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4.0 - 6.0 years
6 - 8 Lacs
Vijayawada, Visakhapatnam, Guntur
Work from Office
Summary -Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems About the Role Key Responsibilities: Ensure timely collection of required documents and information for document based GMP compliance inspection of manufacturing sites registered in Japan. Efficient communication with relevant stakeholders and manufacturing sites in timely manner. Support the following regulatory compliance activity under GQP/QMS. Work together and communicate effectively with manufacturing sites and other line functions to keep the compliance of Japan approval files for the products undergoing the following type of inspections: Partial Change Application (PCA) inspections: for any changes post approval of drug New Drug Application (NDA) inspections: for new drug approvals Periodic inspections: conducted for manufacturing sites every five years Proper collection of required information and share with relevant stakeholders Proper and efficient handling of information Rapid and proper management of critical information Proper cooperation with Novartis Japan NCQ members Status monitoring and trend of document collection timelines Report to Quality Assurance Supervisor in Japan Review collected documents and contents checks Ensure that a timely, effective, continuous quality improvement in corroboration with relevant stakeholders. Support projects of new product launch and product transfer. Provide support for the preparation and follow-up of GMP inspections at the Country Japan Ensure that a local Quality System and Standard Operating Procedures are in place for all GxP related activities and that compliance with cGMP is maintained through training and internal audits. Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. Contributes to an improvement of current processes and/or to an implementation of modified processes. Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation -Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Essential Requirements: Quality standards are understood, designed into work activity, andachieved. In accordance with departmental objectives such as support ofprojects with agreed quality and delivery date, passing of internal and external inspections Local GxP Quality systems in place and maintained. GxP risks proactively identified and effectively mitigated. Number of severity of GxP/DI issues identified during internal/external audits and timeliness of collection of required information. Timely completion of assigned activities. No critical observations from internal audits or Health Authority Inspections Desirable Requirements: Work Experience: Functional Breadth. Skills: Compliance Requirements. Continuous Learning. Dealing With Ambiguity. Decision Making Skills. Gxp. Industry Standards. Project Management. Quality Management Systems (Qms). Quality Standards. Risk Management. Self Awareness. Technological Expertise. Languages : English. Why Novartis: You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: . Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
Posted 1 month ago
13.0 - 18.0 years
45 - 50 Lacs
Alwar, Vadodara
Work from Office
Join an industry leader and make a positive change in the sustainable use of the world s natural resources. Together, we will transform the business and drive the industry toward a greener future. At Metso, you will be supported by our inclusive culture and a network of colleagues from around the world. With us, you will embark on a personal growth journey and are encouraged to realize your potential. This is your invitation to rise above the possible. Job posting end date: Introduction We are seeking a Head of Quality Data Management and System to join our CNS Global Quality Development team. You will be responsible for the overall management, governance, and continuous improvement of quality process data, reporting mechanisms, and associated systems, fostering a data-driven culture across the business area. This includes leading the development and implementation of innovative Quality Systems and digital tools (Quality 4.0 initiatives). You will drive digital transformation within the quality function by leveraging advanced data analytics, AI/ML technologies, and system integration to optimize processes, ensure compliance, and elevate overall quality performance. Your role plays a crucial part in CNS Quality Team, positively impacting data-driven business decision-making. In this position, you will report to VP of Quality & Lean. This position is mainly located in Alwar / Vadodara and it involves up to 30% of international travels. Team you belong to You will be part of CNS Quality Development team which, in addition of Quality functions, plays a critical role in shaping and executing our global quality data strategy We work closely with IT, CNS Business Lines, Supply Chain, and other cross-functional teams to ensure system integration and alignment of quality data initiatives What you ll do Develop and implement a comprehensive strategy for quality data management, systems, and reporting, aligning with overall business and quality objectives. Lead the continuous improvement, configuration, validation, and global deployment of the SAP Quality Module, ensuring optimal utilization and integration. Oversee the governance of quality data, establishing standards, processes, and procedures for data quality, integrity, data management, and compliance. Drive the development, implementation, and integration of new quality systems applications and digital tools, incorporating modern technologies like AI/ML and automation to enhance quality processes. Champion and lead Quality 4.0 digital transformation initiatives within the Consumables Business Area, driving the identification and implementation of technology solutions that enhance efficiency, ensure compliance, and enable predictive quality insights Lead, mentor, and develop a high-performing team of data management and systems professionals, fostering a culture of innovation, collaboration, and continuous learning Stay current with industry trends and advancements in data management, data analytics, SAP QM, AI/ML, system integration, and digital technologies, proactively recommending and implementing best practices Who you are Solid leadership experience in Data Management, Quality Systems, and related processes, with strong exposure to data science methodologies, advanced analytics, and digital transformation within a large, complex, global manufacturing industry Knowledge of the SAP Quality Module, including configuration, implementation, validation, and integration (S/4HANA experience is preferred) Strong understanding and practical application of Data Management frameworks, along with hands-on experience in data analytics and visualization tools, with a particular focus on Business Intelligence platforms such as Power BI Knowledge of artificial