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10.0 - 15.0 years
7 - 11 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India
Posted 9 hours ago
2.0 - 5.0 years
3 - 4 Lacs
Baska
Work from Office
Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velocity, non-viable particle count, air flow pattern as per define schedule, review of calibration certificate for measuring devices]. Ensure and updation of periodic performance verification, calibration, Bulk SIP and smoke study schedule as per available data. Review of all AHU PAO test and NVPC report form for periodic verification, Filter Replacement intimation form, Equipment/instrument inward & Deletion intimation slip & all equipments print reports during qualification. Preparation of master document for periodic performance verification of EFU system Preparation & review of SOPs through EDMS Software Execution of FAT and SAT of equipment, facility and utilities as per requirement. Equipment Periodic performance verification schedule preparation, review, updation and provide data required for monthly report preparation. QE related Instrument calibration schedule preparation (Ellab wireless system, Ellab wired system, Rotronic data loggers certificate review and updation as per available data
Posted 1 day ago
2.0 - 7.0 years
1 - 5 Lacs
Chennai
Work from Office
Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com
Posted 1 day ago
8.0 - 10.0 years
7 - 9 Lacs
Pune
Work from Office
Handle Pre - FAT & FAT. Will visit the sites if required. To guide and support Operation at QA/QC team. To communicate with customer . Responsible for inter departmental communication. To Face Internal & external audits. Write technical reports. Provident fund Annual bonus Office cab/shuttle
Posted 1 day ago
2.0 - 7.0 years
4 - 7 Lacs
Vapi, Umbergaon
Work from Office
work experience in field service engineer for pharma Machines. • Hands on experience IQ,OQ,PQ trails and documentation. • Work experience on installation, maintenance, calibration. • Hands on experience for analytical instruments. : Required Candidate profile Bottle packing line & Imprint machines.Dry granulation (Roll compactor). Inspection machine (Viswill inspection).•Work experience on spares & AMC revenue generation.Work experience on calibration :
Posted 3 days ago
1.0 - 6.0 years
2 - 7 Lacs
Hyderabad
Work from Office
IQ, OQ and PQ,execution of Facility, Utility, Equipment and Computer system qualification,Client schedules,Report daily activities and work completion status to Sr. Manager, Validation ,SOPs Validation, Qualification,Calibration activities
Posted 3 days ago
10.0 - 15.0 years
8 - 12 Lacs
Aurangabad
Work from Office
Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong understanding of instrument calibration procedures under cGMP regulations. Proficiency in maintaining IQ, OQ, PQ documentation for laboratory equipment.
Posted 4 days ago
12.0 - 20.0 years
14 - 24 Lacs
Ahmedabad
Work from Office
Major Purpose of the Job: (Exactly spell out key deliveries/results expected from this job) Person should have minimum 12+ years of experience in SAP-PP, SAP-QM, SAP-PM modules Should have implementation experience of S4HANA (Minimum one project) Ensuring Smooth Functioning of SAP-PP/QM/PM modules. To Provide Support in SAP-PP/QM/PM modules for all companies of Cadila. This will include SAP-PP/QM/PM module configuration also. Principal Accountability: (Please write all the major jobs that the employee is required to carry out ) Supporting users in Day to day issues in SAP-PP/QM/PM modules for all companies of Cadila. Knowledge on Product costing (Production order/Process order), MRP, Order execution, Batch management, Make to stock & Make to order scenarios are required. Knowledge on PP-PI (continuous process industry) is essential Coordination with SAP technical team & user to resolve Issues. Good knowledge on other SAP modules like MM, SD, and QM is essential. Knowledge of Functional enhancement Knowledge of FIORI Should make Functional specification for project, enhancement, report development etc. Knowledge of CSV (Computer system validation) will be consider as added advantage
Posted 4 days ago
2.0 - 7.0 years
5 - 15 Lacs
Hyderabad
Work from Office
Title: Instrumentation and Automation Engineer Qualification: B.E in Electrical & Instrumentation Primary Responsibilities: 1. To attend /or supervise all jobs related to Instrumentation Engineering activities in site. 2. Timely execution of all calibrations of equipments/instruments as per schedule coordination with user. 3. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 4. Maintain the Spare parts of all critical Instruments in site. 5. Timely execution and completion of Validation activities to be done in site. 6. Execution of all In-house Projects in instrumentation and automation in site. 7. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Audit readiness Secondary Responsibilities: 1. Preparation and Review of all documents related to engineering. Timely execution and completion of Performance verification of the equipments. Interested candidates can share your resume to [ Careers@curateqbio.com, hasumitha.chitti@curateqbio.com] with relevant subject line.
