116 Csv Jobs - Page 2

Job location - Hyderabad Job title - Sr. Network Engineer PC & IS Network engineer Job description - Education and Experience: B.Tech in IT/Electrical Engineering with at least 5 years of experience . Experience working in P&G preferred. Skills Required: Controls & PC&IS: 1. Logic and programming in Allan Bradley PLC 2. Logic and programming in Mitsubishi PLC 3. Communication setup across HDL line PLCs and vision system Network: 1. Defining network architecture (AED/TID) 2. Execution and implementation of network architecture 3. Completing iRisk and CSV for applications 4. Switch and port configuration and enabling firewall rules, configuring ping integrations on applications 5. Establishing communication between OT/IT layers Admin & communication: 1. Coordinating with Europe and US teams 2. Incorporating inputs, creating documentation, and sharing MoM

**Job Summary** The CSV Specialist will lead and support Computer System Validation (CSV) activities, specifically for computerized systems used in the development and manufacture plantswithin a pharmaceutical environment. This role requires a deep understanding of CSV regulations, quality standards, and an ability to ensure compliance with both FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements. 1. **Validation Planning and Execution** - Lead and manage CSV projects for new and existing computerized systems, ensuring adherence to CSV lifecycle processes and compliance with regulatory standards. - Develop and maintain validation documentation, including validation plans, protocols, summary reports, and risk assessments. - Conduct system risk assessments, functional and technical assessments, and determine validation strategy. 2. **Regulatory Compliance* -Ensure compliance with FDA, EU, and global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . **Project Management** - Collaborate cross-functionally with IT, Quality, Manufacturing, and R&D teams to manage and execute validation projects, including system upgrades, migrations, and implementation of new computerized systems. - Develop and maintain project timelines and resource allocation, ensuring timely completion of validation activities. 4. **Documentation and SOP Development** - Author, review, and approve Standard Operating Procedures (SOPs), Work Instructions, and other CSV documentation. - Maintain and update documentation for validation activities, ensuring alignment with Good Documentation Practices (GDP). 5. **Training and Support** - Train and mentor team members on CSV processes, regulatory requirements, and best practices for maintaining validated systems. - Provide technical support during audits and inspections by regulatory authorities and internal quality audits. 6. **Continuous Improvement** - Identify and implement process improvements to enhance efficiency, compliance, and reliability of computerized systems. - Develop risk mitigation strategies and contribute to overall process excellence in CSV practices. ### **Qualifications** - **Education**: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degree preferred. - **Experience**: 10-15 years of relevant experience in CSV within the pharmaceutical and/or medical device industry. - **Technical Skills**: - Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other regulatory standards. - Proficient in validation protocols, testing methodologies, and risk management principles. - Familiarity with IT infrastructure, software development lifecycle (SDLC), and Quality Management Systems (QMS). - **Soft Skills**: Excellent communication and interpersonal skills, with the ability to manage multiple stakeholders and work effectively in cross-functional teams. - **Certifications**: Preferred certifications include Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent CSV-related certifications. ### **Other Requirements** - Ability to work in a highly regulated environment and under strict quality and regulatory guidelines. - Strong analytical and problem-solving skills, with a focus on compliance and risk-based validation. - Willingness to travel for audits, training, and support, as required.

Role & responsibilities: Strong experience in catalog management and product data maintenance. Proficiency in tools such as Excel, CSV imports, and catalog management . Familiarity with bulk uploads, product listing, and maintaining product specifications and descriptions. Experience working in a fast-paced, deadline-driven environment.

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

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. 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)