intelligence, machine learning, big data, and proficiency in Python for data processing, modeling, and automation Bachelor s or Master s degree in Computer Science, Engineering, Data Science, Information Systems, Business Administration, or a related technical or scientific field Availability for international trips is around 30% of working time. Hiring Manager: Clayton Amaro How to join - Working at Metso - About Metso - Diversity and Inclusion - Meet our people Metso is an equal opportunity employer committed to fostering an inclusive and diverse workforce culture. All qualified applicants will receive consideration for employment without regard to race, religion, color, nationality, gender, gender identity, sexual orientation, age, status as a protected veteran or status as a qualified individual with a disability. Metso is a frontrunner in sustainable technologies, end-to-end solutions and services for the aggregates, minerals processing and metals refining industries globally. We improve our customers energy and water efficiency, increase their productivity, and reduce environmental risks with our product and service expertise. We are the partner for positive change. Metso is headquartered in Espoo, Finland. At the end of 2024 Metso had close to 17,000 employees in around 50 countries, and sales in 2024 were about EUR 4.9 billion. Metso is listed on the Nasdaq Helsinki. metso.com
Posted 1 month ago
4.0 - 8.0 years
13 - 14 Lacs
Hyderabad
Work from Office
Job description Planit are world leaders in application testing and quality engineering. We provide solutions that support organizations to deliver high quality systems, applications, and IT architecture. Planit is now a proud NRI company and part of a global movement to deliver a sustainable and secure future through better Information Technology exchanges. Our team offer expert consultancy, bespoke services, tailored training and unique solutions to complex projects. Specializing in digital quality, Planit have a geographic footprint across many continents, with 1700+ permanent employees and have been recognized in Gartners Magic Quadrant for Application Testing Services. . About the Role: As an Engineer, you will consult to our top tier client base, covering all areas of the testing lifecycle in multiple domains. Knowledge and expertise on all software delivery methodologies and test processes, you will use your testing capability to deliver large scale projects on schedule and to the highest quality. Responsibilities: As Senior Automation Test Engineer, you will consult to our top tier client base, covering all areas of the testing lifecycle in multiple industries. Using your expertise in all levels of test methodologies and processes, you will work in a team responsible for the analysis and planning of large-scale projects and providing estimates for test resources. Skills Experience: Required skills include Selenium with Java and Rest Assured API. Overall experience: 4 - 8 Years Require a proactive, committed quick-thinking automation engineer having hands-on experience in Selenium. Strong technical experience in the programming language Java or C# or JavaScript Experienced in developing automation frameworks such as BDD, Data-Driven, Hybrid frameworks Excellent analytical and debugging skills Experience of working in an Agile environment is a plus Strong written and verbal communication skills, good presentation skills are a must. Experience in CI/CD tools: Jenkins/Azure Devops is a plus. Culture and Benefits: For the right person we will provide: - A competitive remuneration package with career pathways within the team as we continue to expand globally An open, flexible hybrid working environment where you can immediately see the impact of your work and delivery towards the business success All of the tools, software and support you need (weve just undergone a migration of our ATS platform with bleeding edge tool /process to enable success) Benefits including health insurance, Free LinkedIn Learning licenses, Training platforms internet reimbursement among others If you believe that this role is for you APPLY TODAY!
Posted 1 month ago
1.0 - 2.0 years
3 - 4 Lacs
Gurugram
Work from Office
GW Sports App is looking for Quality Assurance Executive to join our dynamic team and embark on a rewarding career journey. The Quality Assurance Executive is responsible for ensuring the quality and reliability of products or services within an organization. They play a crucial role in maintaining and improving the company's quality management systems, implementing quality standards, and identifying areas for process improvement. The Quality Assurance Executive works closely with cross-functional teams to develop and execute quality assurance strategies and initiatives. Key Responsibilities: Quality Management Systems: Develop, implement, and maintain quality management systems and processes. Ensure compliance with applicable quality standards, regulations, and industry best practices. Identify and assess risks, and develop strategies to mitigate them. Conduct internal audits to evaluate the effectiveness of quality systems. Quality Control: Establish and enforce quality control measures, including inspections, tests, and sampling procedures. Monitor and analyze product or service quality data to identify trends, issues, and areas for improvement. Collaborate with production, operations, and other departments to address quality concerns and implement corrective actions. Perform root cause analysis and develop preventive measures to avoid quality problems. Process Improvement: Identify opportunities for process improvement and work with cross-functional teams to implement changes. Conduct process audits to identify gaps and inefficiencies, and recommend process enhancements. Develop and implement quality improvement initiatives to enhance overall organizational performance. Utilize statistical analysis tools and techniques to evaluate process performance and drive continuous improvement. Documentation and Reporting: Maintain accurate and up-to-date documentation of quality processes, procedures, and standards. Prepare quality reports, including metrics, trends, and analysis, to communicate performance to management. Ensure proper documentation of non-conformities, investigations, and corrective actions. Training and Compliance: Provide training and guidance to employees on quality-related topics, procedures, and standards. Stay updated with industry trends, regulatory changes, and advancements in quality assurance methodologies. Support external audits and inspections, and ensure compliance with relevant quality standards and certifications. Qualifications and Skills: Bachelor's degree in a relevant field (e.g., quality management, engineering, or related discipline). Proven experience in quality assurance, quality control, or a similar role. In-depth knowledge of quality management systems, standards, and methodologies (e.g., ISO 9001).
