360 Validation Jobs - Page 14

QC Lab Incharge, Medical Device mfg. Role ; manage QC Lab, For testing of medical devices / pharmaceuticals, Familiar with Lab mgmt system, Implementing GLP, ISO 17025 standards, Familiar with calibration, validation of equipment & documentation

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Liaising with customers, suppliers and research/scientific staff. Developing new analytical methods. Making sure that data is accurately recorded in accordance with guidelines. Reporting and presenting results. Preparing product licence documentation

Permanent Job Opportunity Pre & Post Silicon Validation Engineer | Bangalore:: Univision Technology Consulting Pvt. Ltd Position Details: Role: Permanent Position Company Name: Univision Technology Consulting Pvt. Ltd., Bangalore Website: https://univisiontechnocon.com Job Location: Bangalore About Us: UNIVISION enables technology through R&D, innovation, passion, and disruption in areas such as System Engineering, IoT, Automation, Cloud Computing, and Artificial Intelligence. We offer customer-centric and customized solutions across industry verticals including Semiconductors, Automotive, Cloud Computing, Consumer Electronics, and Automation Control Systems. Role: Pre & Post Silicon Validation Engineer Areas of Responsibility: Hands-on experience in complex silicon validation on emulation and pre & post-silicon platforms. In-depth knowledge of one or more peripheral protocols and specifications. Bare-metal/Linux driver and firmware development experience, with excellent C programming skills. Knowledge of any CPU architecture (ARM preferred). Platform/board-level debugging experience is an added advantage. Familiarity with lab equipment such as oscilloscopes, signal generators, protocol analyzers, and logic analyzers. Key Skills: Zebu, Palladium, FPGA, Ethernet, Flash IPs, PCIe SerDes, ARM Experience Required: 5 to 10 years Additional Skills and Experience: Testing and validating embedded systems functionality using virtual prototypes. Strong communication skills for effective collaboration with design teams and sharing validation insights. Basic test case development and execution for hardware/software integration in pre- and post-silicon phases. 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 for testing and automation. Collaborating with cross-functional teams for co-validation and early firmware support. Troubleshooting using logs, simulations, and virtualization tools.

Role & responsibilities We are actively looking for highly experienced Emulation Engineers to join our team in Bangalore. If you have over 6+ years of experience in FPGA(HAPS) / Synopsys(ZEBU) with expertise in: Emulation and Prototyping technologies such as Palladium, Veloce, Zebu, HAPS, (these names are registered trade marks of their respective owners)Developing emulation testbenches to support necessary Design Verification scenarios and firmware/software/hardware bring up Build emulation models from RTL and release/support those models Develop emulation tools such as debugger and monitor features Work closely with verification and software development teams Develop emulation and verification strategy Develop test framework and test cases Write documents such as verification specification and reports Preferred candidate profile Bachelors/Master’s degree or higher in EEE/ECE 6 to 12 years or more of practical semiconductor Emulation and Prototyping technologies such as Palladium, Veloce, Zebu, HAPS, (these names are registered trade marks of their respective owners) Experience with one or more of the emulation platforms like HAPS, Zebu, Palladium, or Veloce Experience in FPGA prototyping, with programming experience in C/C++, Verilog, Python, shell scripting. Prototyping / ProtoCompiler and Vivado expert added advantage. Experience with emulation model development and bring up Experience with developing new transactors and hybrid emulation model development Computer architecture knowledge, especially in CPU and standard bus protocols Excellent verbal and written communication skills

