272 Csv Jobs - Page 8

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. WFO, Mumbai - Immediate - 15 Days

We are hiring for : Global SAP Program Director & Head of SAP Platform This role will lead the global SAP S/4HANA implementation and transition post go-live into owning SAP as a platform and leading the SAP CoE for continuous improvement and global rollout support. Position Overview: The Global SAP Program Director will lead the successful implementation of SAP S/4HANA across all regions (U.S., India, Ireland), serving as the single point of accountability for program delivery, scope, schedule, budget, and quality. This is a multi-year, enterprise-scale transformation involving finance, supply chain, manufacturing, quality, compliance, and commercial operations. Upon successful go-live, the role will transition to become the Global Head of SAP Platform , responsible for overseeing the SAP Center of Excellence (CoE), ensuring the stability, scalability, and strategic evolution of SAP as the digital backbone of the enterprise. Key Responsibilities: Phase 1: Implementation Leadership Own the global SAP S/4HANA program end-to-end: strategy, execution, issue resolution, and stakeholder alignment. Lead a cross-functional, cross-regional team of internal and external resources (including SI partners, integration partners, and business leads). Ensure successful design, testing, data migration, training, cutover, and hypercare for all program phases. Establish and chair program governance structures (Steering Committees, Design Authorities, etc.). Monitor and report program KPIs, risks, mitigations, and readiness metrics to senior leadership. Coordinate change management and communication in partnership with functional leaders and HR. Phase 2: SAP Platform Ownership Transition into leading the SAP CoE post go-live. Build and lead a team of SAP functional, technical, and support resources to stabilize and evolve the platform. Define and drive the roadmap for enhancements, integrations, and new module rollouts. Ensure strong alignment with business process owners across Finance, Supply Chain, Manufacturing, Quality, and Commercial. Drive continuous improvement, user adoption, and value realization from the SAP investment. Collaborate with cybersecurity, infrastructure, and data teams to ensure compliance, performance, and data integrity. Organizational Alignment: This position will report directly to the Global CIO and act as the single point of accountability for SAP globally. Will collaborate closely with the AVP of India IT and VP of U.S. IT for regional execution. Will manage internal SAP leads and partner teams to ensure delivery and post-go-live platform success. Qualifications: 20+ years of experience in IT or ERP leadership, with 10+ years leading large-scale SAP programs. Proven track record delivering complex, multi-region ERP transformations (ideally in pharma, life sciences, or manufacturing). Must understand U.S. GAAP and Sarbanes-Oxley controls and compliance requirements. Prior leadership experience in a regulated industry (GxP). Familiarity with validated systems and CSV processes. Strong understanding of SAP S/4HANA core modules (FICO, MM, SD, PP, QM) and integration platforms (e.g., Boomi, CPI). Demonstrated ability to manage vendors, budgets, timelines, and executive stakeholders under pressure. Experience building and leading ERP teams, including functional analysts, architects, developers, and support staff. Exposure to enterprise data strategy, master data governance, and business transformation. Excellent communication, influence, and executive presentation skills.

We are looking for a highly skilled and experienced professional to join our team as a Customer Service Representative in the retail sales department, located at Tata Capital Limited, Varanasi - Tulsi Complex - J Grades. The ideal candidate will have 6-8 years of experience in customer service or sales. Roles and Responsibility Handle customer inquiries and resolve issues professionally. Provide excellent customer service and ensure satisfaction. Meet sales targets and achieve performance goals. Collaborate with internal teams to improve processes and procedures. Develop and maintain strong relationships with customers and colleagues. Stay updated on products and services to provide accurate information. Job Strong communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Excellent problem-solving and analytical skills. Proficient in using computer systems and software applications. Strong attention to detail and organizational skills. Ability to work collaboratively as part of a team. Experience in housing and EM sales is an added advantage. For more information, please contact us at 6586287.

# Work from Office only. Role & responsibilities: Role Digital Team Member Person will be part of digital team and helping the digital team members for digital initiatives and implementing various digital tool at the manufacturing site. Individual Contributor Location – Ahmedabad, Manufacturing Site / Corporate Department – Digitization (Central Team driving Digital and Industrial Automation across Mfg and Quality verticals) Reporting – Team Lead – Digitalization Roles & Responsibilities: Working with leaders across the organization for identifying and conceptualizing potential digital transformation solutions on the manufacturing shop floor. Drive digital Business Process Transformation solutions for Manufacturing operations in collaboration with respective digital & process excellence teams. Conceptualize potential new digital platform business models and solution opportunities with an aim of creating competitive advantage and new business models. Drive multiple digital projects from concept till launch and ensure delivery of digital solutions as per budgeted cost, timelines and quality. Contribute in building Digital Quotient across the organizations through Trainings & Workshops on new & emerging digital technologies and their potential use cases. Ensure successful adoption and scale-up of digital programs. Working effectively with cross functional team members Adherence to Digital Product/Solution Development best practices and processes such as Design Thinking & Agile Scrum for ensuring optimum program outcomes. Managing and grooming the users on the manufacturing site and external partner management. Defining and leading execution of technology proof of concepts to evaluate disruptive technologies. Driving solution adoption and scale up as per defined product roadmap for ensuring planned value realization. Required Technical and Professional Expertise Minimum 5+ years of experience in leading Digital Transformation Initiatives with excellent understanding of digital technologies such as Mobility, AI, IoT & Computer Vision. Proven success in driving Digital Solution / Platforms / Digital Product development and management in Pharmaceutical company. Ability to think strategically & creatively. Good understanding of Digital Platform Thinking and ability to create Digital Business Models. B. Tech / B.E. / B.S. /M.sc / M.Pharma Ability to prioritize and manage multiple initiatives simultaneously. Ability to lead and manage a Team of Business Analysts, Project Managers, Partners and Technology Specialists. Proven success in driving programs as per agile methodologies and apply design thinking process for developing innovative and cutting edge technologies digital solutions.