Posted 1 month ago
4.0 - 6.0 years
2 - 5 Lacs
Kota, Jaipur, Bikaner
Work from Office
Effectively coordinate & supervise the Horticulture activities to ensure green environment at Plant, colonies and Mines areas for better living of employees and nearby population. Green belt development statutory requirement for industries. KRA (Accountabilities) (Max 1325 Characters) Supporting Actions (Max 1325 Characters) KRA1 Horticulture Coordinate & supervise for Horticulture activities to ensure green environment at Plant & Colony Daily work plan and check the progress on daily basis in Plant & Colony. Allotment of jobs to gardeners day to day with close supervision on Horticulture activities as per budget. Arrangement for procurement of materials, preparation of areas, development of new sapling in our nursery for use of new plantations, propagation of existing rear varieties. Feedback from gardeners and take appropriate actions. Maintenance of existing gardens ,maintenance of Nursery, preparation of flower bouquets, preparation of pots, testing of soil &Water, Pest and disease control in plants, lawns etc Preparation of compost manure through Horticulture wastes. Support to residents for development of their gardens. Maintenance of Orchard & Orchard fruit sale thru tender, supervise lawn mowers and other tools and tackles KRA2 New garden development Supervise gardeners for new garden development ensure continuous development of new saplings in the colonies & factory areas. Planning & budgeting for new gardens development ,prepare drawing ,arrangement of resources ,raise new saplings in our nursery, Coordinate for sale of plants ,pots, bouquets etc to our employees. Organize new plantations program in nearby villages under CSR activities and development of green belt in our 4 Mines. KRA3 Development of Gardeners Impart training to gardeners. Motivation of gardener s time to time supervision of gardeners. KRA4 Quality Systems Implement ISO, EMS, WCM , SA8000 & OHSAS related activities in the department Identify and address the abnormalities, unsafe conditions & practices, 5S activities. Execute implementation plan for SA 8000/OHSAS 18001-24 Implementation & Improvement of WCM scores- Attain EMS Targets, Internal Customer rating improvement, - ISO system improvement,- Statutory compliances. MUDA eliminations, WCM presentation, WHY WHY analysis, Develop One point lesson. Develop visual control and Model area. KRA5 Safety Assurance, Monitor Safety measures & safety practices to ensure accident free working to improve Safety & productivity of the entire plant along with Horticulture department Analyze accidents and ensure corrective actions. Perform HIRA. Report maximum Near Miss. Do safety Observation Rounds. Develop procedures and organize implementation of jobs required for safety improvement/statutory requirements. Monitor implementation. Guide for corrective actions. Implement safety measures. Training on safety measures. Encouraging the horticulture & housekeeping staff to adhere to the established safety regulations in the use of equipment & supplies at all times; ensuring compliance of regulatory requirements of the department KRA6 Event Management In the plant and Colony Premise Take initiatives and make key decisions; manage all Company , Staff Club & Mahila Mandal, Worker s Club etc events from concept design, decoration, and beautification to execution within stipulated budgets in high pressure corporate environment KRA7 Cost & Quality Control To optimize cost and expenses on in-house development of plants, bouquets, garland etc Process improvement projects based on Kaizen and similar operational excellence initiatives with respect to cost, resource deployment, time over-runs and quality compliance Conceptualizing, developing and implementing innovative practices for organizational improvement KRA8 House Keeping & weeding 1.Maintaining clean environment, beautiful lawns, roads, gardens, walkways in Plants and colony. 2.Weeding and removal of wild growth from Plant and colony area thoroughly with minimum expenses and innovative techniques. Qualifications: Graduate Report to: Senior General Manager
Posted 1 month ago
10.0 - 20.0 years
9 - 18 Lacs
Faridabad, Delhi / NCR
Work from Office
QMS - Manager Should have knowledge of IATF MACE / VSA VDA should be from forging industry of automotive background know how of all forging defects should have background of customer interaction knowledge of heat treatment process
Posted 1 month ago
2.0 - 4.0 years
3 - 7 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
Product Compliance & Quality Specialist Cotecna is a leading provider of testing, inspection and certification services. Founded in Switzerland in 1974, Cotecna started off as a family business and has now grown to become a world-class international player with over 7000 employees in more than 140 offices across 50 countries. As a Product Compliance & Quality Specialist , you will be responsible for ensuring that our products meet regulatory standards, quality benchmarks, and customer expectations. You will work closely with product development teams, suppliers, and regulatory bodies to establish and maintain compliance across all products. Key Responsibilities 1. Regulatory Compliance: Ensure products meet local, national, and international regulatory requirements (e.g., safety, environmental, and industry-specific standards). Stay up-to-date with relevant regulations and industry standards affecting product compliance. 2. Quality Assurance: Develop, implement, and monitor quality assurance processes and procedures to ensure product integrity. Conduct regular Factory quality audits and inspections to assess compliance with quality standards. 3. Test Protocol creation: Must have knowledge of defining specifications basis Quality, Regulatory, Safety standards. Must have acumen for product development. 4. Documentation Management: Maintain accurate and up-to-date records of compliance documentation, including testing results, certifications, and regulatory submissions. Exposure to Artwork approvals, management will be helpful. Prepare compliance reports for management review. 5. Collaboration and Communication: Work closely with cross-functional teams (Sourcing, Marketing, Product managers, Sellers, vendors) to integrate compliance and quality considerations into product development and manufacturing processes. Provide training and support to staff on compliance and quality-related issues. 7. Risk Assessment and Mitigation: Identify potential risks associated with product compliance and quality and develop strategies to mitigate these risks. Investigate quality issues and non-conformances, implementing corrective actions as needed. 8. Continuous Improvement: Drive initiatives for continuous improvement in quality systems and compliance processes. Analyze quality data and feedback to identify trends and opportunities for enhancing product quality. Qualifications, Experience and Technical Skills Bachelor s degree in a relevant field (e.g., BSC, MSC, Quality Assurance, Regulatory Affairs)
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Ahmedabad
Work from Office
ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department : Late Phase Quality Assurance Designation: Officer/Sr Officer Role: Clinical Data Management Auditor Experience 4-8 years: Education: M.Pharm/B.Pharm Salary: around 8 L Job Description: To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Client s requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects. Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements. To perform retrospective audits of study related raw data like Informed Consent Forms, protocol, project management plan and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report, Medical Imaging documents. Review of SOPs pertaining to Clinical Data Management (CDM) and preparation and review of SOPs pertaining to Quality Assurance. Audit of the clinical database and clinical data management documents (before database lock). Calculation of % Error rate for the clinical database (before database lock) and issue the same to clinical data management. Prepare CDM audit status for incorporation in Audit Certificate/QA statement. Review of Data Management Plan (DMP), Statistical Analysis Plan (SAP-clinical data management aspects) and e-CRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutic Research Ltd Conduct System audit of Clinical Data Management and preparation of audit report. Review of TMF, SMF and Site selection visit report, IMP release checklist. COMPETENCIES Accountability Communication Work Ethic Presentation / Communication skills Organizational Culture fit
Posted 1 month ago
3.0 - 7.0 years
2 - 6 Lacs
Pune
Work from Office
Job Description: Educational and Experience Requirements: Education: Bachelor s degree in pharmacy (B Pharm) or Chemical Engineering. Graduated from a reputed university or college, such as NITs, RECs, or Tier-1 state colleges. Experience: 3 to 7 years of experience in manufacturing or production. Job Description Mixing and Filling Operations Expert in liquid-liquid and solid-liquid mixing and filling processes. Proficient in packaging operations with a focus on accuracy, hygiene, and efficiency. Regulatory Compliance Implement and oversee manufacturing practices in strict adherence to FDA , WHO , and cGMP guidelines. Ensure processes meet global quality and safety standards . Project Management Successfully managed projects aimed at cycle time reduction , productivity improvements , and line balancing . Demonstrated ability to drive cross-functional teams towards project milestones and KPIs. Safety & Risk Analysis Conduct Pre-Startup Safety Reviews (PSI) , HAZOP , and Process Hazard Analysis (PHA) for new product introductions. Lead all Process Hazard Management activities for existing products to ensure safe and reliable operations. Process Analysis & Optimization Perform process capability studies , What-if analyses , and variability studies to optimize performance. Define and refine key process parameters such as cycle time , lead time , takt time , and line balancing . Process & Equipment Qualification Lead and support process qualifications , change control , and IQ/OQ (Installation & Operational Qualification) . Accountable for equipment calibration and maintaining validation records. Operational Excellence Foster shop floor discipline , team engagement , and a culture of 5S , system adherence, and compliance. Drive continuous improvement through SPC (Statistical Process Control) and process mapping . Documentation & Training Manage production reporting and ensure all process documentation is up to date. Conduct training programs for team members on SOPs and best practices. Customer-Centric Quality Management Conduct root cause analyses for customer complaints and deviations. Implement Corrective and Preventive Actions (CAPA) to drive continuous quality improvements. Operational Management Monitor and maintain line flow , output , and process control for optimal production efficiency. Capacity Planning & Resource Management Develop and execute capacity plans , shift planning , material issuance , and manpower loading . Use SAP applications (preferred) for planning, tracking, and analysis. Improvement Initiatives Spearhead yield improvement , OEE (Overall Equipment Effectiveness) , and automation projects. Apply Industrial Engineering techniques like cycle time , method , and work studies to improve productivity, quality, and safety. Process Redesign & Layout Optimization Identify opportunities and implement process redesigns , layout modifications , and workflow enhancements to boost efficiency and reduce waste. 1. Certifications Six Sigma Green Belt certification is preferred (not mandatory). 2. Regulatory & Industry Compliance Proven experience working with FDA , WHO , and cGMP standards. Sound understanding of ICH and WHO guidelines related to pharmaceutical manufacturing and quality systems. 3. Technical Proficiency Hands-on experience in commissioning and qualification processes (IQ, OQ, PQ). Familiarity with validation protocols and regulatory documentation. 4. Industry Exposure Demonstrated exposure to the pharmaceutical and healthcare industries, preferably in manufacturing or process engineering roles. 5. Corporate Experience Experience working in multinational corporations (MNCs) is preferred. Ability to work within structured environments and adhere to global corporate policies. 6. Career Stability Shows a stable career progression with limited job-hopping. Preference for candidates with long-term tenures in previous roles, reflecting reliability and commitment.
Posted 1 month ago
14.0 - 18.0 years
11 - 17 Lacs
Vadodara
Work from Office
Position: Deputy Manager- Liquid-Dielectrics Employment Type: Fixed Term Employment on ERDA Rolls for initially 03 Years, it will be regularized based on the performance Location: Makarpura, Vadodara Qualification: Essential: M. Sc. (Organic or Inorganic Chemistry) (Full Time) Desirable: Ph.D. in Organic or Inorganic or Polymer chemistry Experience Description ( Minimum 14 years to Maximum 18 years) Work experience in a testing laboratory or quality control department of industries in field of transformer oil testing involving following mentioned work areas Key Responsibilities 1. To plan and monitor the day-to-day activities of oil section 2. To achieve the revenue targets of section 3. To prepare capital & recurring expenditure budget for the section and take suitable actions/measures accordingly . 4. Purchase activities of lab. Including RFQ preparation, indent processing, technical evaluation 5. To motivate and guide the personnel of the section to carry-out R&D related to transformer oil. 6. Planning and implementation of quality system in the lab for all requirements of ISO/IEC : 17025-2017 7. To achieve annual revenue and capital budget decided by Management. 8. Prepare and monitor capital & revenue expenditure. 9. Improvement of productivity Skills required to perform above job effectively Technical: 1. Knowledge of organic & inorganic chemistry 2. Knowledge of oil testing & experience of transformer oil testing in an accredited lab 3. Experience of working in NABL accredited lab; Knowledge of quality system requirement as per ISO-17025 Behavioural: 1. Ability to take initiative, prioritize work, organize resources to achieve results and meet the deadlines set. 2. To interact positively with superiors, subordinates & team. 3. Ability of lead the team. IT: 1. Basic knowledge of computers & MS office 2. Knowledge of ERP software
Posted 1 month ago
2.0 - 4.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Roles & Responsibilities : We are seeking a detail-oriented and technically sound Purchase Quality Associate with 2-4 years of experience in supplier quality assurance and procurement quality control . This role requires hands-on experience in interpreting engineering drawings and creating quality-related target reports using IQS software . The ideal candidate will work closely with suppliers, sourcing teams, and engineering to ensure incoming parts and materials meet quality and technical requirements. Key Responsibilities: Review and interpret engineering drawings, specifications, and technical standards to evaluate supplier conformance. Use IQS (Integrated Quality Systems) software to create, manage, and analyze target reports and other supplier quality data. Support part qualification processes Collaborate with procurement to align supplier capabilities with technical requirements. Perform document verification , such as material test reports, RoHS/REACH certifications, and inspection reports.