Posted 5 days ago
3.0 - 8.0 years
3 - 8 Lacs
Bharuch, Dahej, Ankleshwar
Work from Office
The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, qualification of process and utility equipment
Posted 5 days ago
3.0 - 4.0 years
3 - 4 Lacs
Mahasamund
Work from Office
Execution & documentation of cleaning validation Protocol review IQ/OQ/PQ Swab & rinse sampling Regulatory audit support Coordination with cross-functional teams
Posted 5 days ago
1.0 - 5.0 years
3 - 6 Lacs
Raipur
Work from Office
Roles and Responsibility Develop and implement comprehensive test plans to ensure high-quality software products. Collaborate with cross-functional teams to identify and prioritize testing requirements. Design and execute automated tests using various tools and technologies. Analyze and report defects found during testing, working with development teams to resolve issues. Participate in agile development methodologies, providing feedback on product quality and suggesting improvements. Stay up-to-date with industry trends and emerging technologies in QA engineering. Job Requirements Strong understanding of software testing principles, methodologies, and best practices. Experience with automation testing tools and technologies, such as Selenium or Appium. Excellent problem-solving skills, with the ability to analyze complex issues and provide creative solutions. Strong communication and collaboration skills, with experience working with distributed teams. Ability to work in an agile environment, prioritizing tasks and managing multiple projects simultaneously. Strong attention to detail, with a focus on delivering high-quality results.
Posted 1 week ago
3.0 - 6.0 years
4 - 8 Lacs
Bharuch, Dahej, Ankleshwar
Work from Office
Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintain IQ, OQ, PQ documentation for micronizing mills, containment isolators, bulk handling systems, and fluid bed dryers. Ensure documentation aligns with industry GMP, FDA, and other regulatory standards for equipment validation. Support audits by maintaining structured records for qualification processes on day to day basis. Assist in the installation, commissioning, and qualification of high-containment and powder- handling equipment. Coordinate with internal teams and vendors for proper setup and troubleshooting of process equipment, Provide technical support for operation and maintenance of containment solutions. Work with senior engineers to troubleshoot automation systems, PLCs, and electrical components. Analyse equipment efficiency and contribute to continuous improvement initiatives. Maintain electrical consumption reports to optimize operational performance. Required Skills & Qualifications: Bachelor's degree in Engineering (Mechanical / Electrical / Chemical / Pharmaceutical) or relevant field. Hands-on experience with technical documentation processes and validation protocols. Strong understanding of process equipment installation and validation. Experience in project execution and vendor coordination. Familiarity with automation systems, PLCs, and process equipment troubleshooting. Proficiency in MS Office Suite, AutoCAD, and documentation software. If anyone is interested in this role kindly share resume to zalak.rohit@cielhr.com
Posted 1 week ago
7.0 - 12.0 years
35 - 50 Lacs
Hyderabad
Work from Office
Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com
Posted 1 week ago
5.0 - 8.0 years
4 - 5 Lacs
Pune
Work from Office
EXIM: Manage documentation retention of all commercial documents for North America shipments. Follow up for missing documents from all vendors in a timely manner to prevent logistics delays. Goods Receipt of 3rd party invoices in SAP Verification of commercial invoices as per US Customs entries Export Planning & operation. Sales order-Purchase Order Support Sales by managing customer orders, creation of Sales order-Purchase order (SOPO). Coordination with Sales team, inventory team & Planning team to analyze & place order as per business requirement. Support marketing in implementing customer complaints resolution. Creating Standard reports on Open Orders, closed order & Inventory availability and posting transactions on SAP. Resolving the issues with sales order/Purchase order to make smooth shipment. Checking the Import/Export custom document (shipment detail, CTH, duties etc.) of North America shipment & maintain the data. Highlight the concern in EXIM document for resolution & work for solution as well. Customer Services: Support Sales by managing customer orders, document creation, logistics planning and execution, shipment tracking, returns management. Creating Standard reports on Open Orders, Inventory availability and posting transactions on SAP Create Sales Contracts and liaison with Sales / Finance to create sales contracts / orders. Create Documentation, co-ordinate with logistics