833 Capa Jobs - Page 9

The Quality Engineer is a member of the Quality department. Primary Skill Functional expert for Change Management process. Knowledge of CAPA ,NC and Investigations along with change control process Resolve issues on SmartSolve for Change and Documentation Modules. Liaise with Master Data Team on resolving issues in SAP for the ECO notifications. Maintain procedures for Document Control and Change Control processes. Maintain Change Management process as per procedure. Review approvals and implement updates in a timely manner to support the various business units. Secondary Skill Strong computer literacy skills in Microsoft Office, drawing package (e.g. CAD) and an ERP (preferably SmartSolve and SAP) system. Highly organized with strong ability to prioritize tasks. Strong interpersonal skills.

Product Quality to be achieved at all stages namely • Incoming components Quality (Supplier’s components) • Process Quality • Final Product Quality Electro Hydraulic Actuators Pneumatic/ Hydraulic Actuators Must have Machine Shop Experience.

Role & responsibilities Responsible for LBU & Customer approval for CPK, GRR, Correlation, SPC reports Vendor Management & Spare parts Management Customer meeting & Micro Management Failure Analysis, 4M study, why why Analysis Team Management Preferred candidate profile Perks and benefits Cab Facility Food Insurance ESI & PF Benefits

Good knowledge about sampling plan and IQC control plan,Should know the Incoming quality control lab process in any EMS industry,Should know prepare the SOP & SIP and LRR,Daily basic process schedule & Tracking.Skill in yield and production process in EMS. Incomming Quality Control, Supplier Quality Engineering,,Online Relaiability Test,Process Quality Control, 1. Responsible for Leading the Quality function and day to day In-process Quality verification with consistent result both in terms of Quality and Quantity to meet daily plant output/customer requirements. 2. Performing in-process quality inspection for accuracy, specification parameters and workmanship. Develop and implement best quality processes in production 3. Tabulate and document data relating to products, processes, materials, its qualities, and reliabilities 4. Train staff, technicians, and professionals on the aspects of quality control activities. 5. Troubleshoot and resolve problems relating to quality using quality tools (DMAIC, 8D, 4Q, PDCA etc.) Capture and analysis of COPQ in order to achieve savings. 6. Conducting regular Inspections and Audits to assess product quality and compliance with established standards 7. Collaborating with production teams to Identify areas for improvement and develop solutions to address quality Issues.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

* Lead quality systems implementation, audits, and certifications (ISO, UL, VDE) * Manage internal, supplier & customer audits and resolve quality issues (8D, RCA, CAPA) * Oversee QA/QC operations including inspections, testing, and documentation Required Candidate profile Define & monitor Quality KPIs, drive continuous improvement initiatives Develop & lead the quality team to ensure operational excellence Collaborate with Production, R&D & Global Teams

Responsible for the Investigation of customer complaints received from telecollections via RTS. Job Responsibility Investigation of assigned customer complaints Root cause analysis of complaints and suggest corrective actions Primary contact for all customer experience reporting and complaint handling activities This individual is responsible for independently receiving, documenting, investigating, and coordinating responses on all complaints. Ensures timely investigation of and response to all complaints. This involves initiating and participating in investigations and corrective action arising from complaints. Maintains current and complete complaint files. Performs analyses of complaints and implant reports for trends and identification of potential corrective or preventive actions

-Conduct Sampling of Raw materials as per sampling protocol. -Maintain calibration records and instrument logbooks. -Perform testing/analysis of raw materials. -Doing QMS

HPDC and Machining stages. Knowledge of HPDC Process and Defect Identification. Handling Machining Process Quality activities. Proficient in Measurement Tools like Vernier, Bore Gauge CAPA (Corrective and Preventive Action) handling of 7 QC Tools Provident fund Health insurance Food allowance

Candidate should be able to achieve the organizational goal in maintaining the Quality Management system of API industry. He should be able to execute various function QMS like CAPA, Deviation, CC, Risk assessment ETC Candidate Profile: Should have minimum Two years experience. He should be able to work with the team and be willing to take initiative & challenge for completing the task timely

