4 Customer Requirements Jobs

Candidate From ValVe Industry Review customer specification and inputs /resolve issues if approve. Conversion of Customer Requirements to Factory Products Management for the complete team, Design calculation and seek approval from statutory bodies if Role: Head - Design & Development Industry Type: Industrial Equipment / Machinery Department: Research & Development Employment Type: Full Time, Permanent Role Category: Engineering & Manufacturing Education PG: PG Diploma in Mechanical, M.Tech in Mechanical, MS/M.Sc(Science) in Mechanical Engineering Doctorate: Ph.D/Doctorate in Mechanical

Key responsibilities include: Responsible for all Regulatory related activities includes Filing, Submission, responding to DCGI queries, Customer requirements, SUGAM portal registrations, Renewal of licenses, IP commission & CDTL requirements, etc. Responsible to get approvals for the submissions to CDSCO like New drug application, FDC application, Subsequent new drug application, Import license, Test license, etc. Responsible for FSSAI annual returns filing, FosCos online license modification. Responsible for handling PV related activities, which includes PSUR submission and reporting the adverse events of pharmaceutical products for case processing, reviewing & submitting the reports to regulatory authorities. Filing & Submissions: Responsible to prepare submissions to CDSCO like New drug application, Subsequent new drug application, etc. and ensures to respond the DCGI queries & SEC recommendations in timely manner to get permissions/approvals. Responsible to collect & review all the essential documents (API vendor documents, CMC documents, Administrative part, Clinical & Non-clinical data) from CFT for submission. Managing the queries raised by CDSCO against the submitted applications and responsible for addressing the queries & requirements from Indian Pharmacopeia Commission, Central/State Testing Laboratories, SEC committee, DCGI, CDSCO. Regulatory Compliance Management Supports in customer / regulatory complaints, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Ensures that customer / regulatory complaints are adequately handled, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Evaluates, reviews and approves product claim on labels and marketing collaterals in accordance to legal and regulatory requirements. Responsible to organize and archive all regulatory documents including NOC, Product license, NSQs data, AE reports, Drug office requests by co-ordination with site Co-ordinate with the Consultants and Customers on regulatory requirements for new products and major changes in existing products. Reviews proposed changes and its supportive information for completeness and accuracy while ensuring compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO) Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA notification as necessary within all relevant regulatory matters Pharmacovigilance Management Responsible for submission of Periodic Safety Update Reports (PSUR) to regulatory authority as a part of new product approval/regularization within stipulated timeline. Responsible for reporting the Adverse Event PV, follow up, coordination with site QA (in case of quality complaint) and provide investigation report to customers and getting the concurrence / approval from customer on investigation and closure. Co-ordinate with CRO for processing AE cases & responsible for reviewing and submitting the reports to regulatory authorities on time. Assisting in PV projects in compliance with customer agreement and local & global regulatory guidelines. Maintain and track all CAPAs & submitted reports related to pharmacovigilance. Ensure pharmacovigilance regulatory compliance with oversight, as needed. FSSAI (Food Safety & Standards Authority of India) To perform & ensures on-time FSSAI annual returns filing (Form ‘D’) periodically. Responsible for central FSSAI license modification by including addition of products time to time and other licensing activities like Free Sale Certificate. Ensures regulatory compliance related to registration of Food Business Operator through Food Safety Compliance System (FoSCoS), Food safety audit, etc. Quality management (NSQ): Co-ordinates with site team & ensure to fulfil the drugs control requirements (Documents/ Sample) of concern FDA/DCD/DTL by responding within stipulated timeline. Collaborate & Coordinate with internal team to make a strategic plan to respond the NSQ/Showcause cases.

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Job Title: Software Engineer Location: Bangalore Experience: 46 Years in Embedded Aerospace Software Standards: DO-178C Job Summary This is a contract role for a Software Engineer working in the aerospace domain , focused on embedded software development and testing . You will be responsible for ensuring software is developed according to DO-178C safety-critical guidelines. You will work closely with both hardware and systems engineering teams and contribute throughout the software development lifecycle , especially focused on verification and certification . Key Responsibilities – Explained Requirement and Architecture Collaboration Work with Hardware/System Architects to define: Customer Requirements HW-SW Interface Specifications Make sure the software aligns with the hardware and system requirements . Code and Document Reviews Review of artifacts : Software Source Code High-Level & Low-Level Requirements Ensure code and documents follow aerospace standards and guidelines like DO-178C . Test Procedure Development Develop and review: High-level Test Procedures (HLTP) – which define how to test high-level requirements. Test Cases – specific conditions or inputs used to verify proper functionality. Traceability Matrices – documents that link: System Requirements Software Requirements Code Tests. Tool Usage DOORS : Requirements management tool; used for updating and reviewing traceability. PVCS : Version and configuration control system – tracks changes in documents, code, and test results. Mantis Bug Tracker : For logging and closing defect reports. Test Execution and Debugging Execute HLTPs and record results. Use tools like: Logic Analyzers Oscilloscopes DMMs (Digital Multimeters) Debug issues using both Black Box (external functionality) and White Box (internal code structure) testing techniques. Certification & Compliance Documentation Create and review: Software Verification Reports Coverage Analysis Reports SCI (Software Configuration Index) SAS (Software Accomplishment Summary) – critical for DO-178C certification. Mandatory Skills – Explained Educational Qualification Bachelor’s degree in Electronics or Computer Science Engineering . Embedded Aerospace Experience 4–6 years working on safety-critical software for avionics systems. DO-178C Expertise Understand and implement certifiable software development processes . Testing Knowledge Strong in Requirement-Based Testing (RBT). Able to perform Integration Testing , High-level Testing , and Debug Testing . Hardware Interaction Experience with hardware debugging tools like: Oscilloscopes DMMs Logic Analyzers Tool Knowledge DOORS – Requirements traceability. PVCS – Source/configuration control. Mantis – Bug tracking. Communication Must be able to document and communicate findings and test results effectively. Preferred Skills (Nice to Have) Development Tools: IAR , CCS (Code Composer Studio) – popular IDEs for embedded development. Code Coverage Tools: RTRT , HCL DevOps – tools for structural code coverage (used in DO-178C verification). Programming Skills: Strong proficiency in C Programming – foundational for embedded systems. Processor Experience: Knowledge of microcontrollers like ARM Cortex , Microchip PIC , TI DSP , STM32 . Peripheral Interfaces: I2C, SPI, UART, ADC, DAC – required for low-level driver development. Full-Cycle Project Exposure: End-to-end experience in an aerospace project lifecycle – from requirement gathering to certification. Lean Methodology: Exposure to lean/agile development practices – preferred in modern embedded teams.