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14.0 - 20.0 years
10 - 15 Lacs
Hyderabad
Work from Office
The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products (IMPs) and Medical Devices. Support data integrity incidents, manage escalations, and contribute to global DI (Data Integrity) networks and initiatives. Key Responsibilities: Manages technical complaints investigations to determine root causes and implement corrective actions to prevent recurrence. Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events. Review and approve complaints as the site Investigation approver. Manage multiple investigations concurrently. Periodically analyze trends in technical complaints. Participate in audits and inspections, including inspection readiness activities. Handle data integrity escalations. Implement and drive global Data Integrity (DI) network initiatives Essential Requirements: More than Over 14 years of practical experience in the chemical/ pharmaceutical industry or over 5 years of experience in pharmaceutical operations . In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-. Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion. Experienced in cGMP manufacturing, Quality, and Compliance. Experience in handling the Peptides. Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking. Capable of completing routine tasks with minimal direction Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as we'll as medical devices, packaging and distribution related topics Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations. Excellent verbal and written communication skills. Project Management Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines
Posted 2 months ago
5.0 - 10.0 years
8 - 10 Lacs
Bengaluru
Work from Office
Mission IQL is part of the development team for OCP project. Management of industrial risks which could affect the Quality of the developed offer along its supply chain from first raw material to the storage in the last plant before shipping to logistic center. Robustness of the Quality files used by Offer Management team (CE, OQL, Technical Antenna, Plant Quality, Supplier Quality) Identification of the Mandatory Requirements for Key Process in CQCS-P & PQCS-P for keeping the robustness of the offer along its life cycle. Follow up of the criticalities of components and assemblies up to Transfer milestone Quality level of each component, Sub-Assembly, and manufacturing process at each Stage Gate Transfer quality data for parts and process to suppliers and plant Roles & Responsibilities Guarantee that the Voice of the Customer is well translated and ranked in term of criticality (parts, sub-assemblies, and process) Support and train project team on methods and tools needed to reach robustness, capability and Quality risks management Identify and report to project management any Quality risk Lead the Quality issues resolution in applying the appropriate methods and tools Transfer Quality files to plant resp. for parts and process. For Process and Assembly line: Lead Product/Process FMEA and follow up. Ensure the Quality items of the Process Qualification Plan and Report (incl. Control means, KPI). Create the Process Quality Control Plan (PQCP) to be delivered to plant for its Process Control Plan. Propose the Target RPN matrix for each process line. Lead the actions plan for reaching the Target RPN matrix. Identify Mandatory Requirements for each Process line and ensure their completion. For Parts industrialization: Create and up-date the Component Risk Dashboard. Lead the Risk Analysis for each component characteristic. Ensure completion of MCSV process and files. Define the Component/ Quality Control Plan including control tools needs. Evaluate supplier manufacturing process capability during Qualification phase. Communicate with suppliers on quality requirements. Provide proper training if necessary. Audit supplier process when needed. Ensure reliability of measurement. Ensure the PPEP (Parts & Product Evaluation Plan) leadership and its stage gate reviews. Validate the Incoming Control Plan of the plant. Identify Mandatory Requirements for each component (process and control) and ensure their completion. Skills Capabilities of tools and equipment NQC, MDR, DPMe at Pilot Run and Produce PFMEA completion at Pilot Run RPN (Risk Priority Number) for Process lines Qualification Mechanical or Electrical Engineering graduate with minimum 5 years of plant experiences in Quality position (Supplier and/or Process). Quality skills such those needed for Green Belt (Risks management, animation, statistic, FMEA, Metrology) Technologies (material, moulding, stamping, assembly, automation, ...)
Posted 2 months ago
1.0 - 4.0 years
3 - 6 Lacs
Gurugram
Work from Office
Evaluate potential product quality complaints and initiate applicable records and actions within proper Quality System. Own and process quality complaint as per applicable procedures. Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures. Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required. Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure. Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints. Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization. Performs other duties as needed and assigned.