Role & responsibilities Monitoring Backup jobs training the documentation, and keeping to IT Head approval. Responsible for tracking hardware and software inventory in the ticketing tool. Updating the IT assets Maintaining the labels for all IT assets. Responsible for the Backup Responsible for GMP-related queries and prepared the documentation IT-related bills are filed and kept for approval. PCB-related onsite support and coordinating with vendors supported by the reporting Head. Monitoring and maintaining the CC Cameras infrastructure and escalating to the head if anything is critical. Troubleshooting third-party applications at the Unit level and escalating to the reporting Head to get solutions from 3rd party vendors. Technical Support on Enterprise resource planning (ERP/FOCUS) to End users through (Ticket, Mail, Mobile, and Remote) in Sipra has the following modules: Accounts, Purchase, Sales, Inventory, and Payroll. Conduct training sessions for new and existing users for any developments supported by the IT Head. Knowledge on complete Desktop and Server support. Configuring servers using 2003, 2008,2012, 2016 and 2019. Knowledge on Active Directory services, Installing active directory-Domain controller, group policies and adding Client machines in to AD User administration i.e., setting up user accounts, permissions and passwords Knowledge on remote technical assistance Software installations and configurations. Establishing LAN, adding / removing nodes to / from LAN Working knowledge of MS Active Directory 2012 and 2016 Knowledge on DNS, DHCP & FTP Knowledge on firewalls, routers and switches(Cisco, WatchGuard) Giving complete technical support to all virus-related issues and network related issues Managing email, anti-spam and virus protection. Preferred candidate profile Pharma Experience is must for the candidate. Should have basic understanding for 21CFR and GXP Systems

API -QA

Shift: Night Shift Mandatory skills: 6+ yrs C# Development, .Net Framework, ASP.Net API Responsibilities: - Develop, test, and deploy high-quality C# applications (Console and Web). - Design and manage MS-SQL databases with complex queries and procedures. - Handle data transformations using JSON, XML, and CSV. - Build and maintain ASP.NET Core APIs for internal/external use. - Integrate and consume external APIs. - Conduct code reviews and ensure best practices. - Collaborate with cross-functional remote teams. - Troubleshoot technical issues promptly. - Contribute to process improvements and stay current with tech trends. Qualifications: - 6+ years of C# development experience. - Strong knowledge of .NET framework and MS-SQL Server. - Experience with JSON, XML, CSV data handling. - Proficient in ASP.NET Core API development. - Strong problem-solving and communication skills. - Comfortable working independently in a remote setup. com

So, whats the job? You'll lead the design, development, and optimization of scalable, maintainable, and high-performance ETL/ELT pipelines using Informatica IDMC CDI. You'll manage and optimize cloud-based storage environments, including AWS S3 buckets. You'll implement robust data integration solutions that ingest, cleanse, transform, and deliver structured and semi-structured data from diverse sources to downstream systems and data warehouses. You'll support data integration from source systems, ensuring data quality and completeness. You'll automate data loading and transformation processes using tools such as Python, SQL, and orchestration frameworks. You'll contribute to the strategic transition toward cloud-native data platforms (e.g., AWS S3, Snowflake) by designing hybrid or fully cloud-based data solutions. You'll collaborate with Data Architects to align data models and structures with enterprise standards. You'll maintain clear documentation of data pipelines, processes, and technical standards, and mentor team members in best practices and tool usage. You'll implement and enforce data security, access controls, and compliance measures in line with organizational policies. And what are we looking for? You'll have a Bachelors degree in Computer Science, Engineering, or a related field with a minimum of 5 years of industry experience. You'll be an expert in designing, developing, and optimizing ETL/ELT pipelines using Informatica IDMC Cloud Data Integration (CDI). You'll bring strong experience with data ingestion, transformation, and delivery across diverse data sources and targets. You'll have a deep understanding of data integration patterns, orchestration strategies, and data pipeline lifecycle management. You'll be proficient in implementing incremental loads, CDC (Change Data Capture), and data synchronization. You'll bring strong experience with SQL Server, including performance tuning, stored procedures, and indexing strategies. You'll possess a solid understanding of data modeling, data warehousing concepts (star/snowflake schema), and dimensional modeling. You'll have experience integrating with cloud data warehouses such as Snowflake. You'll be familiar with cloud storage and compute platforms such as AWS S3, EC2, Lambda, Glue, and RDS. You'll design and implement cloud-native data architectures using modern tools and best practices. You'll have exposure to data migration and hybrid architecture design (on-prem to cloud). You'll be experienced with Informatica Intelligent Cloud Services (IICS), especially IDMC CDI. You'll have strong proficiency in SQL, T-SQL, and scripting languages like Python or Shell. You'll have experience with workflow orchestration tools like Apache Airflow, Informatica task flows, or Control-M. You'll be knowledgeable in API integration, REST/SOAP, and file-based data exchange (e.g., SFTP, CSV, Parquet). You'll implement data validation, error handling, and data quality frameworks. You'll have an understanding of data lineage, metadata management, and governance best practices. You'll set up monitoring, logging, and alerting for ETL processes.