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, define, analyze, and document testable business requirements, collaborating closely with customers, end users, and the IT team. Leverage good communication and analytical skills, business relationships, and business process expertise to understand, document, assess, and drive business change needs to accelerate process improvement and business growth. Drives re-use of existing solution capability or introduction of new technology to achieve program or project objectives Works independently and simultaneously on multiple projects with various domain experts to understand current business process landscape, enterprise alignment, and growth. Business Analysis ownership for [functional processes], Identify and evaluate potential solutions, favouring existing invest application estate. Prepares cases which define potential benefits, options for achieving these benefits through development of new or changed processes, and associated business risks. Measurably improve business process capability and performance indicators for delivered projects Attain a high re-use of technology while driving process standardization for owned processes Drives effective requirements' definition that creates objective, testable requirements that results in a business solution which meets or exceeds the defined objectives. Create functional requirements in Use Cases. Coordinate requirements walk-through and signoffs, verifying with collaborators that Use Cases and process models accurately portray specific business needs. Recommends options that best fit the business needs, value proposition and strategic roadmap. Identifies, analyses, and fixes the root cause of business and technical issues. What will you need to be successful? Education: Bachelors or masters degree in computer science, information systems, business administration, or other related field, or equivalent work experience. Experience : Minimum 5-7 years of relevant technical or business work experience . With at least 3 years of experience in information technology & regulatory affairs . Certification in business analysis is preferred. Proven Experience with Rimsys and PTC Windchill (PLM systems) Solid experience working within GxP-regulated environments , including validation of systems, Quality Systems, and compliance with regulatory standards Business process design and reengineering techniques and methods. Business analysis: takes responsibility for investigative work to determine business requirements and specify effective business processes through improvements in information systems, information management, practices, procedures, and organizational change. Selects and embraces suitable business analysis methods, tools, and techniques, selecting the appropriate approach from predictive (plan driven) or adaptive methods (iterative/agile). Collaborates with partners at all levels in the conduct of investigations for strategy studies, business requirements specifications, and feasibility studies. Designs and manages tests of new/updated processes. Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to partners, and are available for specification of user instructions. Highlights issues and risks identified during testing to business customers. Defines and manages prioritizing, requirements definition, and prioritization activities for initiatives of medium size and complexity. Facilitates input from customers, provides constructive challenge, and enables effective prioritization of requirements. You Unlimited. We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance. Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave. Your Wellbeing: Parents/Parents in Laws Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave. Flexibility : Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Skill required: Financial Planning & Analysis - Financial Planning and Analysis (FP&A) Designation: Financial Plan & Analysis Assoc Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years About Accenture What would you do You will be aligned with our Finance Operations vertical and will be helping us in determining financial outcomes by collecting operational data/reports, whilst conducting analysis and reconciling transactions. Preparation of standard & Adhoc management reports for region, country, product, Service typeetc. Provides standardized and insightful level of analyses is provided. Delivers ad hoc analyses.Supports Annual Operating Plan & forecasts Planning, Creating and managing reporting data and report out from various database systems.Provide professional expertise and direction to other team members and act as the focal point forbusiness units and Technology by participating in key project initiatives. Also, as required, manageclient communication, responding to queries, investigate irregularities and anomalies and providetechnical support for daily task.Financial planning, reporting, variance analysis, budgeting and forecasting Partners with reporting clients to understand their strategic goals, operational context and activitiesin order to explain results with strategic business insights and facts Use a diverse range of applications and understand the business and technical functionality ofeach application and its relevance to the business community. Provide support to all business units across the region, including product understanding, validation,problem/query resolution and coordination of communications. Uses storytelling principles to convey impactful messagesMajor accountability for Planning, Forecasting, Preparation & analysis of P&L, Forecast accuracy, SG&A,Working Capital Cost of Sales reports is to support the businesses.Financial planning and analysis (FP&A) refers to the processes designed to help organizations accurately plan, forecast, and budget to support the company s major business decisions and future financial health. These processes include planning, budgeting, forecasting, scenario modeling, and performance reporting. Team & individual objectives and performance in line with culture. Services maintained in line with Service expectations agreed with the business.Pro-active participation in the Information Delivery leadership team. Development, Objectives and Performance management of the team and individuals in line with policy and performance framework. Ensure one on one feedback is held with all team members. Reduction of single points of failure and dependency on key individuals. Establish action plans in relation to Staff Satisfaction feedback What are we looking for Ensure a robust environment which supports agreed customer service levels. Extensive use of Financial and Management applications which support financial and Management Information analysis. Build the capabilities of the team to grow the level of competency across technical and business environments in line with strategic information delivery direction Work with Engagement Partners to align information delivery approach and service levels with business priorities and direction, maximizing the relevance and value of the information service to the achievement of business objectives In co-operation with other units, ensure processes are in place to assist and educate customers and other FI&IM teams in understanding outputs of applications/models under the control of the area Embrace a team-based leadership style, building trust and co-operation within the team and across other teams within Finance and the business Drive an end to end view of information service delivery across MI and FI environments, working with content management, Systems Control and Information Delivery on data inputs, business rules and ensuring quality outputs Embed common, simplified and documented processes within the team and across FI&IM to reduc Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 171 b) To Apply for above Job Role ( Pune ) Type : Job Code # 172 c) To Apply for above Job Role ( Indore ) Type : Job Code # 174

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 .

Dear Respect Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation QA Department Job description -4 -7 Yrs Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs,BDRs, PDRs, MFRs and MPR) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Please Share update resume: careers@biophore.com Ref to Friends or colleagues. Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

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

Roles and Responsibilities: Responsible for capturing additional detail information needed for the testing the backend APIs and integration points Responsible for the documentation of test scenarios, deployment of builds in lower environments on AWS Participates in estimation and planning of Testing, validations, deployment and operation activities. Responsible for effort estimation of overall testing activities for all software units based on provided functional specification Responsible for working closely with developers and business analysts. Tools Required: Performance tools - JMeter, Gatling, scala Version control knowledge - Git - Subversion Continuous integration experience - Jenkins Experience & Skills: Testing - Experience and a strong interest in system testing - Junit/TestNG - XPath - RestAssured - mock framework Request response (Must have) - Message Queue REST Certifications (Good to have): • ISTQB Foundation or similar