360 Validation Jobs - Page 10

As an Assistant Manager/Deputy Manager specializing in solar products at our client, a leading name in Electrical Equipment Manufacturing, you will play a crucial role in the design, development, and optimization of solar product solutions for solar photovoltaic (PV) systems. Your primary responsibility will be to lead the process of ensuring the reliability, efficiency, and performance of solar products, thereby contributing to the advancement of renewable energy technologies. You will work collaboratively with cross-functional teams to achieve these objectives. In the realm of Design and Development, you will be at the forefront of leading the conceptualization, design, and development of products, taking into account various factors such as electrical performance, thermal management, durability, and manufacturability. Using CAD software and simulation tools, you will model and analyze product designs to optimize for efficiency and reliability. Keeping abreast of industry trends and emerging technologies will be vital to integrating innovative features into the solar products. Your role will also involve Testing and Validation, where you will develop test plans and procedures to evaluate the electrical and mechanical performance of the products under different operating conditions. Collaborating with testing teams, you will conduct validation tests and analyze results to ensure compliance with industry standards and project requirements. Based on test findings, you will identify areas for improvement and implement design modifications accordingly. Manufacturing Support will be another key aspect of your role, as you will closely engage with manufacturing partners to facilitate a seamless transition from design to production. Providing technical guidance and resolving any design-related issues will be essential in this phase. Furthermore, you will optimize manufacturing processes to enhance efficiency, reduce costs, and improve quality control measures, while also conducting regular audits and inspections to uphold consistency in production and performance. Cross-functional Collaboration will be integral to your job, as you will work in tandem with internal teams such as electrical engineering, mechanical engineering, and product management to align product design with overall system requirements and project goals. Additionally, you will liaise with external stakeholders like suppliers and customers to gather feedback, address concerns, and incorporate requirements into the product designs. Documentation and Compliance will also fall within your purview, where you will prepare technical documentation including design specifications, test reports, and installation guidelines to support product development and deployment. Ensuring compliance with relevant industry standards, regulatory requirements, and safety guidelines in the design and manufacturing of solar products will be a critical aspect of your responsibilities. Staying informed about changes in regulations and standards and updating designs and processes accordingly will be essential to maintain compliance. If you are passionate about making a career in the leading Electrical Equipment Manufacturing domain and possess the required experience and qualifications, we encourage you to apply for this exciting opportunity. Our client offers a competitive salary package and a stimulating work environment with ample opportunities for growth and development. To apply, please send your resume to prasiddhi@namanstaffing.com. We look forward to receiving your application soon!,

As a valued member of our team, you will be responsible for carrying out the duties and responsibilities associated with this position. The job description content for job profiles is currently being updated, and we are working diligently to finalize this requisition for posting. If you require more information to complete this process, please do not hesitate to reach out to us at mydanahrplatform@dana.com. Your role will involve performing various job duties and responsibilities that are essential to the successful execution of this position. We are constantly striving to enhance our job profiles and ensure that they accurately reflect the requirements and expectations associated with each role within our organization. If you have any questions or need further clarification on any aspect of this job description, please feel free to contact us. Thank you for your interest in this opportunity. We look forward to potentially working together to achieve our mutual goals and objectives.,

Key Responsibilities : Test Case Development : Create, maintain, and execute detailed test plans, test cases, and test scripts based on project requirements and specifications. Manual Testing : Perform functional, regression, integration, usability, and exploratory testing to identify software defects. Bug Reporting : Identify, document, and track defects using bug-tracking tools (e.g., Jira, Bugzilla) with clear steps to reproduce and severity assessments. Requirement Analysis : Review and analyze project requirements, user stories, and design documents to ensure testability and alignment with business goals. Collaboration : Work closely with developers, product managers, and other QA team members to clarify requirements and ensure timely resolution of issues. Test Environment Setup : Prepare and configure test environments, including test data and system settings, to simulate real-world scenarios. Validation : Verify bug fixes and ensure they meet quality standards before release. Documentation : Maintain accurate documentation of test results, processes, and methodologies. Skills and Qualifications: Experience : 1-3 years of experience in manual software testing or a related role. Technical Skills : Familiarity with software testing methodologies (e.g., black-box, white-box, regression testing). Knowledge of bug-tracking tools (e.g., Jira, Trello, Bugzilla) and test management tools (e.g., TestRail, Zephyr). Understanding of software development life cycle (SDLC) and agile methodologies. Optional : Familiarity with basic automation concepts or tools (e.g., Selenium, Postman) is a plus but not mandatory.