and warehouse, track shipment and inform customer for sales orders. Assist Key Account Managers in allocation of shortage material and create dispatches as per allocation. Create standard reports on Inventory, open order status for the perusal of planning and sales team. Create return orders, documentation, co-ordinate with logistics and warehouse for all customer returns. Toller: Shipment transaction like STO (Stock transfer), Production posting, BOL creation, PGI & PGR for stock etc. Analysis of stock and input from UPL NAM warehouse & third party and process the transaction in SAP. Other activities Support to any other Logistics function. Work on Improvement projects & process streamline. MIS & Data mining and initiative for improvement within system & process. Excellent in IQ & coordination with stakeholder to resolve the error/problem. Strong Organizational Skills Strong Follow-up Skills SAP and intermediate Excel Written and Verbal Communication Skills International Logistics Experience a plus Preferred Sectors for sourcing the talent – Manufacturing. Resource needs to work in Global region shift as per country time zone. English communication is must & comfortable to work in regional shift time. Logistics/EXIM knowledge is required. Education - bachelor’s degree/MBA in SCM or IB. Experience - 3 to 6 years Preferred location from Pune /Nearby Pune.
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
As an Electrician Diploma at Surmount Laboratories Pvt. Ltd., you are expected to have a minimum of 2 to 5 years of experience with a strong understanding of HU DY System Knowledge. Your responsibilities will include pre-balancing, filter cleaning work, documentation work, as well as knowledge in IQ, OQ, PQ, DQ HVAC Qualification. Additionally, you will be responsible for preventive maintenance documentation and general documents related to the field.,
Posted 1 week ago
1.0 - 5.0 years
2 - 5 Lacs
Sanand
Work from Office
Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title - Maintenance Officer / Sr. Officer Role & Responsibility Follow the cGMP and GDP Procedure. Develop maintenance procedures and ensure implementation. Carry out inspections of the facilities to identify and resolve issues. Plan and oversee all repair and installation activities. Keep generator, lighting and electrical system in working order. Diagnose problems and then repair/replace defective parts. Preparing all the documents (like SOPs, related log sheets, etc.) related to the maintenance department. Inspecting the validation and calibration activity of the clean room and other equipment as needed. Perform mechanical and electrical maintenance repair work; install/ replace fixtures, switches, motor, receptacles, and wiring. Execute PPM (Planned Preventive Maintenance) of equipment, maintains records and logs as needed. Provides guidance and directions to less experienced personnel and others assigned to his/ her position. Performs all work in accordance with all established regulatory and compliance as per safety requirements. Responsible to source, negotiate and purchase materials from local vendors. Evaluate vendor s quotation to ensure that they are in line with the technical specification required for the project. Any additional job responsibilities as assigned by HOD. Perform other various task as instructed by management. Department : Maintenance Number Of Positions : 01 Experience : 1 to 6yrs Employment Type : Full Time, Permanent Education : UG: B.Tech, BEE (Mechnical / Electrical) Compensation : As per Industry norms & experience Key Skills : PPM, Maintenance Management, SOPs, cGMP and GDP Procedures, Utility Maintenance.
Posted 1 week ago
6.0 - 8.0 years
5 - 15 Lacs
Bengaluru
Work from Office
We are hiring for IT Engineer for IT Department. Experience : 6 to 8 years . Location: Bommasandra API Plant Roles and Responsibility: 1. Providing IT support for performing IQ/OQ/PQ of any Hardware/Software implementation. 2. Handling of deviation,change control and CAPA in caliber QAMS 3. Performing/reviewing preventive maintenance for all GxP and Non-GxP Desktop/Laptop as per the schedule. 4. Providing QC Software support for creation/modification/disable of user id/user type, resetting the user password based on the request and rectifying any software issues etc. 5. Evaluate and / or recommend purchases of computers, VDI systems, network hardware, printers, cartridges, peripheral equipment and software. 6. Performing/reviewing back up and restoration of data kept in all servers and standalone instrument computers as per the schedule. 7. Preparing/reviewing the report for IT related activities and softwares. 8. Installation and troubleshooting of all types Workstation, Server, Backup device, OS, database, Network, Softwares and instrument related application. 9. Maintenance of EPBAX and CCTV system.