Posted 1 month ago
5.0 - 10.0 years
3 - 5 Lacs
Bawal, Faridabad, Manesar
Work from Office
We need a senior Quality Engineer for the Faridabad, Manesar, Bhawadi location who is knowledgeable about casting, machining, as well as the sheet metal and fabrication fields, including quality documentation.
Posted 1 month ago
15.0 - 20.0 years
37 - 45 Lacs
Mumbai
Work from Office
Provide strong leadership Lead CMO Quality operations for India CMO and US CMO. India CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for India, ROW, EM markets through various business model like LL, P2P, In-licensing. US CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for US market through various business model like LL. Essential Job Functions: 1. To ensure availability and periodic revision of quality agreements (QAg) between SUN Pharma CMO sites. 2. To ensure product quality complaints, quality alerts, FAR, recalls etc are being handled timely and inline with QAg. 3. To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities requirements are met and CMOs maintain and improve the adequate level of compliance, through CMO oversight. 4. Proactively assess quality issues and ensure compliance to QA/QC regulatory requirements in manufacturing operations at CMO sites. 5. Prevent Quality or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Ensure that Non-compliance are to be addressed via robust investigation corrective and preventive actions (CAPA). 6. Accountable for implementing and ensuring compliance to applicable Global SOPs, Policies, Standards and Quality systems at CMO oversight function. 7. Responsible for CMO Quality functions lean design and execution of continuous Quality Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance and drive efficiencies. 8. Facilitate new product launch and technology transfer activities (Sun site RD) and ensure timely execution of related activities. 9. Drive annual risk assessment of CMO sites (India and US market), review the outcome, identify high risk sites/products and ensure remediation plan is in place either by de-risking of manufacturing sites or product manufactured therein. 10. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals at CMO oversight function. 11. Responsible for ensuring smooth collaboration with Sun sites, commercial, RA, RD, MSTG, corporate quality audit CMO sites for activities related to product manufacturing, release and other quality technical issues to leverage synergies. 12. Monitor and utilize industry trends, internal learnings and new regulatory requirements to Identify and upgrade quality management system, facility and processes to ensure compliance at CMO sites as applicable. 13. Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. 14. Periodic visit of high risk CMO sites to ensure quality and compliance of the sites. 15. Will perform other work-related duties, as required. Requirements and Qualifications: Basic Qualification: M.Sc./ B. Pharm / M. Pharm or equivalent. Industrial Experience Knowledge: Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in OSD and / or sterile formulations manufacturing. Exposure to various formulations like sterile, ophthalmic, aerosols, Creams, Ointments, Oral Liquids, Nutraceutical, capsules (Hard and Soft Gelatin) and tablets will be preferred. Knowledge of GMP s in FDA, Domestic and international regulatory environments. In-depth knowledge of FDA guidance s such as ICH is must. Strong organizational, interpersonal and communication skills. Ability to work effectively in multicultural matrix organization.
Posted 1 month ago
15.0 - 20.0 years
37 - 45 Lacs
Vadodara
Work from Office
Holds overall QA QC GMP Responsibility for Site in the Emerging Markets. Provide strong leadership and oversight to ensure responsibilities regarding QA, QC and all other QMS activities. The candidate is accountable for assuring the supply of high quality, GMP compliant drug products to Sun Pharma customers and markets. Responsible for leading, directing, identifying and setting quality goals, objectives, and ensuring perfect execution in alignment with Global Quality Goals. Candidate will maintain substantial compliance at all sites, including harmonization and implementation of Quality Systems procedures in alignment with Global Policies Standards. Acts as a champion for building a Culture of Quality across the organization. Accountable to assure all sites are ready for all Regulatory and Customer inspections at all times. Responsibilities Assigned: Ensure all Finished products and APIs intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, Sun policies SOPs. Track, trend, maintain and report all Quality and business metrics to monitor and action all QA QC compliance activities. Prevent Quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Non-compliance issues are to be addressed through corrective and preventive actions (CAPA). Ensure rationalization and management of Quality processes, operations and systems. Perform gap analysis to plan actions for continuous improvements. Resource planning and monitoring for head count projections, revenue, budget, capital budget and manage organizational development. Responsible for global lean design and execution of continuous Quality Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance, drive efficiencies and reduce cost of poor quality. Coach and develop direct and indirect reports, as appropriate, through ongoing, examples-based performance feedback, annual performance reviews and the provision of training and development opportunities. Perform all work in support of our Corporate Values of Humility, Passion, Integrity, Innovation, Quality, Reliability, Consistency and Trust and in accordance with established regulatory and compliance and safety requirements. Lead Global Projects as part of collaboration with GQLT. Act as key resource and provide guidance with regards to global regulations to Sun Pharma sites and affiliates to ensure overall harmonized approach to quality and compliance. Be a solution-oriented leader and role model SUN behaviors. Maintain a network of subject matter experts in critical GMP Operations. Support the development of global strategy to respond to system level audit observations, inspection findings and implement corrective actions, globally. Responsible for tracking and trending of monthly global QA reports, Global KPIs, QPIs and global quality complaints and assures all compliance elements are in place. Create and maintain 24/7 Inspection readiness at sites. Requirements and Qualifications: masters Degree in Chemistry, Pharmacy or relevant life scientific field is required Ph.D. in a related discipline would be an asset Industrial Experience Knowledge: A minimum 25+ years of experience in a pharmaceutical quality management leadership role, inclusive of directing and controlling multi-site operations and activities across multiple geographic regions with good exposure of Quality and manufacturing operations is required. A strong knowledge of GMPs in both domestic and international regulatory environments is required. Excellent and detailed knowledge of Quality/Compliance processes and programs for development and commercial products including regulatory requirements on a global level; working knowledge of safety and environmental regulations and guidelines are also required. A proven ability to lead, manage and motivate people with a variety of skill sets is required. Strong organizational, interpersonal and communication skills are essential. Excellent negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders. Ability to work effectively in an international multicultural matrix organization is strongly preferred.