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.

Werum PAS-X Support Engineer Experience Level: 6-9 Onsite: Bangalore Roles & Responsibilities: System management/Support ITIL, System/Application management experience, CSV knowledge Skill Area: MES Background (Pas-X knowledge preferred) , ITIL, System/Application management experience, CSV knowledge Main Technology: MES/Pas-X Mandatory Skills: (Must Have Skills) Pas-X

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VALIDATION is MUST, preferably in Life Science . EXP in process optimization in automated test environment. GOOD knowledge in software development life cycle ( SDLC ). EXP in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guideline and FDA regulations on COMPUTER SYSTEM VALIDATION . Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICH and FDA. Coordinating multiple validation and qualification activities with project teams, various departments and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments. Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11 to client personnel. Representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/https://g.co/kgs/UAsF9W

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge on Computer system Assurance (CSA) Experience in the validation of software and tools in a FDA regulated environment. (e.g, SAP, Solution Manager, EDMS, LIMS, PLC/SCADA systems etc.) Good to have experience on infrastructure qualification documentation- QP, IS, IQ, RTM Basic understanding of cyber security, Public Cloud Platforms such as AWS, Azure, IT Network components is a plus point. Experience of authoring and reviewing validation documentation and SOPs to maintain compliance Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies as per cGxP Experience in risk assessment during the implementation and operation of IT solutions. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and SOPs. Review the accuracy and completeness of software validation deliverables created by other process teams CSV deliverables like of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like SOPs, Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols for accuracy, consistency, clarity, and completeness Understand Deviation, how to perform its investigation and propose CAPA for the deviation. Handled change management and aware of writing change requests. Experienced in working with validation tools such as HP ALM/Validator/Valgenesis Ability to lead projects end-to-end, including stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible. Experience in facing internal quality audits, vendor audits and also providing support during audits by external auditors like US FDA in validation perspective. Mandatory Skills 21 CFR part 11, EU Annex 11, GAMP MS Office Suite- Word, Excel, PowerPoint Good verbal, and written communication skills in English Good to have Knowledge of 21 CFR Part 210, 211, 820, EU MDR, SOX, CSA Certifications such as ISO 27001, Cloud certification, Testing ISTQB, TMMi Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.

Hi, We are having an opening for R&D-IT Manager-ELN at our Baroda location. Job Summary : R&D-IT Manager will be responsible for the successful implementation of assigned projects. This role requires a strong technical skills and deep compliance understanding of R&D and Lab procedures and processes and the ability to work closely with cross-functional teams to ensure IT applications are running successfully. Experience in ELN implementation is preferred. Role and Responsibilities : ELN implementation for R&D Functions NuGenesis SDMS platform upgrade implementation Implementation of PMS- Store Inventory & Equipment inventory Computer System Validation of scientific software and instrument software Managing and closure of assigned QMS within the timelines Application support for Regulatory information management project Implementation support, testing and documentation of ongoing projects at R&D Baroda site Responsible to face internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably Pharma/ life sciences domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications Familiarity with laboratory instruments and software ELN implementation experience Good documentation skills to create and manage GxP documents Project Management skills

Hi, We are having an opening for Executive/Sr. Executive- R&D IT at our Gurgaon location Job Summary : R&D-IT Executive/Sr. Executive will be responsible for supporting IT applications, managing QMS across R&D Gurgaon functions. The person should have a strong understanding of CSV. The role requires a good understanding and experience in R&D/Lab policies and procedures to ensure applications/QMS are comply as per the applicable regulation. Job Description : Role and Responsibilities Application support for R&D applications (PMS, NuGenesis, Empower, Amplexor etc.) Managing and closure of assigned QMS within the timelines Application implementation support, testing and documentation of ongoing assigned projects Helping and providing IT support to business users during Performance Qualification phase Perform miscellaneous job-related duties as assigned Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 3-5 years of experience in application support, preferably Pharma/ life sciences domain Strong understanding of CSV Software Development Life Cycle Preferred Qualifications Experience in NuGenesis and Empower is preferred Good documentation skills to create and manage GxP documents

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.) Experience in ensuring the compliance of GxP application validation and Infrastructure Qualification Successful cross-divisional/functional work with complex international teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, interpersonal skills, and critical thinking COMPANY : SANDOZ LOCATION : HYDERABAD CONTRACT FOR 6 MONTHS WILL BE RENEWED ON PERFORMNCE SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN

Company Description Welcome to AmpleLogic! We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. We are seeking a highly skilled and detail-oriented Quality Assurance (QA) Specialist with extensive experience in Computer System Validation (CSV) to join our team. This role will focus on ensuring the highest level of compliance, quality, and performance for all software and systems used within our organization, especially those that are regulated under industry standards. The ideal candidate will have a deep understanding of CSV processes, as well as experience working in highly regulated environments like pharmaceuticals, healthcare, or manufacturing. Oversee and execute Computer System Validation (CSV) for software and hardware systems, ensuring compliance with GxP, 21 CFR Part 11, FDA guidelines, and industry standards. Develop, review, and approve essential validation documents such as Validation Plans, URS, FRS, DS, and other relevant documentation. Create, execute, and document IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) test protocols to ensure systems meet required specifications. Ensure all validation processes align with regulatory requirements and industry best practices, maintaining up-to-date software compliance. Assist in both internal and external audits, regulatory inspections, and assessments, ensuring systems meet all compliance and quality standards. Perform risk assessments to determine validation needs and ensure thorough coverage during validation activities. Participate in change control processes to ensure validated systems remain compliant following updates or changes. Work with IT, Development, and Regulatory teams to ensure project requirements are met and provide internal training on CSV and SDLC practices. Monitor the quality of the final product, ensure compliance, control code release mechanisms, and manage action items from exited employees. Review processes, suggest improvements, maintain project documentation, perform audits, and handle LMS and software support tasks efficiently.

locationsIN - Bangalore posted onPosted 10 Days Ago time left to applyEnd DateMay 30, 2025 (13 days left to apply) job requisition idR139071 A.P. Moller - Maersk is an integrated container logistics company and member of the A.P. MollerGroup. Connecting and simplifying trade to help our customers grow and thrive. With a dedicatedteam of over 80,000, operating in 130 countries; we go all the way to enable global trade for a growingworld. From the farm to your refrigerator, or the factory to your wardrobe, A.P. Moller - Maersk isdeveloping solutions that meet customer needs from one end of the supply chain to the other. Team / Opportunity At Maersk, we are transforming to become the global integrator of container logistics- connecting and simplifying our customers supply chains. The Technology Group is critical to realising the company strategy. We plan on significantly enhancing our Technology capabilities and are implementing a new technology architecture led through Platform Operating Model. The Cloud Engineering Unit within the Technology Group is accountable for end to end delivery of Service Reliability, Availability, Performance, Cost and Fit for Purpose solutions there by enabling the Platform Operating Model. Who we are looking for 5+ years of Cargowise support engineer's responsibilities include: Bachelors/masters degree in computer science, Information Technology, or Engineering Providing second and third line support to users of the CW1 service desk Investigating support service level deviations and performing proactive troubleshooting Leading CW1 deployments and in-country engagements, including new country implementations Troubleshooting existing customizations workflow, tag rules files received via eAdaptor Demonstratable technical knowledge and expertise of CargoWise Cargowise One Workflow Design and understanding the use of event code, milestones, tasks and trigger and macro setup in filtering Experience using, configuring, and troubleshooting modules such as Registry, EDI Message, Tag Rules, Workflow Templates, and Buffer Management System Proficiency in handling data formats such as XML, JSON, EDIFACT, X12, raw text files, EXCEL, CSV, and tagged separated files XUE and XUS analysis and understanding of EDI communications setup with carriers, airlines and message analysis Experience in SNOW and handling of tickets before (preferred but not required) Producing comprehensive supporting documentation Collaborating with onshore and offshore teams to ensure quality transitions and develop functional specifications Proactively learning and sharing upcoming CW1 features Identifying continuous improvement opportunities Maersk is committed to a diverse and inclusive workplace, and we embrace different styles of thinking. Maersk is an equal opportunities employer and welcomes applicants without regard to race, colour, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, pregnancy or parental leave, veteran status, gender identity, genetic information, or any other characteristic protected by applicable law. We will consider qualified applicants with criminal histories in a manner consistent with all legal requirements. We are happy to support your need for any adjustments during the application and hiring process. If you need special assistance or an accommodation to use our website, apply for a position, or to perform a job, please contact us by emailing .