We are seeking an experienced and skilled CSSD Product Engineer to join our team. The successful candidate will be responsible for developing, and implementing sterile packaging and processing solutions for medical devices and equipment. The CSSD Product Engineer will play a critical role in ensuring the safety, quality, and efficacy of our products. Key Responsibilities: 1. Product Testing and Validation : Conduct testing and validation of sterile packaging and processing solutions to ensure they meet design specifications, regulatory requirements, and industry standards. 2. Process Improvement : Continuously evaluate and improve sterile packaging and processing solutions, implementing changes as needed to ensure optimal safety, quality, and efficacy. 3. Regulatory Compliance : Ensure compliance with regulatory requirements, such as FDA, ISO, and CE marking, for sterile packaging and processing solutions. 4. Collaboration and Communication*: Collaborate with cross-functional teams, including R&D, manufacturing, and quality, to ensure effective communication and coordination of product development and launch activities. 5. Technical Support : Provide technical support and guidance to internal stakeholders, including manufacturing, quality, and customer service, on sterile packaging and processing solutions. 6. Industry Trends and Standards : Stay up-to-date on industry trends, standards, and regulatory requirements, applying this knowledge to inform design and development activities. 7. Documentation and Record-Keeping : Maintain accurate and complete documentation and records of design and development activities, testing and validation results, and regulatory compliance. Requirements: - Bachelor's degree or Diploma in Engineering (e.g., Mechanical, Biomedical, Packaging), or related field. - Minimum 1-5 years of experience in product or a related field, preferably in the medical device industry. - Strong knowledge of sterile packaging and processing solutions, development, testing, and validation. - Experience with regulatory requirements, such as FDA, ISO, and CE marking. - Excellent problem-solving, communication, and collaboration skills. - Ability to work in a fast-paced environment and prioritize multiple projects simultaneously.,

About the Role You will be based on-site at our Sourcing Center in Bangalore, providing recruitment solutions across various roles and locations in India. As a vital member of the high performing team, your responsibility will be delivering services through an innovative recruitment model. This involves engaging with key stakeholders and collaborating with our nearshore Sourcing Center colleagues to identify the best candidates for the organization. You will also assist and guide hiring managers in sourcing, onboarding, and managing candidates for job requisitions. Your role will include sourcing candidates through different channels, maintaining strong candidate relationships, and providing market insights to the team and clients. Additionally, you will support the candidate onboarding process and contribute to the continuous improvement and development of services for one of Hay Enterprise Solutions" major accounts. This position offers an excellent opportunity to be a part of the dynamic HES community, enhance your skills, and work with a high achieving and collaborative team. Eligibility Criteria - A Graduate in BSc Electronics (highly preferred) - 3 to 6 years of relevant experience in VLSI skills such as Design, Verification, and Validation - Proficient in Recruitment within the Semiconductor industry - Strong communication, time management, and negotiation skills.,