Posted 1 month ago
15.0 - 20.0 years
12 - 17 Lacs
Bengaluru
Work from Office
Being in a senior-most technical position, responsible for architecture, design, code, and delivery of multiple highly scalable systems Mentor/coach other engineers to help them perform at their best by performing code/design reviews, and providing all the technical directions Being hands-on and curious about the technology, get into the ground-level technical details/depth whenever required Work with other engineering teams cross-functional teams to address all the technical dependencies Actively participate in interviewing hiring the top talent Innovate and suggest industry best practices, and participate in internal/external technical presentations What we need: 15 or more years of industry experience working with product companies Strong CS fundamentals with an excellent track record of architecting, designing, developing, and delivering highly scalable systems Passionate about writing code and code/design reviews, who believe in building high-quality systems Experience in distributed systems at the cloud scale, microservices, large-scale web applications, and cloud technologies Startup experience and SaaS product development experience are added advantages Excellent communication skills with a can-do attitude/Self-starter
Posted 1 month ago
1.0 - 3.0 years
2 - 5 Lacs
Hyderabad
Work from Office
Brief team/department description: The Associate, Documentation Management plays a key role in maintaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position supports integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, ensuring adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11. Principle Responsibilities: Maintain and support a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal procedures. Support the validation, integrity, and ongoing compliance of electronic quality systems, including document management platforms. Support the Documentation Management System, ensuring all controlled documents (e.g., SOPs, policies, work instructions) are accurately authored, reviewed, approved, and updated per lifecycle requirements. Oversee document lifecycle activities, ensuring all documentation meets GxP and regulatory standards. Support the development, maintenance, and delivery of a GxP training program to ensure relevant personnel remain current with quality and compliance standards. Participate in continuous improvement initiatives aimed at enhancing the effectiveness of quality systems and documentation processes. Assist in the management and execution of the Computer System Validation (CSV) program, ensuring alignment with 21 CFR Part 11, EU Annex 11, and applicable internal validation policies. Support internal and external audits and regulatory inspections by ensuring documentation and systems are readily accessible and compliant. Qualifications and Education Requirements Bachelor s degree in Life Sciences, Pharmacy, Quality, or a related field. 1-3 years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry. Understanding of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulations. Familiarity with electronic Document Management Systems and Computer System Validation practices. Strong attention to detail and organizational skills By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 month ago
5.0 - 10.0 years
7 - 11 Lacs
Hyderabad
Work from Office
Brief team/department description: To support and maintain a robust, inspection-ready Quality System in alignment with global regulatory standards, ensuring operational excellence, data integrity, and continuous improvement in GxP environments. This role encompasses management of key quality processes including Change Control, Product Quality Reviews, and Risk Management. Principle Responsibilities: Maintain an efficient, compliant, and inspection-ready Quality System aligned with applicable GxP regulations and industry best practices Oversee the end-to-end change control process, ensuring timely assessment, approval, and implementation in compliance with applicable regulations. Coordinate and ensure timely completion of PQRs for all marketed products, including data collection, trending, evaluation, and final review. Support the implementation and monitoring of quality metrics and KPIs to assess system performance and identify areas for improvement. Provide governance for quality risk management processes and ensure timely escalation of significant issues to senior management. Manage Quality Risk Escalation and Quality Council meetings Identify and drive continuous improvement initiatives in quality systems and processes. Regularly report quality system metrics, status of change controls, and PQRs to the Head of Quality Compliance. Prepare dashboards and presentations as needed. Qualifications and Education Requirements Bachelor s or Master s degree in Life Sciences, Pharmacy, or a related discipline. Minimum 5 years of experience in pharmaceutical/biotech quality systems or quality assurance roles. Experience in PQR and change control management. Excellent communication, leadership, and problem-solving skills. Experience with quality audits and regulatory inspections is an advantage. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 month ago
5.0 - 10.0 years
5 - 9 Lacs
Mumbai
Work from Office
Product and Service Quality Gain deep understanding of data that impact service and product quality. Perform audits including subcontracted Services as well as Service Support visits for all new model 1st shipments, project installations or commissioning when requested.Work with Cross-Functional team in the resolution of key quality issues based on data. Work with Cross-Functional teams to address and solve key quality issues and inquiries, based on data and reported issues, including the ones affecting the Serviceability of Vertiv products, collaborating in the implementation of corrective actions with Service, Manufacturing, Engineering or any other function that can be involved. Work with business leads to drive corrective actions for Service and Manufacturing related issues. Help and drive Continuous Quality Improvement of processes within respective areas, proposing among others, the best practice sharing across region. Customer Quality Coordinate Customer audits, and address corrective actions. Assigned Customer Claims management coordination. Services Supplier Quality (In Cooperation with the Market Unit and Local Supply Chain) Support local Supply Chain by providing strategic quality support and expertise for the Services supplier quality. Cooperate with the local suppliers Manager in any claims processes within market unit, when requested. In cooperation Service Quality Organization, implement and maintain a common Service supplier quality documentation with local key suppliers. Reporting Provide monthly reporting for relevant Quality KPIs Others Follow all rules of H&S and living environment protection defined by internal procedures or communicated during trainings. Follows procedures, rules and principles of Quality Management System, Follow required actions to prevent all emergency situations and follows operation controls rules, Report all accidents, occupation diseases and emergency situations (where applicable) Develop and maintain effective communication within the business