Dear Candidate, We are hiring a Scala Developer to work on scalable data pipelines, distributed systems, and backend services. This role is perfect for candidates passionate about functional programming and big data. Key Responsibilities: Develop data-intensive applications using Scala . Work with frameworks like Akka, Play, or Spark . Design and maintain scalable microservices and ETL jobs. Collaborate with data engineers and platform teams. Write clean, testable, and well-documented code. Required Skills & Qualifications: Strong in Scala, Functional Programming, and JVM internals Experience with Apache Spark, Kafka, or Cassandra Familiar with SBT, Cats, or Scalaz Knowledge of CI/CD, Docker, and cloud deployment tools 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 Delivery Manager Integra Technologies

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

Overseeing all training activities to ensure team competency and compliance. Help in Conducting audit planning and executing audits of various applications and departments. Reviewing validation documents to ensure compliance and accuracy. Performing peer reviews of audit plans, reports, and observations, and effectively communicating with auditors to clarify findings, ratings, and supporting evidence. Managing change requests, deviations, quality issues, CAPA (Corrective and Preventive Actions), effectiveness checks, and conducting root cause analysis. Assisting in the development of Key Performance Indicators (KPIs) for Quality Management System (QMS) performance monitoring and management oversight. Supporting the continuous improvement and operational success of the quality assurance function. Perform the assigned activities given by them as defined in the SOP Ensure that QA practices and deliverables comply with regulatory requirements and industry standards. Oversee the planning, execution, and documentation of all QA activities, including functional testing, regression testing, performance testing, and validation testing. Collaborate with development teams to identify and resolve defects and ensure the timely delivery of high-quality software releases. Collaborate with stakeholders to develop validation plans and protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT). Prepare and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices, in compliance with regulatory requirements and internal procedures. In-depth knowledge of regulatory requirements and guidelines governing CSV, including FDA regulations (21 CFR Part 11, 21 CFR Part 210/211), GxP, GAMP, Annex 11, and other relevant standards (e.g., ISO 27001, ISO 9001). Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements to validation activities and systems. Qualifications: Strong understanding of quality assurance processes and regulatory requirements. Excellent analytical and communication skills. Ability to work collaboratively within a team and manage tasks effectively. understanding QA terminologies, exposure to any QMS database will be of added advantage

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

Tech stack GCP Data Fusion, BigQuery, Dataproc, SQL/T-SQL, Cloud Run, Secret Manager Git, Ansible Tower / Ansible scripts, Jenkins, Java, Python, Terraform, Cloud Composer/Airflow Experience and Skills Must Have Proven (3+ years) hands on experience in designing, testing, and implementing data ingestion pipelines on GCP Data Fusion, CDAP or similar tools, including ingestion and parsing and wrangling of CSV, JSON, XML etc formatted data from RESTful & SOAP APIs, SFTP servers, etc. Modern world data contract best practices in-depth understanding with proven experience (3+ years) for independently directing, negotiating, and documenting best in class data contracts. Java (2+ years) experience in development, testing and deployment (ideally custom plugins for Data Fusion) Proficiency in working with Continuous Integration (CI), Continuous Delivery (CD) and continuous testing tools, ideally for Cloud based Data solutions. Experience in working in Agile environment and toolset. Strong problem-solving and analytical skills Enthusiastic willingness to learn and develop technical and soft skills as needs require rapidly and independently. Strong organisational and multi-tasking skills. Good team player who embraces teamwork and mutual support. Nice to Have Hands on experience in Cloud Composer/Airflow, Cloud Run, Pub/Sub Hands on development in Python, Terraform Strong SQL skills for data transformation, querying and optimization in BigQuery, with a focus on cost, time-effective SQL coding and concurrency/data integrity (ideally in BigQuery dialect) Data Transformation/ETL/ELT pipelines development, testing and implementation ideally in Big Query Experience in working in DataOps model Experience in Data Vault modelling and usage. Proficiency in Git usage for version control and collaboration. Proficiency with CI/CD processes/pipelines designing, creation, maintenance in DevOps tools like Ansible/Jenkins etc. for Cloud Based Applications (Ideally GCP)

Urgent Opening for ETL Testing Opening - Software - Bangalore Posted On 17th Jun 2016 12:12 PM Location Bangalore Role / Position ETL Testing Experience (required) 4 plus years Description Our client is a start up founded in 2009, develops products and solutions in Customer Success Management (CSM). They've received a $54 million venture funding since 201 2 and are expanding their team. They've a 130+ member team (Hyderabad + US). Position: ETL Testing Location: Bangalore Experience: 4 plus years(exp in SQL Queries) Job description Reading and writing data to S3 buckets/MongoDB/Redshift Data migration from one db to another Checking the DB performance Very good at writing SQL queries Good understanding of SQL best practices Preparing large data sets for Performance testing Security aspects in DB(add on) Understanding of different data sources - CSV, JSON, XML If interested, please share the update profile along with ctc details Send Resumes to kishore.expertiz@gmail.com -->Upload Resume

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

Knowledge over BTP cockpit and tenant setup.o Understanding on migration assessment toolo Experience on cloud connector setupo Experience in custom interface implementationo HTTP, FTP/SOAP, OData, REST, JMS Adaptoro Experience in web service interface implementationo Key based and certificate-based authentication.o XSLT, Message mappingo Groovy, Java scriptingo Data Converters (XML, JSON, CSV)o PGP Encryption, Decryptiono Experience in CPI Pre-packaged interface configurationo Handling "Manage

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Lets find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow

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

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

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.

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.

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

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

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

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

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.

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

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

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