As a Senior Executive/Assistant Manager, you will play a crucial role in supporting the management team to drive operational excellence and enhance overall organizational effectiveness. Your responsibilities will include coordinating daily operations to ensure efficiency and productivity, supervising team members, managing project timelines, and allocating resources effectively. You will also be responsible for documentation management, quality review processes, and ensuring compliance with company policies and industry regulations. In this role, you will act as a liaison between various departments, facilitating communication and collaboration to achieve strategic goals. You will contribute to the development and implementation of innovative strategies that optimize productivity and improve service delivery. Additionally, you will assist senior management in strategic planning and decision-making, prepare and present regular reports on project status and departmental performance, and collaborate with other departments to achieve organizational goals. To excel in this position, you should have a Master's degree in business administration, management, or a related field, along with 3-5 years of experience in a similar position. You should have a proven track record of managing teams effectively, strong understanding of project management methodologies, and excellent verbal and written communication skills. Proficiency in Microsoft Office Suite and project management software is required, along with the ability to analyze data and make informed decisions. Strong organizational and multitasking skills, experience in budgeting and financial management, and the ability to conduct market research and analysis are essential for this role. Demonstrated leadership abilities, team-building skills, and knowledge of industry trends and best practices are also important. Professional certifications in management or project management would be a plus. If you are a detail-oriented individual with a commitment to quality, strong interpersonal skills, and the ability to work collaboratively in a fast-paced environment, we encourage you to apply for this position. Join us in building a cohesive and high-performing team that can adapt to the ever-changing landscape of the industry.,

As a qualified candidate with a BTech degree in Computer Science or Electronics & Communication and 1 to 2 years of experience, you will be responsible for the following key tasks: Product Inspection & Testing: - You will be required to perform validation and verification testing to ensure the consistency of products. - Investigate and effectively resolve any quality issues or defects that may arise during the testing process. - Maintain detailed test records and generate quality reports to track and communicate the outcomes of the testing procedures. - Analyze the root causes of quality failures and implement appropriate corrective actions to address them effectively. Customer Complaint Handling & CAPA (Corrective and Preventive Actions): - Conduct thorough investigations into customer complaints and non-conformance issues to identify areas of improvement. - Develop and implement CAPA processes to proactively address and prevent recurring quality issues, ensuring continuous enhancement of product quality. - Collaborate closely with cross-functional teams to enhance customer satisfaction levels by addressing feedback and implementing necessary improvements. Your role will be crucial in ensuring the quality and consistency of products through meticulous testing procedures and efficient handling of customer complaints, ultimately contributing to the overall success and reputation of the organization.,

You should have knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. It is essential to collaborate effectively with developers and stakeholders to proactively understand and analyze the application requirements. Your responsibility will include creating comprehensive test cases and scenarios based on risk-based approaches, with a specific focus on critical functionalities and compliance aspects of the application. You must ensure that the test cases are traceable to the system requirements and risk assessments. Additionally, you will be required to execute IQ/OQ/PQ to validate the application. It will also be your duty to log, track, and manage defects identified during testing using test management tools. Furthermore, you will need to prepare validation documentation, which includes test scripts, validation protocols, and summary reports. The role requires the ability to work both independently and as part of a team, with a strong emphasis on quality and attention to detail.,

Opening for an Pharma Compay. Location : Bhiwadi. Job Description: Hands-on experience in QA documentation Qualification and validation activities QMS (Quality Management System) activities Interested candidates shared resume on snehal@topgear@gmail.com

Role & responsibilities Good Knowledge in Vehicle features of Passenger cars (ex: RAM truck, JEEP, etc). Good Knowledge in Validation Methodologies & Architecture such as V-Model, Agile, etc. Good experience in Functional & Diagnostics Validation for Vehicle features on HIL - Test Properties. Good experience in Testcase development - Manual & Automation method for Vehicle features on HIL - Test Properties. Sound knowledge and hands on with HIL (Hardware in Loop) system hardware and testing tools such as dSPACE. Experience in communication protocols such as CAN, LIN, UDS and Diagnostics Protocols/Standards. Test Automation Experience using tools such as Automation desk, Python. Hands-on experience in HIL Testing tools such as Control desk, Vector CANoe. Strong in problem solving skills. Clear and concise spoken and written communication skills. Ability to learn/adapt to new HIL environment & tools. Automotive Testing experience

