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5.0 - 10.0 years

17 - 22 Lacs

Hyderabad

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Employee type : C2H Position of the role The role reports into the Global Account Director and is part of the Global Customer Success Team. Result expectation in terms of result areas and core activities The Customer Success Integration Manager will define and deliver the data & integration configuration of the Clients tool within the scope of the Statement-of-Work that will bring value to the customer, is in use and accepted by that customer, complies with the Clients blueprint and is properly handed over the Customer Engagement Department at project closure. Main objectives of the role Pre-Project Assessment: Support the Integration Lead and other involved people in defining the Statement-of-Work for a Customer Deployment Project, specifically focused on the Data & Integration scope. Gain appreciation of the Customer Business Case and Business Drivers Project Execution (VDA): Initiate: support the creation of the Project Plan and kick-off Activate: accountable for the activate activities to ensure the RGM platform gets prepared with data and will be ready for configuration. Configure: accountable for the activities to realize the outbound integrations and support the functional manager with all configuration activities Launch: support the End-to-End testing, cut-over and go-live, and responsible for hypercare and handing over to Customer Engagement. Project Management: support the Project Manager in executing, planning and management of the project. Detailed RASCI can be found in the VDA documentation General Responsibilities Build strong relation with the customer stakeholders (integration focused). Understand the customer requirements that are in scope of the project and understand how these requirements are solved via the Blueprint solution that will be provided. Identify potential additional requirements and discuss these with the Integration Lead. Outcome to be communicated with the customer. Have a good understanding of the agreed customer blueprint and data & integration architecture Understand standard ERP processes & architectures used in the CPG industry (mainly SAP) Have an appreciation of agile project management tools and shared workspaces Build strong relationships with the R&D teams in order to deliver configurations that need development support. This includes providing thorough specifications (using templates) and provide clarity on timelines. Requirements Bachelors degree in computer science or equivalent and 7+ years of work experience in the IT industry. Experience with ERP systems implementations like SAP (TPM/SD) and Oracle, Experience with in-depth data interfaces (IDOC, XML, CSV, JSON) Experience with data analysis and data manipulation with large datasets Strong knowledge of (Traditional & MongoDB) databases Appreciation of Cloud solutions like AWS cloud Appreciation of software delivery/development and project management Experience in working with global teams and global customers Excellent verbal and written communication skills in English language Excellent interpersonal, organizational and leadership skills Accountable team member able to work autonomously and with attention to detail Experience in using tools to support daily processes like Atlassian, Microsoft, ProdPad and Zendes

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8.0 - 13.0 years

10 - 20 Lacs

Hyderabad

Hybrid

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Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

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5.0 - 10.0 years

15 - 30 Lacs

Noida

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Ultragenic brings together Life sciences domain expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across the Pharmacovigilance function. Our solutions are agile, flexible and scalable, developed using advance technologies such as AI, Machine learning and Robotic process automation that enable us to serve large and small organizations, both in developed and emerging markets. With rich experience in engineering and deploying best-in-class life sciences solutions, our team is well placed to help achieve your goals. Skills Experience of design, development and deployment of multi-dimensional reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Experience in Oracle PL/SQL and writing efficient SQL queries. Experience of creating excel based and RTF template based OBIEE Reports is a plus. Good experience in database concepts, and any ETL tool is added advantage. Good understanding of DW concepts and Analytical skills. Good experience in Performance tuning to ensure reports function within acceptable parameters. Good to have pharmacovigilance domain exposure. Responsibilities Work with business users to design and develop Custom Reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Prepare all designs and code for various Custom Reporting objects and ensure compliance with all best business practices in the industry. Understand business requirements, relational databases, and data models. Authoring of installation specifications and execution of unit testing. Be responsible for authoring project documentation/deliverables. Facilitate/contribute to client demo sessions/workshops.

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7.0 - 12.0 years

0 - 1 Lacs

Noida, Hyderabad

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I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

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6.0 - 8.0 years

5 - 8 Lacs

Hyderabad

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Candidate must have hands on experience in Werum PAS-X/FTPS/Syncade/Opcenter development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

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6.0 - 10.0 years

8 - 12 Lacs

Hyderabad

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Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

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2.0 - 7.0 years

3 - 7 Lacs

Jadcherla

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HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE Experience: (01-07Years) Raw Material, Packing Material, Finished Goods QUALIFICATION : I.T.I, Diploma, B.Com, B.Sc, B.Tech, B. Pharm, M.Sc with relevant experience DESIGNATIONS: Operator, Sr.Operator, Jr.Officer, Officer, Jr.Executive, Executive & Sr. Executive INTERVIEW VENUE: Hotel: UJWALA GRAND Gandimaisamma, gandimaisamma- Medak Road, Hyderabad, Telanagana- 500043 DATE &TIME: 28th & 29th June'2025 (Saturday & Sunday); From 09.00 A.M. to 03.00 P.M NEED TO CARRY: Resume, 3 Month Pay slips, Increment letter, Previous company relieving letters, Education Documents and ID Proofs Help Us Spread the Word (Refer): Circulate it in your Social Networking sites and groups for better reach and Refer your friends and colleagues, it could be a great opportunity for someone in need! CONTACT INFO: E-mail: Harishwar.m@hetero.com & Cont: 8121036004 for further info