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

We at Smart Infrastructure Division in Siemens Ltd. is one of the top tier global suppliers of products, systems, solutions, and services for the efficient, reliable, and intelligent transmission and distribution of electrical power. As the trusted partner for the development and extension of an efficient and reliable power infrastructure that industry and the portfolio they need. JOIN US! WE MAKE REAL WHAT MATTERS. THIS IS YOUR ROLE. System Designing and Application Engineering for MV AIS panels (Domestic + Exports). Main responsibilities: Technical review of order inputs received from sales Creation complete engineering drawings including GA, SLD, schematic drawings etc Getting drawing approval from customer including attending customers / consultant meetings for approval. Co-ordinating with order manger, DTO (mechanical design team), logistics, drafting vendor etc. Candidate should possess: Good knowledge about Medium voltage power distribution system and AIS panels Knowledge of IS/IEC standards applicable for MV systems Hands on Experience/knowledge in AutoCADD, ELCAD, Promis, E Base tools Knowledge of Protection Philosophy Expert in control philosophy of substation Good Communication skill Capable to interact independently with client for technical discussions Experience in handling major Engineering consultant like EIL, TCE, AECOM, Toyo, Mecon, Fitchtner, TKIS etc Education: B.E. / Diploma in Electrical Engineering with minimum 4 to 5 Years of Experience WE"™VE GOT QUITE A LOT TO OFFER, HOW ABOUT YOU? We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we encourage applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit, and business need. Bring your curiosity and creativity and help us shape tomorrow.

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 are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines 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 execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved 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 data engineering teams to drive validation activities and meet project deadlines. ? Track 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. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience 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: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams 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 accommodation.

All Levels Comms & Media Non-Networks Join our team in Strategy consulting to find endless opportunities and solve our clients toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Comms & Media, Industry Consulting, S&C Global Network (GN) I Areas of Work: Non-Networks | Level: Manager & Sr Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Years of Exp: 8- 15 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, is the right place for you to explore limitless possibilities. Comms & Media (C&M) is one of the Industry Practices within Accenture's S&C Global Network (GN) team. It focuses in serving clients across specific Industries Communications, Media & Entertainment. Communications Focuses primarily on industries related with telecommunications and information & communication technology (ICT). This dynamic team serves most of the world's leading wireline, wireless, cable and satellite communications and service providers. Media & Entertainment Focuses on industries like broadcast, entertainment, print and publishing.Globally, works to develop value growth strategies for its clients, who are top-notch organizations, and help improve their offers and go-to-market performance and maximize organizational effectiveness. We work on end-to-end projects delivering management and technology consultancy to help our clients achieve greater profitability, quality, and reliability.From multi-year major systems integration transformation deals to shorter more agile engagements, we have a rapidly expanding portfolio of hyper-growth clients and an increasing footprint with next-gen technology and industry practices, with the following requirements: Deep expertise in one or more Telecom Domains Lead delivery of small to medium-size teams to deliver management consulting projects for global clients. Lead innovation transformation programs and process enablement for our clients Take responsibility within Comms & Media industry group or across the Products group, help build the practice, track metrics, and so on. Develop assets and methodologies , point-of-view, research, or white papers for use by the team and larger community. Support global sales team to identify and win potential opportunities within the practice. Help in drafting proposals as an expert for domain areas. Lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Understand customer needs and translate them to business requirements, business process flows and functional requirements Experience to engage with stakeholders independently Execute a transformational change plan aligned with client's business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Bring your best skills forward to excel in the role: Skills in one or more Telecom areas Should have an excellent knowledge on various BSS modules and Telco Journeys such as CRM, Order Management, Billing, Mediation, Provisioning, Collections, Channels, Customer Care, Lead to Cash etc. Digital Transformation - Proven experience in Strategy, Innovation and Digital initiatives across Digital Maturity models, CSPs Operating model, Innovation Barometers, Intelligent operations for CSPs and other related areas Cloud BSS - Determine the appropriate Cloud deployment model & design BSS journey to cloud strategies engineered to accelerate ROI and performance. Good to have knowledge of tools like AWS, Azure, SFDC, etc. Business Strategy - Leading/managing strategic initiatives and develop project plans, frame and conduct insightful analyses, identify solutions, and develop business cases and implementation plans for CSPs across the globe Transformation & Project Governance - Drive profitability and continued success though managing service quality, cost and leadership of the people delivering services across projects/ programs/portfolios of all scale Should have understanding of lean concepts and hands-on experience in delivering technology-driven business transformation projects using agile practices such as Scrum, Kanban, SAFe, etc. Experience in agile related tools like JIRA Confluence/Rally/MS Projects/VersionOne Certification profession in PSM/CSM/SAFe/ICP-ACC Skills in one or more roles Experience in the role of Functional Business Analyst, Product Owners, Process Designers, Service Designers, Scrum Masters, Program Delivery Managers Business Analysis - Gather requirements from business and prepared requirement documents. Propose solutions to the client based on gap analysis for the existing Telco platforms. Analyse large data to conduct analysis and present insights with visualisations Process Improvement - Understand issues with the current processes which can be resolved either through technology or process solutions and design detail level to-be process with all stakeholders Value Architect and Tracking - Create value driver trees to breakdown into value components of business objectives and value drivers Other required skills Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Impeccable team management skills with an ability to engage effectively with multiple stakeholders Strong program management skills Cross-cultural competence with an ability to thrive in a dynamic environment Qualifications Your experience counts! MBA from a Tier 1 and Tier 2 school and Engineering from Tier 1 school or rich relevant industry experience At least 1-15 years of progressive business and/or telecom and consulting experience Knowledge of Telco BSS/OSS stack, its various components, and interactions / flows Strong telecom industry background experience and knowledge of BSS processes for B2C and B2B areas Knowledge of telecom products across wireline, wireless and Enterprise domains eTOM certification is highly desirable Direct onsite experience (i.e., experience of facing client inside client offices in India or abroad) is mandatory. Please note we are looking for client facing soft skills Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management, telecom technology etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau Certifications like CBAP, CSM, SPC, Prince 2 or PMP will be an added advantage For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you? An opportunity to work on with key G2000 clients Potential to with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world.For more information visit At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, .