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys delivery team your primary role would be to ensure effective Design Development Validation and Support activities to assure that our clients are satisfied with the high levels of service in the technology domain You will gather the requirements and specifications to understand the client requirements in a detailed manner and translate the same into system requirements You will play a key role in the overall estimation of work requirements to provide the right information on project estimations to Technology Leads and Project Managers You would be a key contributor to building efficient programs systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: 3 years of experience in Oracle EBS development and implementation Strong expertise in Oracle EBS Technologies Forms Reports Workflow SQL Loader Oracle Applications APIs Database concepts PL SQL Unix Shell Scripts Oracle Database Upgrade 9i to 11g Data mapping conversions interfaces and validation Oracle R12 data models and SQL queries preferably using TOAD Good understanding of SDLC and agile methodologies Software development principles Performance engineering and quality processes Additional Responsibilities: Knowledge of design principles and fundamentals of architecture Understanding of performance engineering Knowledge of quality processes and estimation techniques Basic understanding of project domain Ability to translate functional nonfunctional requirements to systems requirements Ability to design and code complex programs Ability to write test cases and scenarios based on the specifications Good understanding of SDLC and agile methodologies Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Preferred Skills: Technology->Oracle eBS Technical->Oracle Application Development

In-depth knowledge of Transmission, Engine Experience of tools like INCA/ VISU/Canoe, Matlab, ETAS tools Knowledge of vehicle integration, vehicle level functions, usage of PC, automation tool CAN protocols, UDS services, IVN, ECU, TCU , diagnostics Required Candidate profile Candidates must have experience in R&D of Calibration (Engine & Transmission/ Powertrain) for IC Engine, Gasoline, LPG, Petrol, CNG engines Min experience 4+ Yrs in relevant Industry

AUTOMOTIVE EMBEDDED TECHNOLOGY PRODUCT LIKE: ECU, TCU, CONTROLLES, ON/OFF BOARD CHARGER. ANALOG, DIGITAL, MCU, SENSORS, POWER, SUPPLIERS AND POWER AND POWER ELCTRONICS. HARDWAREAND SOFTWARE REQUIREMENT UNDERSTANDING AND PRODUCT ARCHITECTURE. Required Candidate profile PLAN, DEVELOPED AND PERFORM TESTING ON THE BENCH VEHICLES IN ALIGNMENT EMI/EMC I/O TESTING, DVP TESTING. ACCOUNTABLE FOR RFQ HANDLE & CONVERSION, VA/VE CONTINUOUS APPROACH. DEVELOP NEW FUNCTION MODULE

RESPONSABILITIES Understand system functionalities and related software requirements related to the products. Develop C/C++ code according to SW requirements. Debug and fix issues raised by validation teams. Knowledgeable about CI/CD development process and tools. Should be proficient in C and C++ and possess detailed knowledge of microcontroller protocols. Work closely with a multi-disciplinary team (system, hardware, algorithms, scientific researcher) to ensure software development coherence vs. global product development. Development, integration and testing of embedded software components. Perform software unit testing, integration and qualification testing where required. Development and integration of software components on standard or internal platforms. Debug raised issues and proposes fixes by discussing with testers and SW requirement engineers. Develop SW according to automotive standards (autosar) with knowledge about safety, cybersecurity, A-Spice. Contributes to appropriate procedures and documentation and capitalizes knowledge. Actively build, extend and maintain internal software library. Library covers generic software components, which are widely re-using in customer projects. Actively support quote process for new lighting projects. Provide technical ideas how to be realized customer requirements and supporting review process. REQUIREMENTS University Degree in Electronic & Electrical Engineering, Computer Science or equivalent. Experience in development and integration embedded software applications preferably for automotive. Excellent programming skills in C and good scripting skills (e.g., Python, MATLAB, C# etc.). Experience with different microcontroller architectures and communication buses. Experience with MBD development for embedded targets (MATLAB/Simulink). Familiar with agile as well as traditional development methodologies (SCRUM, V-Model). Master automotive quality and safety standards (Automotive SPICE, ISO26262). Good logical reasoning and problem investigation/resolution. Knowledge on requirements management (DOORS, Codebeamer). Good understanding of the functional safety. Experience with JIRA, Confluence, GITLAB, GitHUb, Jenkins. Knowledge and experience on Vector Tools (CANape, CANoe, Canalyzer). Good capacity of listening and communication skills. Team spirit and able to work autonomously. Fluent English. Nice to have: Strong experience with AUTOSAR architecture, methodology and toolchain PERSONAL CHARACTERISTICS & BEHAVIOURS Good teamwork, coordination, and communication skills. Good interpersonal skills to interact with diverse teams and take decisions. Very good analysis skills. Good problem-solving skills. Effective oral and written communication skills Preferred candidate profile