Posted 2 months ago
5.0 - 6.0 years
7 - 8 Lacs
Vadodara
Work from Office
Maneja, Gujarat, India Job ID: R0089170 Date Posted: 2025-05-21 Company Name: HITACHI ENERGY INDIA LIMITED Profession (Job Category): Quality Management Job Schedule: Full time Job Description: Business Information Hitachi Energy is currently looking for a Manufacturing Quality Assurance Entry Professional for the High Voltage Business to join their team in Maneja Vadodara Gujarat, India. This team seeks a skilled and motivated individual. Hitachi Energy is a leader in high-voltage technology, offering a wide range of high-voltage products up to 1,200-kilovolt (kV) helping enhance the safety, reliability and efficiency of power networks while minimizing environmental impact. Our technology leadership continues to facilitate innovations in power transmission, enabling smart grids and enhancing eco-efficiency. Hitachi Energy s EconiQ high-voltage portfolio eliminates SF6 with reliable and scalable solutions for the lowest carbon footprint. The EconiQ line has achieved two world s first - the replacement of SF6 in existing high-voltage equipment called EconiQ retrofill and the breakthrough SF6-free 420 kV circuit-breaker. Hitachi Energy has placed sustainability at the heart of its Purpose and is advancing a sustainable energy future for all. The ideal candidate must enjoy working in a dynamic, fast-paced business environment. He or she must be flexible to accommodate business requirements and experience in working with diverse groups and cultures. The ability to multitask & delivers within timelines is essential. The candidate will have excellent communications skills. Mission Statement Manufacturing Quality Assurance work includes: Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product. Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products. Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards. Reporting and troubleshooting manufacturing process deviations and defects in finished goods An Entry Professional (P1) applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: Work is closely supervised. Problems faced are not typically difficult or complex. Explains facts, policies and practices related to job area. Your Responsibilities Conduct thorough material inspections in accordance with approved drawings, technical specifications, and review test certificates. Prepare and maintain comprehensive documentation related to quality, including inspection reports, calibration reports, NCR (Non-Conformance Reports), rejection data, QAP, and work instructions. Ensured quality clearance through SAP (QM Module), improving efficiency and consistency in product quality. Conduct root cause analysis of non-conformance using problem reports and tools such as 4Q, DMAIC, 7QC, and 8D. Preparing necessary IIPs (incoming inspection plan), checklist and CTQ (Critical to Quality) parameters to ensure best quality of material from supplier. Training quality third party employees in basic quality test routines to ensure quality process are followed as per standard. Regularly monitor production FPY data, identify repetitive failure modes and drive improvement actions. Review and monitor manufacturing non-conformance, deploy right problem-solving tool to drive improvement action. Ensure sustainable solution. Outgoing inspection. Perform routine Inspection of the raw material in IQC and participate in routine GEMBA for Daily Management Ensure product meets all required specifications before final packing in line with check points. Identify gaps and improve upon the same. Share findings within team/s to drive improvement. Ensure no product is delivered with open non- conformance REIWA:learnt data base and improvement project Built lessons learnt data base and share within team/s Ensure monthly Q-data are uploaded in RELEX tool. Internal and external audit. ISO : 9001 - 2015 Living Hitachi Energy s core values of safety and integrity, which means taking responsibility for your own actions while caring for your colleagues and the business. Your Background Qualification Diploma or B.E Electrical/Mechanical,. Experience of 5 to 6 years in Quality function preferably in Power sector industry. Must have & required skillset can be mentioned. Proficiency in both spoken & written English language is required Relocation. .
Posted 2 months ago
- 4 years
2 - 3 Lacs
Bangalore/Bengaluru
Work from Office
Quality Final Inspection Quality Management Systems Plastic Injection Mould / Sheet Metal Industry Job Location: Bangalore Peenya Industrial Area / Whitefield / Dabaspete /Mulbagal
Posted 2 months ago
5 - 10 years
10 - 15 Lacs
Hosur
Work from Office
Handle QMS, QC & Customer Assurance for Consumer Durable products People & Process Mgmt. Quality Management QMS EMS OHSAS Six Sigma Lean manufacturing Required Candidate profile B.Tech 5 - 10 Years experience in QMS, EMS, QC in Blue Chip manufacturing unit Experience in Six Sigma, TQM, OHSAS, Lean manufacturing Stakeholder management & good communication skills Perks and benefits Best As Per Industry Standards
Posted 2 months ago
3 - 6 years
6 - 10 Lacs
Savli
Work from Office
for performing various testing procedures in a laboratory environment for quality assurance Duties usually consist of making measurements, performing several routine quantitative and qualitative analytical tests, performing calculations and determinations on tests, and evaluating physical/chemical characteristics Familiar with the use of standard and industry specific specialized laboratory equipment Analyzes test results and experiments to ensure conformity to physical and/or chemical specifications Maintains records of analysis and tests applies broad theoretical job knowledge typically obtained through advanced education May require the following proficiency: Work is closely supervised Problems faced are not typically difficult or complex Explains facts, policies and practices related to job area
Posted 2 months ago
12 - 15 years
10 - 13 Lacs
Sonipat
Work from Office
Min 12 years of exp in Auto industry with atleast 3 to 4 years exp in bearings industry Familiar with TQM principles, iso 9001,iso 14001,TS process knowledge like Machining, CNC, VMC, Turning, grinding etc Able to handle OEM audits Required Candidate profile Candidate must be B.tech with atleast 12 years experience of handling Quality Assurance Handling customer audits, Working on rejection & rewor. Candidate must have excellent communication skills.
