107 Validation Jobs - Page 2

Position : Power BI Lead Engineer Experience : 9 +years Hybrid mode Shift Timings : 2PM -11PM Location : Bangalore, Chennai & Hyderabad and Pune. Responsibilities Lead the offshore Power BI development team. Oversee the development and testing of Power BI reports and dashboards. Ensure adherence to project timelines and quality standards. Collaborate with the onshore architect and project manager. Provide technical guidance and support to the offshore team. Work with the data engineers to validate the data within snowflake and teradata. Skills to Have Strong leadership and communication skills. Extensive experience with Power BI development. Proficiency in DAX, Power Query, and data modeling. Experience with Agile development methodologies. Ability to manage and mentor a team. Testing and validation of the user stories developed by engineers Remove any bottlenecks and technical impediments for the project Technologies (Must Have): Power BI (Desktop, Service) DAX, Power Query (M), Copilot. PowerBI Reports Builder SQL Python MicroStrategy, WebFocus : good to have Snowflake : basic knowledge is must Technologies (Good to Have): Azure cloud platform or Any cloud is fine good to have Exposure to PowerBI Rest APIs PowerBI External Tools Custom Visuals

Introduction As a Hardware Developer at IBM, youll get to work on the systems that are driving the quantum revolution and the AI era. Join an elite team of engineering professionals who enable IBM customers to make better decisions quicker on the most trusted hardware platform in todays market. Your Role and Responsibilities : We are seeking highly motivated DFT engineer to be part of Hardware team. Join a great team of engineering professionals who are involved in development, validation, and delivery of DFT patterns for IBMs microprocessor chip design team. As a member of functional DFT team ( Power on Reset, Architecture Verification Program, Array BIST teams ), you will be required but not restricted to pattern generation, simulation, validation, characterization, delivery to TAE, IBMs Hardware Bring-up and Silicon Debug Your role and responsibilities We are seeking highly motivated DFT engineer to be part of Hardware team. Join a great team of engineering professionals who are involved in development, validation, and delivery of DFT patterns for IBMs microprocessor chip design team. As a member of functional DFT team ( Power on Reset, Architecture Verification Program, Array BIST teams ), you will be required but not restricted to pattern generation, simulation, validation, characterization, delivery to TAE, IBMs Hardware Bring-up and Silicon Debug Required education Bachelors Degree Preferred education Masters Degree Required technical and professional expertise 5-9 years experience in DFT on complex designs involving scan insertion, compression, MBIST, ATPG, simulations and IP integration and validation.Proven expertise in analysing and resolving DRCs/TSVs .Hands-on experience in pattern generation for various fault models, pattern retargeting and debugging techniques to address low coverage issues.Hands-on experience with Gate-Level DFT verification, both with and without timing annotations.Well versed with industry standard test techniques and advanced DFT features like SSN, IJTAG, IEEE 1500, Boundary scan , LBIST and STA constraint delivery .Hands on experience on industry standard tools used for DFT featuresProficiency in scripting languages such as TCL, Perl or Python to automate design and testing tasks.Worked with cross functional teams like design, STA & tester teams for ensuring top quality of DFT deliverables and DFT support and hand offs.Excellent analytical and problem-solving skills, with a keen attention to detail.Strong communication and collaboration skills, with the ability to work effectively within cross-functional teams Fundamentals in micro controller architecture, embedded firmware, functional verification and RTL design . Experience working with ATE engineers for silicon bring up, silicon debug and validation. . Experience in processor flow and post silicon validation Preferred technical and professional experience Hiring manager and Recruiter should collaborate to create the relevant verbiage.

raja.a@honeybeetechsolutions.com resume share to MCAL Driver Expertise: Strong Experience with drivers like MCU, PWM, GPT, WDG, ADC, DIO, PORT, MEM, SPI, UART, CDD; SWC Creation and Development; BSW Configuration DaVinci Configurator: Proficient in using DaVinci Configurator and Developer tools. Automation of DaVinci Configurator with Groovy Scripting. Good in Embedded C Programming SWS Documents: Strong understanding and implementation skills of MCAL. API & Configuration: Strong understanding of MCAL various APIs and configuration parameters.

Team manager with good leadership skills Design, configuration, integration and implementation of process control solutions for various industries Develop P&IDs and loop descriptions for various plants, processes, and/or equipment. Develop User Requirement Specifications. Develop software and hardware design specifications. Design, program, implement, test and document process control applications. Develop control system validation/testing protocols. Specify and purchase Siemens/Rockwell components, drives, and other electrical components and equipment. Develop electrical panel schematics. Manage automation projects as assigned. Monitor progress of projects. Install, test, and start-up control systems on-site Required Candidate profile A Bachelors degree in Electrical / Electronics / Instrumentation / Computer Science Engineering or equivalent combination of education and technical experience. A minimum of five (6) years of experience in either a consulting engineering firm or operating engineering environment. Thorough knowledge of process instrumentation and control systems. Knowledge of and familiarity with the National Electric Code (NEC) and international standards. Experience designing and programming control systems with emphasis on Siemens or Rockwell controls. Experience in commissioning and startup of control systems is required. Ability to work with plant engineers, external vendors, operators and management to manage projects and assignments is essential. Ability to troubleshoot control systems from the field element up through operator interfaces and databases. Experience with control system networking technologies and PC networking technology. Experience working with SQL Server, Oracle, or other relational databases. Any experience with Visual Basic scripting is a big plus. Excellent written and verbal communication skills. Strong interpersonal skills and the ability to work in a team environment. Ability to work effectively in a fast paced multi-tasking environment. Experience in biotech/pharma, water, wastewater, medical device, or the food industry is required. Experience with PLC, HMI, and SCADA systems is a plus Specific knowledge of cGMPs and batch process control in the life science industry with validation experience is a plus. Knowledge of 21 CFR Part 11 requirements is a plus.