Posted 1 week ago
3.0 - 6.0 years
4 - 8 Lacs
Gurugram
Work from Office
About the Opportunity Job TypeApplication 31 July 2025 Title Supplier Relationship Manager Department Procurement Location Gurgaon, India Reports To Head of Supplier Relationship Manager Level Grade 5 We are proud to have been helping our clients build better financial futures for over 50 years. How have we achieved thisBy working together - and supporting each other - all over the world. So, join our team and feel like youre part of something bigger. About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe, and Asia Pacific, overseeing spend of ~$700m in 26 countries. The existing SRM function is established to ensure alignment and a drive best practice supplier relationship management across all FIL supplier management activity globally. The SRM will be part of a global team covering UK / Ireland / India, forming a broader community with ~6 colleagues in Gurgaon who will undertake common supplier management tasks and providing CoE support. The SRM will demonstrate behaviours which meet FILs core values, evidence an ability to work collaboratively across FIL, and role model leadership on key programmes such as ESG. About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited tosenior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and relationship management to create clear supplier strategies (commercial, contractual and risk) for a defined element of the supplier portfolio, and will ensure the requirements contractual obligations, Procurement policy, and business unit objectives are met and evidenced in regular routines. About you Previous experience as a Supplier Relationship Manager is essential, with at least 3 years SRM FS experience desired. Experience of working within an Enterprise Risk Management framework model, with knowledge of the 3LoD model. It is essential the role holder demonstrate behaviours aligned to FILs Values and Behaviours. It is desirable for the role holder to have sound knowledge of key global regulations pertaining to Outsourcing and controls. Commercial awareness and ability to partner with Procurement to negotiate fees and contracts. Enthusiastic, self-driven and with a high level of self-motivation to overcome obstacles and a strong desire to make things happen. Strong personal presence, excellent interpersonal and communication skills, ability to establish a successful rapport, communicate and influence at all levels. Excellent organisational skills, presentation of reports and attention to detail. Strong decision-making skills. Ability to be flexible and responsive to a constantly changing environment. Feel rewarded For starters, we will offer you a comprehensive benefits package. We will value your wellbeing and support your development. And we will be as flexible as we can about where and when you work finding a balance that works for all of us. It is all part of our commitment to making you feel motivated by the work you do and happy to be part of our team. For more about our work, our approach to dynamic working and how you could build your future here, visit careers.fidelityinternational.com.
Posted 1 week ago
4.0 - 7.0 years
2 - 6 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, Revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.
Posted 1 week ago
6.0 - 11.0 years
8 - 14 Lacs
Telangana
Work from Office
We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.
Posted 1 week ago
10.0 - 12.0 years
10 - 14 Lacs
Mumbai
Work from Office
Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders and produce useful reports. Ability to conduct market research for product development Knowledge of cloud platforms (Fundamentals of GCP/AWS/Azure) GDPR, HIPAA/GXP compliance, ERP and SAP application Role Lead the delivery of multi-functional, large-scale Cloud transformation projects Conduct a thorough review of all components in the Project/Program Plan: scope, deliverables, time frame, and cost Stakeholder management ( Internal and external ) Manage the risks, issues, scope changes, unplanned events and other actions of the project and regularly track them to meet the expected outcomes and timelines, building mitigation plans as the program evolves. Work closely with Developers, BA, Quality, Engineering, and cross-functional team to resolve issues that arise during design, implementation and in post-production. Work with external and internal partners on integration and product expansion opportunities.