Posted 2 months ago
8 - 10 years
10 - 15 Lacs
Hosur
Work from Office
Handle QMS, QC & Customer Assurance for Consumer Durable products People & Process Mgmt. Quality Management QMS EMS OHSAS Six Sigma Lean manufacturing Required Candidate profile B.Tech 8 - 10 Years experience in QMS, EMS, QC in Blue Chip manufacturing unit Experience in Six Sigma, TQM, OHSAS, Lean manufacturing Stakeholder management & good communication skills Perks and benefits Best As Per Industry Standards
Posted 2 months ago
8 years
0 - 1 Lacs
Pune
Work from Office
Antolin is one of the largest players in the car interiors market internationally and number 1 worldwide supplier of headliner substrates. We offer products with high added value to outfit automobile interiors: Overhead Systems, Doors, Lighting and Cockpits & interior trim. We dominate the complete component cycle from component conception and design, through development and validation to parts industrialization and sequenced delivery. OUR MAIN ASSETS Talent 28,000 individuals drive us to success Financial strength Annual sales of 4.2 million euros in 2024 Profitable growth trajectory Global presence 26 countries 161 production plants and centers Just in Time 25 technical-commercial offices Role & responsibilities 1.Shift start Q-validation. 2.Production self-control, support and verification. 3.Flash audits. 4.Product audits. 5.Internal rejection management. 6.5S audits shop floor.
Posted 2 months ago
3 - 5 years
2 - 5 Lacs
Gurugram
Work from Office
Responsible for all the Q.A activities related to Quality, Hard goods and Soft Goods Taking care of shipment with the buying house. Q.A.s. Arranging pre - production meetings and discussing the extracts with production and finishing Q.A.s. Interacting with buying house Auditors and satisfying their queries. Getting final inspection done by buying house Auditor. Dealing with technical problems arising from time to time. Should be ready to Travel According to the Factory. Knowledge of Hard Goods & Soft goods, writing and Paper Stationery etc. Relevant Experience in Qa/ Qc (quality Assurance/ Quality Control in Buying House/export House/ Third Party Lab). Maintain the Quality Compliance of the Customers. To Ensure Product Delivery On Time to Meet Customer Satisfaction. Should be able to Handle Day to Day Activities with factories. To carry out all Kind of Controls/inspections like PPM, Inline, Midline, Final Audits etc. as per AQL System & as Defined by the Buyer in order to get the Product in Right Desired Quality Within the Given Delivery Date. Positive attitude about learning and working Excellent Communication Skill Ability to work independently Must be Positive, proactive & responsible BA Fluency in English Qualification - BA, Any PG Course equivalent to Post Graduate
Posted 2 months ago
2 - 6 years
3 - 5 Lacs
Ponneri, Chennai, Thiruvallur
Work from Office
Quality Management (QC/QA) Experience in the welding materials industry Major Tasks - Inspection of raw material and product quality - Process Quality Monitoring and rejection countermeasures - Establishment of quality standards and improvement activities - Customer response and quality document management - Various Certification/Standard Management (BIS, ISO, etc) Required qualification - At least 2 years of experience in quality control - Ability to use inspection equipment - Understanding the certification/Quality Standards (BIS, ISO, etc.) - English/Tamil communication skills Preferred Qualification - Experience in certification/standards (BIS, ISO) - Experience in the welding materials industry - Quality Data Analysis Capabilities (Excel, Minitab, etc.) Interested Please Call Mithra HR 9176616016
Posted 2 months ago
3 - 5 years
2 - 3 Lacs
Kala Amb
Work from Office
Roles and Responsibilities Conduct quality audits, inspections, and reviews to ensure compliance with industry standards and company policies. Identify areas for improvement and implement corrective actions to maintain high-quality products. Collaborate with cross-functional teams to develop and implement quality control processes. Ensure timely completion of all tasks assigned by management. Develop and maintain documentation related to quality procedures, protocols, and records.
Posted 2 months ago
2 - 5 years
2 - 3 Lacs
Mumbai Suburban, Mumbai (All Areas)
Work from Office
Conduct In-Process Inspections to ensure quality standards during production. Incoming Material Inspections to verify materials & components meet specifications. Final Product Inspections before dispatch. Required Candidate profile Candidate from Automobile or Manufacturing Industry preferred. Hands-on experience with measuring instruments like Vernier Caliper, & Micrometer. Strong attention to detail and problem-solving skills.
Posted 2 months ago
0 - 4 years
2 - 3 Lacs
Bengaluru
Work from Office
Quality Final Inspection Quality Management Systems Plastic Injection Mould / Sheet Metal Industry Job Location: Bangalore Peenya Industrial Area / Whitefield / Dabaspete /Mulbagal
Posted 3 months ago
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