxP-compliant system validation . Requirements: 15-18 years of experience in ITQA/Digital Automation within a pharmaceutical company. Strong knowledge of IT quality frameworks and compliance regulations . Hands-on experience in computer system validation (CSV) . Expertise in managing IT audits and regulatory inspections . Excellent leadership and communication skills.

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. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Financial Data Management This includes managing accounts receivable, accounts payable, general ledger, and payroll data. Reporting and Analysis. Budgeting and Forecasting. Process Optimization. Compliance and Controls. Integration and Customization: Required Candidate profile A degree in finance, accounting, information systems, etc. A CPA/ CMA certification is preferred. 4+ yrs of exp in financial analysis, accounting, experience in using NetSuite or similar ERP systems.

Role & responsibilities 7-15 years experience IT CSV experience and not testers Validation of cloud systems Agile experience Vendor assessment experience Preferred candidate profile Perks and benefits

Primary Skills An IIB (IBM Integration Bus) Developer and Administrator is responsible for the design, development, configuration, and administration of IBM Integration Bus (now known as IBM App Connect ). The role involves creating and maintaining integration solutions, ensuring reliable communication between various systems, and managing the performance and security of the integration infrastructure. Secondary Skills 4+ years of experience in IIB development and administration . Strong understanding of IBM Integration Bus (IIB) , IBM App Connect , and integration concepts. Hands-on experience in developing message flows , web services , and data transformations using IIB. Solid experience with IBM MQ , including configuration, administration, and troubleshooting. Strong knowledge of enterprise integration patterns , middleware technologies , and data formats (XML, JSON, CSV). Proficiency in Java or other programming languages for extending IIB functionality. Skills (competencies) Critical Thinking Problem Solving Time Management Verbal Communication Written Communication

Hi, We are having an opening for Manager- Quality Informatics in our IT department at Halol location. Job Summary : Quality Control GxP Systems - Chromatographic & Non chromatographic systems, Data backup, User management, system software trouble shoot (L1), Computer system validation, Regulatory & Customer audits and compliance, QMS related IT (like Change control, Deviation, Investigation) etc. Areas Of Responsibility : Perform in-house software validation, re-validation of computerized systems of QC Lab and Micro area. Initiate and prepare active user list for Laboratory systems & Perform periodic access right and security policy review for Laboratory systems. Implementation of security policies as per site and global procedure. Perform administration activities as per procedure for computerized systems and instruments. Preparation of data backup and restoration procedures. Execution of manual backup and restoration in lab applications as per procedure. Coordinate with Corporate QA IT and QA department for implementation of Global Procedure. Prepare the SOP/CSAP for Lab computerized systems. Updation of roles and privileges as per business owner requirements and to perform validation related activity. Support Infra-IT activities. Authorized to review/ Signoff the documents related to the Quality informatics systems. Knowledge of Empower, Chromeleon, LABX, ICDAS, Lab Solutions. To perform QMS related activity. Educational Qualification : Diploma IT, BE IT, Computer Science Experience : 12 + Years

Product Validation ~Documentation Control ~Equipment Validation & Qualification ~Product Lifecycle Management ~Defect Management ~Project Handling Expertise Knowledge of FDA regulations, EU guidelines, CSV, GAMP guidelines and product development process. Ensuring the quality compliance with respective areas and GxP guidelines. Significant exposure in maintaining & ensuring stringent adherence to quality, identifying gaps, norms & practices. Abilities to understand their requirement related to product they need and deliverables. Abilities in implementing quality plans with focus on identifying gaps. Key result Areas: Execution and compliation of CSV Qualifications for all the GxP applications in Manufacturing area. Execution of Qualification activities IQ, OQ, PQ for all GxP systems in the manufacturing process equipments. Administration and User Management of all the laboratory applications, Instruments, Manufacturing process Equipments as per SOP. Vendor co-ordination for all the IT related news projects and requirements. Co-ordination with CFT's for qualification document approvals. Performing the User ID Role Matrix, Manual Backup periodic activity as per SOP. Ensuring that validation activities align with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and other applicable guidelines. Ensuring all documentation aligns with regulatory expectations and internal quality standards. Responsible for curation and review of quality and validation documents with assurance of GxP compliance, adherence to safety polices. Responsible for knowledge sharing to new joiners on projects and standard operating procedure. Responsible for putting ideas and suggestions to teams with respect to process & projects.