Role & responsibilities Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities. Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities. Maintain qualification documentation, including risk/impact assessments and change-control records. Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification. Diagnose deviations in qualification processes and initiate CAPAs. Manage and update the Qualification Master Plan and requalification schedules. Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies). Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more Preferred candidate profile Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC). Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators). Strong understanding of equipment qualification, utility validation, and cleanroom classification. Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards. Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements. Excellent analytical and problem-solving skills, with a methodical attention to detail. Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

We are looking for skilled Automation Engineers with experience in pharmaceutical projects and hands-on involvement in DCS and PLC-based industrial automation systems . The ideal candidate should be familiar with various communication platforms , automation technologies , and GAMP protocols . Key Responsibilities: Execute and manage automation projects in pharmaceutical environments. Design, configure, and implement DCS systems for process automation. Work with industrial communication protocols (e.g., Modbus, Profibus, Ethernet/IP). Ensure compliance with GAMP guidelines and validation processes. Collaborate with cross-functional teams for project execution and documentation. Participate in FAT/SAT and provide technical support during commissioning. Desired Candidate Profile: Bachelors degree in Instrumentation, Electronics, or related engineering field. 4+ years of experience in pharmaceutical automation projects. Hands-on experience with DCS/PLC systems (e.g., Siemens, Rockwell, ABB). Familiarity with SCADA/HMI systems and GAMP protocols. Strong analytical and troubleshooting skills. Good communication and team collaboration abilities.

Job Overview Jon Role : Senior Manager-CAE Experience :20-25 Years Package : Best Package in the Industry Location :Chennai Education :Graduation / post-graduation in mechanical engineering from reputed engineering college Required Skill Set Role: Lead a team of engineers to support Automobile and Industrial Equipment & Heavy machinery customers in Meshing and virtual validation Regular connect with customer managers & understand their requirements and build a team for CAE Work with Account Sales Mangers (ASMs) in connecting with new customer managers and technical presentations to expand and acquire new customers in CAE domain Experiences: 20+ years of experience working with Industrial Equipment & Heavy machinery companies directly or thru any engineering service providers in the area of CAE. Working knowledge of both Automotive and Off-Highway products is preferred, but majorly in Offhighway / Heavy Machinery . Strong experience in Program management, engineering delivery and operational excellence Interested professionals can share their profile to padmini.m@in.experis.com