Perform other duties and oversees special projects and assignments as may be assigned by management Respect principles of local and international VERTIV Trade Compliance procedures connected with all operations and business practices. Education & Certifications: Please note minimum and preferred requirements for education. This includes degree, specializations and certifications. BE Electrical Requirements: Please list all experience required to perform this job. You may note some requirements as preferred. Preferred Engineering roles for at least 5 years in AC Power and UPS / DCPS knowledge. Fluent in English and desirable a second language. Strong leadership skills Strong verbal and written communication skills Well-developed interpersonal skills Active knowledge of quality systems, tools and standards desired Knowledge of Lean management Intermediate to Advanced in MS Excel. Smartsheet user Excellent problem solver; experience with 8D methodology and supporting tools Years of Experience: No Experience 1-3 years 3-5 years 5-7 years 7-10 years 10-15 years 15+ years Travel Requirements: No Travel 10% 25% 50% 75% Additional Benefits: MODUS Program/Company Car Special Physical Requirements: If there are additional requirements please check the box and then list the additional requirements. No Special Physical Requirements Heavy Lifting over 45 lbs. Constant/Frequent Standing Frequent kneeling/crawling/stooping Frequent climbing (stairs, ladders) Frequent driving (car, van, truck) Additional Requirements:
Posted 1 month ago
8.0 - 13.0 years
18 - 25 Lacs
Pune
Work from Office
Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standards through robust QMS implementation, audits & CAPA systems Required Candidate profile 8–12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge - ISO 9001, GMP & other quality standards
Posted 1 month ago
2.0 - 7.0 years
4 - 7 Lacs
Mumbai, Bhopal
Work from Office
DesignationSenior Quality Engineer Full Time Opportunity LocationFull Time Opportunity : - Maintain Plant-level Quality Culture and Quality System - Ensure compliance to ISO 9001 requirements - Conduct In-process and Final Inspections as per protocol - Ensure timely competence assessment of the Production team through Skill Mapping - Provide training & development to Production Team as per requirement to increase level of competence, productivity, quality - Drive continuous improvement of processes through systematic implementation of Kaizen - Identify NCs in Quality Management System and initiate corrective actions - Ensure compliance to National and International standards (BIS CRS, ENEC, CB, CE, RoHS) - Ensure product labelling match product specifications and applicable statutory and regulatory requirements - To monitor and direct day to day process development to ensure product quality, timely product shipments, continuing cost effectiveness and profitability - Improve operational quality results by studying, evaluating, and recommending process re-design; implementing changes; contributing information and opinion to unit design and modification of teams. - Maintain and improve product quality by timely investigation of customer complaints and completing product & quality system audits Required Skills: - Should have worked in Quality function in a similar capacity - Should have strong experience in problem solving tools - Should have knowledge in areas like Six Sigma, Lean and 5S - Should possess adequate Business Acumen - Should be a self-starter & a quick learner - Should be an excellent team worker - Should possess excellent communication skills This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.
Posted 1 month ago
4.0 - 9.0 years
3 - 6 Lacs
Ahmedabad
Work from Office
Knowledge of preparation of BMR, BPR, MFR, SMP, Change control, Deviation. Develop and implement quality assurance system Oversee quality control process Conduct internal audits & inspections Ensure laboratory compliance with regulatory requirements Required Candidate profile Bachelor's degree in a relevant scientific field like B.Pharma, M.Pharma, B.Sc Previous experience in quality assurance in laboratory setting or an API Mfg company Min 5 years of experience required
Posted 1 month ago
15.0 - 20.0 years
10 - 14 Lacs
Mumbai
Work from Office
Lead, support, and report independent GCP/PV audits according to the Novartis Quality Systems and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. Ensure alignment with the companys strategic direction and assist in driving the implementation of the applicable actions. Provide consultation to NVS business units through risk-based assessments. Act as SME for assigned areas of responsibility. Key Responsibilities: Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan. Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as we'll as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence. Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities. Prepare audit reports, according to NVS requirements and timelines. Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP) Identify and communicate quality and regulatory compliance issues to quality management through appropriate channels as we'll as recommend remediations. Lead compliance investigations and initiatives focused on inspection readiness and quality, process, and compliance improvement as requested. Support mock pre-approval inspections (PAIs) and HA inspections as needed. Proactively research local and global initiatives, trends, and events that impact the maintenance of compliance. Mentor GCP/PV staff as required. Complete any other request from global GCP Audit. Review and approve audit reports as required and also participate in the Lead Auditor program. Essential Requirements: 15+ years of proven experience in GCP / GPvP / clinical / industry / health authority experience or equivalent. 8+ years of GCP/PV auditing experience preferred and willingness to travel up to 60% of the time. Ability to lead and objectively evaluate compliance issues. Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision-making and problem-solving. Experience with Health Authority inspections and interactions preferred. Good quality and compliance leadership and facilitation skills. Excellent verbal and written communication, organizational, and interpersonal skills. Excellent computer skills including Excel, MS Office, etc Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. Good knowledge of CSV and 21 CFR Part 11, ability to lead audit teams, and operate successfully in various team capacities. Excellent leadership and facilitation skills, Auditor certification desirable. Desirable Requirements: Graduate in natural/biological sciences or equivalent, or an equivalent mix of education and experience
Posted 1 month ago
1.0 - 5.0 years
3 - 7 Lacs
Guwahati, Silchar, Dibrugarh
Work from Office