Job Title: Google Ads and Merchant Center Specialist Location: Bengaluru, India (Full-Time, Ofiice) Key Responsibilities: Manage and optimize Google Ads campaigns to maximize ROI and achieve business objectives. Upload and manage product feeds in Google Merchant Center using XML and API integrations. Resolve Google Merchant Center policy violations and errors effectively. Update and maintain content on our WordPress site to ensure accuracy and relevance. Collaborate with the marketing team to develop and implement advertising strategies. Analyze performance data to provide actionable insights and recommendations for improvement. Requirements: Proven experience with Google Ads and Google Merchant Center. Strong understanding of XML and API processes for product feed management. Ability to troubleshoot and resolve issues related to Google Merchant Center policies. Proficiency in WordPress for content updates and management. Excellent analytical skills with a data-driven approach to problem-solving. Strong communication and teamwork skills. What We Offer: Competitive salary and benefits package. Opportunity to work with a dynamic and innovative team. Professional development and growth opportunities.

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolioof biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, severalwith Sandoz and is developing many independently. BioconBiologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Job Level: Associate Manager - IT quality and Compliance Location: Bengaluru (Jigani Link Road) Job Type: Full-Time Experience Required: 5-6 years in Life Sciences with 3-4 years in IT Job Description: Ideal candidate will have a strong background in the life sciences domain, with hands-on experience in the validation of scientific applications such as Laboratory Information Management Systems (LIMS) and other laboratory instruments Key Responsibilities: Lead and manage the validation processes for scientific applications, ensuring compliance with industry standards and regulations. Collaborate with cross-functional teams to implement and maintain LIMS and other scientific applications. Provide technical expertise and support for the integration and optimization of scientific applications. Develop and execute validation protocols, test plans, and reports. Ensure data integrity and security within scientific applications. Troubleshoot and resolve issues related to scientific applications and their interfaces. Stay updated with the latest trends and advancements in life sciences and IT. Qualifications: Bachelor’s or master’s degree in Life Sciences, Biotechnology, Bioinformatics, or a related field. Overall experience of 9+ years of employment tenure. 5-6 years of experience in the life sciences domain. 3-4 years of experience in IT, specifically in the validation of scientific applications. Strong knowledge of LIMS and other scientific applications. Excellent problem-solving and analytical skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Preferred Skills: Experience with regulatory compliance (e.g., FDA, EMA). Knowledge of GxP, 21 CFR Part 11, and other relevant regulations. Familiarity with project management methodologies. Review operations and related controls provide assistance to Author applicable SOPs governing the CSV processes for BBL IT Equal Opportunity Employer Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.

The Consultant is responsible for creating solutions for different US based clients to meet their interfacing requirements with UKG products in their environment. The interfacing requirements could be creating different kind of output files using Dell Boomi. The Consultant should have in-depth knowledge of the WFM concepts and some knowledge of related tools which will assist in creating these customized solutions. The successful candidate will utilize the defined implementation process to meet the established implementation milestones and targeted completion dates. They will work remotely to implement and support the UKG Dimensions Implementation and will work closely with the UKG Project Managers to complete tasks delegated by the Project Managers toward completing system implementations. Other responsibilities will include the following customer related tasks: • Using Professional Services concepts, implement software in various environments • Follow the SDLC process to provide the solution for Interfaces • Understanding the requirements from the client • Preparing the design document • Coding, testing and deploying the interfaces • User Acceptance Testing support • Coding, testing and deploying the interfaces • Deploy and release to production environment • Final hand off to global support • Upgrading existing UKG customers from lower versions to a more compatible and recent version. This will include porting of the full-suite UKG implementation and delivering it as a like to like solution. Overall, understanding of the UKG solution is a must for successfully upgrading and deploying the solution The Consultant should show the flexibility for taking calls in the evening with the client and the US team members. In certain scenarios, they will be required to support major releases and upgrades during US hours. Qualification Bachelors degree or equivalent in Computer Science or related field At least 2-5 years of industry experience Experience in creating interfaces for upstream/downstream using Dell Boomi Domain knowledge of HCM/WFM is an additional advantage Involved in design, build, test, deploy and scheduling the Integration process involving third party systems Designed and developed integration using Boomi AtomSphere integration platform or similar Integration Tools Experience in Dell Boomi components, connectors, Application Source Qualifier, Mapping Designer and Transformations would be good to have Knowledge on Rest API, SOAP framework, XML, Web service design would be good to have Excellent oral and written communication skills Good customer interfacing skills