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys delivery team your primary role would be to interface with the client for quality assurance issue resolution and ensuring high customer satisfaction You will understand requirements create and review designs validate the architecture and ensure high levels of service offerings to clients in the technology domain You will participate in project estimation provide inputs for solution delivery conduct technical risk planning perform code reviews and unit test plan reviews You will lead and guide your teams towards developing optimized high quality code deliverables continual knowledge management and adherence to the organizational guidelines and processes You would be a key contributor to building efficient programs systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: 5 years of experience as a software developer focused on Oracle EBS development and implementation Expert level understanding of Oracle EBS Technologies Forms Reports Workflow SQL Loader Oracle Applications APIs Database concepts and optimization techniques PL SQL Unix Shell Scripts Oracle Database Upgrade 9i to 12c preferably Data mapping conversions interfaces and validation Strong understanding of EBS R12 data models across at least 2 modules Finance HR Supply Chain etc SQL queries including complex queries and use of TOAD Strong understanding of Software Development Life Cycle SDLC and agile methodologies Software development best practices and coding standards Design principles and architecture concepts Performance engineering and quality assurance processes Version control systems e g Git Additional Responsibilities: Knowledge of more than one technology Basics of Architecture and Design fundamentals Knowledge of Testing tools Knowledge of agile methodologies Understanding of Project life cycle activities on development and maintenance projects Understanding of one or more Estimation methodologies Knowledge of Quality processes Basics of business domain to understand the business requirements Analytical abilities Strong Technical Skills Good communication skills Good understanding of the technology and domain Ability to demonstrate a sound understanding of software quality assurance principles SOLID design principles and modelling methods Awareness of latest technologies and trends Excellent problem solving analytical and debugging skills Preferred Skills: Technology->Oracle eBS Technical->Oracle Application Development

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: Minimum 2 years of experience in Oracle Fusion HCM modules like Global HR Payroll Absence Benefits Compensation Talent Succession Planning Performance Management Profile Management Recruiting ELM Security in this case since requirement is for Payroll experience in Payroll and Security is a must Should have Knowledge of DFF Fusion Fast Formula Should be aware of Oracle Fusion HCM Co Existence and working on the same Must have experience in BI OTBI Reports Must be experienced in Development Configuration solutions evaluation Validation and deployment Should have high level familiarity of Oracle Fusion HCM Payroll tables Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining analyzing and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes identify improvement areas and suggest the technology solutions One or two industry domain knowledge Preferred Skills: Technology->Oracle Cloud->HCM Cloud Technical

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: Minimum 2 years of experience in Oracle Fusion HCM modules like Global HR Payroll Absence Benefits Compensation Talent Succession Planning Performance Management Profile Management Recruiting ELM Security in this case since requirement is for Payroll experience in Payroll and Security is a must Should have Knowledge of DFF Fusion Fast Formula Should be aware of Oracle Fusion HCM Co Existence and working on the same Must have experience in BI OTBI Reports Must be experienced in Development Configuration solutions evaluation Validation and deployment Should have high level familiarity of Oracle Fusion HCM Payroll tables Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining analyzing and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes identify improvement areas and suggest the technology solutions One or two industry domain knowledge Preferred Skills: Technology->Oracle Cloud->HCM Cloud Technical

JOB RESPONSIBILITIES : [A] Regulatory Compliance : 1. To co-ordinate with corporate regulatory department for submission of documents as part of filing of DMF, updating and response to queries to US, Europe, China, Japan, Korea and Rest of World market. 2. To co-ordinate with various department for the timely submission of documents and its compliance. 3. Coordination with quality control, analytical development lab (ADL) and corporate validation Lab (CVL) for specification and standard test procedures. 4. Coordination with CQA for document preparation and implementation. 5. Keep the track of technology/Analytical Method transfer and other documents received from ADL and R&D. 6. Responsible for co-ordination during regulatory inspections and customer audits. Responsible for co-ordination with all stake holders for appropriate action plans for the corrective and preventive actions (CAPA) and timely closure. 7. Review and approval of stability summary report and handling of stability failures. Responsible for timely communication with corporate regulatory department on the stability failures for further actions with regulatory agencies and customers. 8. Responsible for the co-ordination with QC and other agencies for the timely qualification of working reference standards (WRS) of APIs, intermediates and impurities. 9. Responsible for the management of Skip Testing and associated documents. 10. Responsible for ensuring compliance of products against monograph specification. 11. Review and approval of analytical raw data before the regulatory submissions for filing. [B] Validation. 1. Responsible for review and approved of Process Performance Qualification protocols and reports through Documentum system. 2. Responsible for review and approved Cleaning Validation and Verification protocol and report through Documentum system. 3. Ensure compliance of validation master plan. A. Batch release and Dispatch: 1. Responsible for batch release, Certificate of analysis and material dispatch related activities. 2. Responsible to communicate the business development and PPIC in case of any delays in the dispatches due to any reasons. B. QMS: 1. Responsible for Handling of Market complaint, returned goods and Recall activities. C. Product review: 1. To ensure preparation, review & approval of Annual Product Quality Review (APQR) as per scheduled timelines in coordination with other departments. D. Audit and Compliance: 1. Responsible for audit preparation, compliance and response to regulatory and customer. 2. Responsible for Retain sample management of APIs & Saleable Intermediates. 3. Perform internal audits within Alembic site. E. Customer Support/ Compliance: 1. Co-ordinate with Production, QC, supply chain, logistic, purchase and Marketing department for dispatch related activities and customer queries. 2. To support the business development team during the development of new customers by providing required information as part of questionnaire assessment and Technical quality agreement. 3. Coordination with quality control for specification, standard test procedures and QC related queries generated by customers. 4. Handling of CAPA & Change control activities for implementation, monitoring and assessment. 5. Review and approval of documents in DCS/Documentum. 6. Any other task assigned by QA Head.