BACKGROUND . Over its 15 years of existence, THF has reached more than 35 million beneficiaries through its programs. THF works with communities through direct implementation of projects on the ground in addition to providing local management and monitoring support to not-for-profit organisations in India funded through THF USA and RIST. PROJECT OVERVIEW: PHC Assam (Amarpur, Assam) The Primary Health Centre Project in Assam, supported by The Hans Foundation, is an initiative aimed at strengthening primary healthcare delivery in rural and underserved regions of the state. Amarpur PHC in Tinsukia district is being adopted by THF in Assam. The centre will provide comprehensive primary healthcare services, including maternal and child health, non-communicable disease screening, mental health support, and health promotion. The PHC will be staffed by a Medical Officer, GNM, ANM, Lab Tech, Data Entry Operator, Pharmacist and other support staff, equipped with necessary medical equipment, diagnostic kits, and IT infrastructure for telemedicine and reporting. GENERAL Location of Job: Amarpur, Assam Annual Salary : Salary will commensurate with education, experience of the candidate and past salary drawn. No. of positions: 1 1. JOB PURPOSE The Medical Officer will be responsible for medical check-ups of the serving community through duties at PHCs following the visit roster, treating and providing consultation to the patients and maintaining. The Medical Officer will analyze medical check-up data and conduct regular inspection of equipments, maintaining the inventory of medicine required at PHC. S/he ensure compliance of the requirements and protocols as per Govt Rules. S/he will present the data to management and make suitable action plan. 2. KEY ACCOUNTABILITIES Conduct camp duties as per visit roster and perform medical check-ups of the serving community. Supervise and ensures the availability of inventory and supplies of drugs, reagents and equipment as required at PHC. Conduct home visits for elderly/ severely sick patients and persons with disabilities. Collaborate with other specialists and health facilities for timely, right referral of required cases. Analyse medical check-up data of the patients and provide counselling sessions as required. Management of the team and their capacity building. Ensuring optimum utilisation of available resources of the PHC. Maintain the confidentiality of the patient data and adhere the IPHS/IMC protocols for the treatment. Adhere and ensure implementation enforcement of Protocol/Quality systems. Ensure that documents like OPD, medicines and reagents consumption, patients cards etc. are updated and maintained regularly. Inspect the requisition and viability of medical equipment instrument at the PHC. Create awareness on health topics by participating in campaigns organized through PHC. Share the success stories/anecdotes from the field. Prepare trends of communicable and non-communicable diseases. Attend the periodic review meeting organized by THF team. Any other duties that may be assigned from time to time by the THF management. 3. Reporting to : Project Coordinator/ Project Manager 4. Other Indicative Requirements Educational Qualifications: MBBS Functional / Technical Skills and Relevant Experience Other requirements (Behavioural, Language, Certifications etc.) Minimum of 1-5 years of experience in public health programs with good team management skills. Candidate must have good communication skills in Hindi. Should be registered with National Medical Council.
Posted 1 month ago
8.0 - 13.0 years
16 - 18 Lacs
Pune
Work from Office
Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs. Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Perform independent technical assessment on product quality performance and post market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing. Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post market product quality analysis. Provide leadership and oversight to ensure Quality Management System Compliance. Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems. Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer. Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving). Youre the right fit if: (4 x bullets max) An Engineering degree in any discipline with at least 8+ years of relevant industry experience. Core expertise in Design Quality, Systems Engineering, or Reliability Engineering. Medical device industry experience is mandatory . Ability to define detailed systems quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate critical requirements. Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing. Ability to lead reliability analysis to assess the risks associated with design concepts. Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, , and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else. You are a self-starter who embraces the change How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role.
Posted 1 month ago
4.0 - 9.0 years
3 - 7 Lacs
Jamnagar
Work from Office
Quality Engineer (Industrial Flooring) - Avcon Technics Private Limited We are seeking an experienced Quality Engineer with 4 years of experience in the industrial flooring industry . The ideal candidate should have a strong understanding of concrete technology, flooring systems, and quality control processes to ensure high standards in our projects JOB DESCRIPTION Job Title : Quality Engineer (Industrial Flooring) Experience Required : 4 Years LOCATION : Jamnagar Key Responsibilities: Implement and monitor quality control procedures for industrial flooring projects. Signing quality report before concrete casting. Conduct quality audit weekly basis. Highlight the quality deviation. Understanding of concrete mix design & changes for suitability as per site condition. Modification in quality systems if required updation. Submit quality report to the management Highlight the quality discrepancies & challenges in maintaining the quality. Conduct inspections and tests on concrete materials, surface preparation, coatings, and flooring systems . Ensure compliance with industry standards, client specifications, and company quality policies . Investigate and resolve quality-related issues , including root cause analysis and corrective actions. Maintain quality documentation such as test reports, inspection records, and compliance certificates . Collaborate with project teams to optimize flooring application techniques and improve overall quality. Conduct training sessions for site teams on quality standards and best practices . Liaise with vendors, suppliers, and clients to ensure material quality and adherence to specifications. Stay updated on new technologies and advancements in industrial flooring and concrete. Key Skills & Qualifications: Bachelor s degree/Diploma in Civil Engineering, Materials Science, or related field . 4 years of experience in quality assurance/control in industrial flooring or related fields. Strong knowledge of concrete mix design, curing methods, and testing procedures . Familiarity with industrial flooring materials such as epoxy, polyurethane, and polished concrete . Hands-on experience with NDT (Non-Destructive Testing), surface profiling, and adhesion testing . Understanding of ISO, ASTM, BIS, and other relevant quality standards . Proficiency in quality management systems (QMS) and reporting tools. Excellent analytical, problem-solving, and communication skills. Preferred Qualifications: Certification in Quality Management (ISO 9001, Six Sigma, etc.) . Experience in working with large-scale flooring projects . If you are a dedicated Quality Engineer with expertise in concrete and industrial flooring , we encourage you to apply and be part of our team!
Posted 1 month ago
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