Would like to discuss about a job opportunity for the position "Engineer - Design & Development (EV Powertrain) for a Reputed Indian MNC @ Manali, Chennai Roles & Responsibilities: Should have experience in Design & Development of EV Powertrain, Proto type development, Troubleshooting & Validation of EV Systems Must be familiar with Motor Specifications such as torque, speed, efficiency, thermal management & motor controller Technical Documentation: Creating detailed documentation for designs, test results, user manuals, and maintenance guides Good knowledge in software tools like MATLAB/Simulink, Vector CAN analyzer, Bus master software, controller software flashing & Python coding for data analysis Desirable Candidates: Engineering graduate with 3+ years of experience in design & development of EV powertrain, preferably from Automotive Industry Share your updated CV, if interested Contact Person: Ms John blessy Executive Talent Search 9047088211 johnblessy.l@haarvard.com

Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences

5 to 10 years of experience Experience using virtual prototyping tools such as Synopsys Virtualizer, Synopsys VDK ,Cadence Protium, or similar. Experience in testing and validating embedded systems functionality using virtual prototypes. Strong communication skills to work collaboratively with software teams and share functional validation insights. Familiarity with basic test case development and execution for hardware/software integration. Experience in debugging and troubleshooting hardware systems in a virtualized environment. Strong understanding of embedded systems, firmware development, and system-on-chip (SoC) architecture. Proficiency in programming languages such as C or Python for testing and automation. Strong communication skills for effective collaboration with cross-functional teams. Areas of Responsibility : Use Synopsys Virtualizer or similar virtual prototyping tools to test and validate the basic functionality of hardware designs. Collaborate with the software team to share functional validation results, enabling them to align software development with hardware features. Provide valuable feedback and insights to software teams to guide the development of firmware and drivers. Develop and execute basic test cases to ensure the functional integrity of the virtual prototype. Perform system-level simulations and debugging using virtual prototypes, ensuring accurate and early-stage verification. Create reports documenting test results, issues found, and potential areas for optimization. Assist in integrating software with the virtual prototype for more advanced testing and validation as needed. Support software engineers by providing necessary hardware context for system integration and debugging.

General Summary: Bachelors /Masters degree in Engineering Relevant experience of 6+yrs in any of the mentioned domain - Verification/ Emulation/ Validation Verification: Strong knowledge of digital design and SOC architecture. Good understanding of OOP concepts Experience in HVL such as System Verilog, UVM/OVM & System C Experience in HDL such as Verilog Knowledge of ARM/DSP CPU architecture, High Speed Peripherals like USB2/3, PCIE or Audio/Multimedia Familiarity with Power-aware Verification, GLS, Test vector generation is a plus Exposure to Version managers like Clearcase/perforce FPGA Emulation : Familiarity with Verilog/Vhdl and General Digital Logic Design concepts Knowledge of system-level architecture including buses like ARM processor bringup, AXI/AHB, bridges, memory controllers such as DDR/Nand. Knowledge of peripheral emulation like PCIE/USB is a plus. Strong working knowledge of UNIX environment and scripting languages such as Perl or shell Working knowledge XILINX Virtex FPGA architecture and experience with ISE tool flow Pre/Post silicon Validation: ARM based System-On-Chip Pre-Silicon emulation and Post-Silicon ASIC Validation experience related to board bring up and debug. Perform system level validation and debug Debug experience with Lauterbach Trace32 environment. Test equipment like Logic analyzer, Oscilloscope and Protocol analyzers. Embedded software development of low level hardware drivers in C language. Working experience related to one or more of the following is required. ARM/DSP Processors/USB/PCIE, Ethernet Minimum Qualifications: Bachelor's degree in Computer Science, Electrical/Electronics Engineering, Engineering, or related field and 3+ years of Hardware Engineering or related work experience. OR Master's degree in Computer Science, Electrical/Electronics Engineering, Engineering, or related field and 2+ years of Hardware Engineering or related work experience. OR PhD in Computer Science, Electrical/Electronics Engineering, Engineering, or related field and 1+ year of Hardware Engineering or related work experience.