Posted 1 week ago
8.0 - 12.0 years
8 - 13 Lacs
Bengaluru
Work from Office
Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. As an Engineer for E+ES India team, you will have opportunities to contribute on complex projects via Simulation, Development and Validation of complex electrical systems pertaining to battery management and battery chemistry. This will involve creating world class control software and evaluating software features using HIL benches. This role directly impacts Caterpillars current and future Battery and microgrid products being developed in an R&D environment. Job Duties/Responsibilities may include, but are not limited to: Define battery control strategy requirements and develop software features using tools like Matlab/Simulink/Simscape Develop test plans from software requirements and specifications Perform Black box testing and White box testing using simulators like Opal-RT, dSPACE, etc Run and execute battery test plans in battery cell simulators and HIL benches Modify and convert battery simulation models using MATLAB/Simulink tools for HIL Bench Develop automation scripts using Python and other tools Perform complex analysis, identify, and solve challenging battery controls software problems Lead new capabilities / projects to enhance the BMS controls and validation Basic Qualifications: Bachelors degree in Electrical/Electronic/ Mechanical Engineering 8 to 12 years experience with HIL testing, battery controls validation or modelling Experience in debugging and running test cases on Battery cell simulators and other HIL simulators Experience in plant model integration using tools like Matlab/Simulink, RT-Sim, Vector Canape, etc Experience and knowledge with Controls SW development and Validation Top Candidates Will Also Have: Experience and knowledge with Battery Management control system and battery software validation using HIL Benches Masters degree in an accredited Indian or Global Engineering schools Good knowledge of simulation tools like Simscape electrical etc Good knowledge on Software testing and scripting tools like Canalyzer, Python, etc Excellent analytical and communication skills Self-starter with strong technical leadership skills Enjoys working in a fast paced, technically challenging environment Posting Dates: July 2, 2025 - July 17, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community.
Posted 1 week ago
10.0 - 15.0 years
15 - 20 Lacs
Pune
Work from Office
Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organizations adopting strategies relating to NextGen/ New age Data Capabilities Be proficient in evaluating new technologies and identifying practical business cases to develop enhanced business value and increase operating efficiency Architect large scale AI/ML products/systems impacting large scale clients across industry Own end to end solutioning and delivery of data analytics/transformation programs Mentor and inspire a team of data scientists and engineers solving AI/ML problems through R&D while pushing the state-of-the-art solution Liaise with colleagues and business leaders across Domestic & Global Regions to deliver impactful analytics projects and drive innovation at scale Assist sales team in reviewing RFPs, Tender documents, and customer requirements Developing high-quality and impactful demonstrations, proof of concept pitches, solution documents, presentations, and other pre-sales assets Have in-depth business knowledge across a breath of functional areas across sectors such as CPRD/FS/MALS/Utilities/TMT Your Profile B.E. / B.Tech. + MBA (Systems / Data / Data Science/ Analytics / Finance) with a good academic background Minimum 10 years + on Job experience in data analytics with at least 7 years ofCPRD, FS, MALS, Utilities, TMT or other relevant domain experience required Specialization in data science, data engineering or advance analytics filed is strongly recommended Excellent understanding and hand-on experience of data-science and machine learning techniques & algorithms for supervised & unsupervised problems, NLP and computer vision Good, applied statistics skills, such as distributions, statistical inference & testing, etc. Excellent understanding and hand-on experience on building Deep-learning models for text & image analytics (such as ANNs, CNNs, LSTM, Transfer Learning, Encoder and decoder, etc). Proficient in coding in common data science language & tools such as R, Python, Go, SAS, Matlab etc. At least 7 years experience deploying digital and data science solutions on large scale project is required At least 7 years experience leading / managing a data Science team is required Exposure or knowledge in cloud (AWS/GCP/Azure) and big data technologies such as Hadoop, Hive What you will love about working here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as Generative AI. About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.
Posted 2 weeks ago
2.0 - 4.0 years
4 - 5 Lacs
Khopoli
Work from Office
Role & responsibilities Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports . Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines , and internal SOPs. Perform gap assessments, risk assessments , and deviation handling related to validation. Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections , and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly. Skills & Competencies B. Pharm / M. Pharm / M.Sc. in relevant field. Minimum 4 years of hands-on experience in QA validation functions in a regulated pharmaceutical manufacturing environment. Strong understanding of equipment and utility qualification, cleaning validation, CSV, and process validation . Familiar with guidelines such as GAMP 5, 21 CFR Part 11, ICH Q8-Q10 , and applicable regulatory standards. Good documentation and analytical skills. Proficient in MS Office , knowledge of QMS software is an advantage. Strong communication and coordination skills.
Posted 2 weeks ago
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