Job Title: Executive - Senior Officer - Quality Assurance Department: Quality Assurance Location: Vadodara Experience: 4 6 years Qualification: B.Pharm / M.Pharm Job Summary: The Executive Quality Assurance is responsible for ensuring compliance with cGMP standards through effective execution of Validation, Annual Product Quality Review (APQR), and Quality Management System (QMS) activities. The role involves coordination with cross-functional departments, documentation management, and continuous quality improvement. Key Responsibilities: 1. Validation: Prepare, review, and execute validation protocols and reports (Process, Cleaning, Equipment, HVAC, Utilities, etc.). Ensure timely qualification and requalification activities. Review and evaluate validation data and ensure compliance with regulatory and internal quality standards. Coordinate with production, engineering, and QC for smooth execution of validation activities. Maintain validation master plan and validation documentation repository. 2. Annual Product Quality Review (APQR): Coordinate collection and review of data from production, QC, and other departments for APQR. Prepare and compile APQR reports as per regulatory guidelines and internal SOPs. Identify trends, deviations, and opportunities for process improvements based on APQR findings. Ensure timely completion and approval of APQRs. 3. Quality Management System (QMS): Participate in implementation and maintenance of QMS elements (Change Control, Deviations, CAPA, Risk Management, Document Control, etc.). Ensure timely closure of QMS records and proper documentation. Support internal and external audits, including regulatory inspections. Contribute to continual improvement initiatives and ensure regulatory compliance. Key Competencies: Sound understanding of cGMP, ICH, 21CFR, WHO, and regulatory requirements. Strong analytical, documentation, and communication skills. Proficient in handling QMS software (e.g., TrackWise, Veeva, or similar tools). Ability to work independently and as part of a team. Attention to detail and quality-focused mindset. Preferred Skills: Experience in pharmaceutical manufacturing environment (oral solid dosage). Exposure to regulatory audits (USFDA, MHRA, EU, etc.). Knowledge of data integrity practices and electronic documentation systems.