Dear Candidate, We are hiring a Scala Developer to work on high-performance distributed systems, leveraging the power of functional and object-oriented paradigms. This role is perfect for engineers passionate about clean code, concurrency, and big data pipelines. Key Responsibilities: Build scalable backend services using Scala and the Play or Akka frameworks . Write concurrent and reactive code for high-throughput applications . Integrate with Kafka, Spark, or Hadoop for data processing. Ensure code quality through unit tests and property-based testing . Work with microservices, APIs, and cloud-native deployments. Required Skills & Qualifications: Proficient in Scala , with a strong grasp of functional programming Experience with Akka, Play, or Cats Familiarity with Big Data tools and RESTful API development Bonus: Experience with ZIO, Monix, or Slick Soft Skills: Strong troubleshooting and problem-solving skills. Ability to work independently and in a team. Excellent communication and documentation skills. Note: If interested, please share your updated resume and preferred time for a discussion. If shortlisted, our HR team will contact you. Kandi Srinivasa Reddy Delivery Manager Integra Technologies

Position Summary As a Lead / Architect, you will define and implement cutting-edge UI architectures, frameworks, and best practices to enhance user experiences. Youll collaborate with designers and developers to create intuitive, high-performance web and mobile applications that set new standards in usability and innovation Education BE/B.Tech Master of Computer Application Work Experience Work Experience About 7 to 10 years of Experience in UI application architecture, design and implementation. UI Application Architect with full stack capability for Architecture, Design and Implementation of interactive UI Applications for Data entry, CRUD operations, Approval Workflows, Notification and Alerts, basic reports/dashboards. Strong experience in building UI application with front end application as Angular or React or similar JavaScript based tool and back end application with Python, Flask or Fast API. Experience in end to end Design, development, System & Integration testing and production deployment. Experience in working with testing tools, version control, release management and automation. Experience in working with AWS or Azure Cloud platform, leading RDBMS databases, File Structures like JSON, XML, CSV. Experience in building Application Security with framework for Authentication and Authorization, Data encryption and Security standards and best practices. Knowledge of data modeling concepts and practices for UI Applications Behavioural Competencies Teamwork & Leadership Motivation to Learn and Grow Ownership Cultural Fit Talent Management Technical Competencies Problem Solving Lifescience Knowledge Communication Project Management Attention to P&L Impact Capability Building / Thought Leadership Scale of revenues managed / delivered