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7.0 - 10.0 years

12 - 16 Lacs

Hyderabad

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Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

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4.0 - 9.0 years

14 - 24 Lacs

Bengaluru

Remote

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Data Quality Analyst (Exp. 6-10 years) Key Responsibilities: Review data extracts (CSV, GeoPackage) via FME or internal systems. Analyze quality dashboards to identify patterns of data issues, including: Textual issues: incorrect/missing IDs, invalid relations, address mismatches, date inconsistencies. Spatial issues: invalid geometries, overlaps, incorrect boundary placements, zero-area polygons. Classify and prioritize issues by severity and type. Translate dashboard insights into clear, actionable instructions for the Operations team to resolve. Collaborate with Data Engineers to update validation rules and dashboards as needed. Maintain issue logs and validation reports for audit trail and status tracking. Provide feedback to Local Authorities regarding common recurring issues and recommended best practices. Liaise with GIS teams to verify complex spatial anomalies when required. Required Skills & Experience: Bachelor's degree in GIS, Data Analytics, Computer Science 46 years of experience in data validation, spatial data analysis, or QA in government/public sector projects. Strong hands-on experience with spatial data formats: Shapefile, GeoPackage (GPKG), WKT, GeoJSON. Familiarity with tools such as QGIS, ArcGIS, or FME. Proficiency in PostgreSQL/PostGIS or other spatial databases. Ability to read and interpret data dashboards and translate findings into business-friendly actions. Strong communication skills for coordinating across data, operations, and local authority teams. Preferred (Nice to Have): Understanding of Local Land Charges (LLC) and HM Land Registry data standards in UK. Experience working with Idox Uniform, CCF, or FME-based pipelines. Exposure to AI-based tools for anomaly detection or NLP-based document parsing.

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2.0 - 7.0 years

2 - 7 Lacs

Ahmedabad

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Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufacturing system. Experience of SOP preparation Preparation of inventory list, periodic review schedule, periodic review report Designation : Executive/Senior Executive Experience: 05 - 09 years

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2.0 - 7.0 years

3 - 8 Lacs

Ahmedabad

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

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0.0 - 1.0 years

2 - 3 Lacs

Bengaluru

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

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0.0 - 1.0 years

2 - 3 Lacs

Bengaluru

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Responsibilities: * Conduct quality assurance activities using CSV, QMS, SOPs. * Collaborate with teams on training management. * Ensure compliance with industry standards through QA tools. Health insurance Maternity policy Gratuity Provident fund Maternity leaves Paternity leaves Job/soft skill training

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6.0 - 11.0 years

6 - 16 Lacs

Hyderabad

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

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9.0 years

8 - 12 Lacs

Hyderabad

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

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6.0 - 10.0 years

15 - 16 Lacs

Visakhapatnam

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

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6.0 - 10.0 years

5 - 8 Lacs

Kolkata, Mumbai, New Delhi

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

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3.0 - 8.0 years

8 - 14 Lacs

Hyderabad, Chennai, Bengaluru

Hybrid

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

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7.0 - 12.0 years

5 - 14 Lacs

Bengaluru

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

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1.0 - 6.0 years

10 - 15 Lacs

Bengaluru

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

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10.0 - 14.0 years

15 - 20 Lacs

Gurugram

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

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12.0 - 16.0 years

12 - 20 Lacs

Hyderabad

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Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations and industry best practices. Ensure validation lifecycle management, including periodic review, re-validation, and change control assessments. Collaborate with IT, Quality, Engineering, Production, and external vendors to ensure smooth implementation and validation of new computerized systems or upgrades. Drive data integrity initiatives and compliance across computerized systems and related workflows. Conduct internal audits, gap assessments, and readiness checks for regulatory inspections related to CSV. Provide training and guidance to cross-functional teams on CSV policies, procedures, and regulatory updates. Track regulatory developments and industry trends to continuously improve CSV and data integrity frameworks Preferred candidate profile B.E./B.Tech or a Masters in Pharmacy with 12 - 16 years of experience in Computer System Validation within regulated pharmaceutical manufacturing, preferably injectable / sterile dosage forms. Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Hands-on experience with LIMS, ERP, SCADA, BMS/EMS, and electronic batch records. Experience in handling regulatory inspections (e.g., USFDA, MHRA, EU, WHO) from a CSV perspective

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1.0 - 5.0 years

3 - 9 Lacs

Hyderabad, Pune, Bengaluru

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

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5.0 - 6.0 years

3 - 5 Lacs

Pune

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

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6.0 - 11.0 years

6 - 10 Lacs

Hyderabad

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

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