We are seeking a motivated and detail-oriented Graduate Functional Safety Engineer to join our dynamic and growing team. This is an excellent opportunity for a recent engineering graduate or an early-career professional with a passion for functional safety in complex embedded or automotive systems . You will be trained and mentored by experienced professionals and contribute to delivering cutting-edge safety solutions for leading OEMs and Tier 1 suppliers , working in alignment with ISO 26262 . Key Responsibilities Support system-level functional safety tasks across the V-model lifecycle. Assist in Hazard Analysis & Risk Assessment (HARA) , Functional Safety Concept (FSC) , and Technical Safety Concept (TSC) . Contribute to safety requirements, FMEA , and creation of other safety work products. Assist in developing safety plans , verification and validation strategies . Collaborate with cross-functional teams systems, hardware, software, and project management. Maintain traceability of safety requirements using tools like DOORS , Polarion , etc. Required Qualifications & Skills Bachelors or Master’s in Electrical/Electronic Engineering , Automotive , Systems Engineering , or related field. 0–2 years of experience in functional safety or systems engineering in the automotive/embedded domain . Basic understanding of ISO 26262 and system-level safety lifecycle. Familiarity with V-model and system engineering principles. Strong analytical mindset, communication skills, and eagerness to learn. Desirable Skills (Good to Have) Exposure to safety analysis techniques: FMEA , FTA , or FMEDA . Experience with tools: Medini Analyze , DOORS , PTC Integrity , or Enterprise Architect . Basic knowledge of automotive networks (CAN, LIN, Ethernet) or embedded control systems . What We Offer Mentorship and hands-on training by functional safety experts. Opportunity to work on innovative automotive and EV programs . Structured career development, certification programs , and continuous learning. Friendly, diverse, and collaborative environment of a UK-based company .

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys delivery team your primary role would be to interface with the client for quality assurance issue resolution and ensuring high customer satisfaction You will understand requirements create and review designs validate the architecture and ensure high levels of service offerings to clients in the technology domain You will participate in project estimation provide inputs for solution delivery conduct technical risk planning perform code reviews and unit test plan reviews You will lead and guide your teams towards developing optimized high quality code deliverables continual knowledge management and adherence to the organizational guidelines and processes You would be a key contributor to building efficient programs systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: 5 years of experience as a software developer focused on Oracle EBS development and implementation Expert level understanding of Oracle EBS Technologies Forms Reports Workflow SQL Loader Oracle Applications APIs Database concepts and optimization techniques PL SQL Unix Shell Scripts Oracle Database Upgrade 9i to 12c preferably Data mapping conversions interfaces and validation Strong understanding of EBS R12 data models across at least 2 modules Finance HR Supply Chain etc SQL queries including complex queries and use of TOAD Strong understanding of Software Development Life Cycle SDLC and agile methodologies Software development best practices and coding standards Design principles and architecture concepts Performance engineering and quality assurance processes Version control systems e g Git Additional Responsibilities: Knowledge of more than one technology Basics of Architecture and Design fundamentals Knowledge of Testing tools Knowledge of agile methodologies Understanding of Project life cycle activities on development and maintenance projects Understanding of one or more Estimation methodologies Knowledge of Quality processes Basics of business domain to understand the business requirements Analytical abilities Strong Technical Skills Good communication skills Good understanding of the technology and domain Ability to demonstrate a sound understanding of software quality assurance principles SOLID design principles and modelling methods Awareness of latest technologies and trends Excellent problem solving analytical and debugging skills Preferred Skills: Technology->Oracle eBS Technical->Oracle Application Development

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys delivery team your primary role would be to ensure effective Design Development Validation and Support activities to assure that our clients are satisfied with the high levels of service in the technology domain You will gather the requirements and specifications to understand the client requirements in a detailed manner and translate the same into system requirements You will play a key role in the overall estimation of work requirements to provide the right information on project estimations to Technology Leads and Project Managers You would be a key contributor to building efficient programs systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: 3 years of experience in Oracle EBS development and implementation Strong expertise in Oracle EBS Technologies Forms Reports Workflow SQL Loader Oracle Applications APIs Database concepts PL SQL Unix Shell Scripts Oracle Database Upgrade 9i to 11g Data mapping conversions interfaces and validation Oracle R12 data models and SQL queries preferably using TOAD Good understanding of SDLC and agile methodologies Software development principles Performance engineering and quality processes Additional Responsibilities: Knowledge of design principles and fundamentals of architecture Understanding of performance engineering Knowledge of quality processes and estimation techniques Basic understanding of project domain Ability to translate functional nonfunctional requirements to systems requirements Ability to design and code complex programs Ability to write test cases and scenarios based on the specifications Good understanding of SDLC and agile methodologies Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Preferred Skills: Technology->Oracle eBS Technical->Oracle Application Development