API -QA

Hiring for QA skills #Validatation #Equipments Location - Derabasssi, Punjab Exp. - 3yrs - 6yrs Preffered - API Plant Only Salary - Max. 6LPA Intrested canidates share resume on 9815675900 meenakshikandpal@tdsjobs.com

Roles and Responsibilities Conduct quality control tests on raw materials, intermediates, and finished products using techniques such as HPLC, GC, FP, IP, Stability studies. Ensure compliance with cGMP guidelines and maintain accurate records of testing results. Investigate market complaints and perform microbiological analysis to identify root causes. Develop and implement quality assurance procedures for OSD formulations. Collaborate with cross-functional teams to resolve issues related to dissolution testing.

About this role: Wells Fargo is seeking a Independent Testing Specialist. In this role, you will: Participate in less complex development and design of methodologies and standards for review activities companywide in alignment with the risk management framework Ensure effective and appropriate testing, validation, and documentation of review activities for risk programs, risks, and controls according to standards and other applicable policies within Independent Testing Support and implement less complex initiatives with low to moderate risk and exercise independent judgment to guide risk reporting, escalation, and resolution Present recommendations for resolving more complex situations and exercise independent judgment while developing expertise in risk management framework and the risk and control environment Collaborate and consult with colleagues, internal partners and management Required Qualifications: 2+ years of Independent Testing experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.

Key Responsibilities: Oversight of Quality Control activities related to Raw Materials and Packing Materials . Supervision & review of analytical data, documentation & compliance for material release. Handling of Quality Management System (QMS) elements including OOS, OOT, deviations, CAPA, and change controls . Coordination with cross-functional teams for timely review and resolution of quality issues. Ensuring regulatory compliance as per current GMP standards. Leading audits, facing regulatory inspections, and supporting continual improvement initiatives. Candidate Profile: B. Pharm / M. Pharm / M.Sc. with 15 - 20 years of relevant experience in the pharmaceutical industry. Strong exposure to quality control of raw and packing materials in regulated environments. Hands-on experience in QMS implementation and review processes . Excellent documentation, communication, and leadership skills. Must be willing to relocate to Mysore, Karnataka .

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10 - 15 yrs. with dossier filling experience in MEXICO Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Should have through knowledge of Mexico submission. Should have understanding for requirements of Mexico. Should have understanding for review of regulatory documents like batch record, specifications, COAs, stability data, change control, process validation report etc. Should have knowledge of review of method validations, chromatograms, dissolution profile, raw data etc. Interested candidate can share cv on creyesha.macwan@alembic.co.in

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.

Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standards. Facilitate the retrieval of technical documentation Collaborate with subject matter experts to review and validate technical documents Ensure that all technical documentation adheres to regulatory and quality standards.

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products

External Job Description Job title: Qualification & Validation Expert, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Apply and align documentation standards with global quality team. Ensure that qualification reports and activities adhere to all applicable quality regulations and pharmaceutical practices. Validate that qualification activities meet health-related requirements, including safety and environmental standards. Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices. Provide training and support to team members on compliance-related topics and best practices. About you: Experience: >5 years professional experience in qualification Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point Education: Bachelors degree in engineering, Pharmacy, Chemistry, or a related field. Advanced degree (e.g., MSc, PhD) preferred Languages: Excellent English communication and writing, French or other Languages in addition preferred.

Qualification & Validation Specialist, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Include references to relevant documents essential for the qualification process. Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and update. Schedule formal consolidated review and approval meetings for qualification protocols Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met. Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities Ensure all documentation complies with overall documentation standards. Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes About you: Experience: Professional experience in general documentation and project management. Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Technical skills: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point. Education: Bachelors degree in business administration, life sciences, or a related field. Languages: Excellent English communication and writing, French or other Languages in addition preferred

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.

Note * Please mention the required skill sets in your resume ,if you have the experience in the skills. Key Requirements: MCAL Driver Expertise : Strong Experience with drivers like MCU, PWM, GPT, WDG, ADC, DIO, PORT, MEM, SPI, UART, CDD; SWC Creation and Development; BSW Configuration DaVinci Configurator : Proficient in using DaVinci Configurator and Developer tools. Automation of DaVinci Configurator with Groovy Scripting. Good in Embedded C Programming SWS Documents: Strong understanding and implementation skills of MCAL. API & Configuration: Strong understanding of MCAL various APIs and configuration parameters.

In this role, you will: Lead or participate in moderate to high risk or complex review activities in a matrixed environment and communicate emerging risks to management within Independent Testing Contribute to large scale planning related to Independent Testing deliverables Review and research moderately complex potential corrective actions, and follow through on reporting, escalation, and resolution Ensure effective and appropriate testing, validation, and documentation of review activities for risk programs and controls according to standards and other applicable policies Resolve moderately complex issues and lead team to meet Independent Testing deliverables while leveraging solid understanding of risk management framework and the risk and control environment Collaborate and consult with colleagues, internal partners, management and lines of business regarding risk management Required Qualifications: 4+ years of Independent Testing experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education Desired Qualifications: Strong Excel and Power point skills Should have good exposure in Compliance and Risk Job Expectations: Work timings would be 1:30 PM to 10:30 PM 11 May 2025 Wells Fargo maintains a drug free workplace. Please see our to learn more.

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Validation Associate Bangalore (Job Code # 173) b) For Position in Ahmedabad Search : Validation Associate Ahmedabad (Job Code # 175)

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.