Job Description : 1. Review the product quality plan and customer standard requirement for new project promote to implement in process,Review customer requirement implementation. 2.Guide the process of customer complaint and customer response / product defect analysis, and review the customer complaint report. 3.Analysis of manufacturing process, inspection quality data and reports, summarize and refine and guide closed-loop processing. 4. Review relevant quality data reports based on customer requirements for product process quality data 5. Lead improvement verification of major abnormalities. 6. Guide internal and external audits and implementation of corrective and preventive measures 7.Guide 8D analysis preparation report as per customer complain analysis,review improvement measure in manufacturing process as per customer requirement. 8.Review , trial production preparation with concern project members ,prepare trial report as per PE analysis, review trial report with customer and send closer report. 9.Analyze and deal with abnormalities generated and feedback on the production line. 10.Coordinate with various departments and stations and follow up on the progress of abnormal improvement, online data DPPM factory report update as per customer requirements. 11.Track and confirm improvement verification and analyze the defects. 12.Summarize customer online test result data DPPM and review customer required control measure. 13.Review customer IQC LAR result and abnormalities counter measures 14.Summarize the customer major issues at the current stage, analyze the root cause,review monthly report with customer and formulate an improvement plan to solve the problem from the root cause. 15.Provide skills training for engineers and other personnel to improve the comprehensive strength of the undergraduate office. 16.Summarize the abnormalities of the previous quarter and formulate targeted process improvement plans during the quarter. 17.Recognize process difficulties in this stage and develop improvement plans 18,Summarize the abnormalities in the first half of the year and formulate targeted process improvement plans during the quarter. Review half yearly report with customer and review last six month challenge and solution measures. Other Requirement : 1.Handle customer internal and external audit results 2.Summarize the customer major issues at the current stage, analyze the root cause,review monthly report with customer and formulate an improvement plan to solve the problem from the root cause. 3.Provide skills training for engineers and other personnel to improve the comprehensive strength of the undergraduate office. 4.Complaint handling management with 2485 principal 5.Review daily work management of team and their output 6.Increase team capability for individual work 7.Monthly ,half yearly , yearly meeting with customer 8.Customer relationship management 9.Proactive approach to handle customer issues timely and healthy relationship to meet company bushiness goal . Key skills & Capabilities : 1,Decisiveness. The ability to make decisions, particularly when under pressure, is an important skill to master 2.Empowerment of others 3.Leadership ,good team management 4.Able to handle and communicate with customer VIP levels personals 5.Able to present quality approach ,reports to customer with great satisfaction 7.Easily can handle internal factory issues and promote to improvement. 8.Good communication and report preparation knowledge 9. 8D report strong understanding Desired Candidate Profile : 1. Good professional ethics and high moral standards. 2. Conscientious, detail-oriented. 3. Strong psychological ability, can perform well, and maintain clear logic under pressure. 4. Candidate who can speak or write English will be preferred. PPT, Excel Perks and Benefits As per Company's Norms Role: CS - Quality Manager / Assistant Manager Industry Type: Electronic Components / Semiconductors Department: Quality Employment Type: Full Time, Permanent UG: B.Tech/B.E. in Any Specialization

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

As a Senior Analyst at Accenture, you will be aligned with the Customer Support vertical to manage and resolve customer queries, address escalations and complaints, and provide optimal resolutions within defined SLAs. Your role will involve closing faults and complaints efficiently while maintaining a high level of customer satisfaction. We are seeking a proactive candidate with excellent communication skills and a solid understanding of Customer Support metrics. Ideally, you should possess market knowledge of the US Wireless and Telecom domain, along with domain expertise in International Voice processes. Analytical skills and attention to detail are essential for this role. You must be capable of assertive communication, influencing others, probing for responses, and empathizing with customers. Previous experience in achieving targets within budget constraints is advantageous. In addition to individual proficiency, you should exhibit team-building skills to coach, connect, and motivate team members. The ability to define problems clearly, consider all available facts and alternatives, and make decisive and objective decisions is crucial. Familiarity with quality tools like RCA, CAPA, pareto, box plots, etc., is desirable. Your responsibilities will include communicating with client customers via voice to resolve issues, accessing internal systems for order information, and initiating necessary actions for responding to customer service requests. You should adapt effectively to changing priorities, collaborate with individuals at various levels, and take ownership of goals to drive yourself and the team towards achieving desired outcomes. Furthermore, you will be expected to monitor team expectations, project SLAs, knowledge sharing, and retention within the team. Collaborating with supervisors and managers to provide insights, performance trends, and agree on next steps will be a part of your routine responsibilities. Handling customer escalations and providing resolutions that require higher authorization will also be a key aspect of your role. If you possess a graduation degree and have 5-8 years of relevant experience, along with proficiency in English, we encourage you to apply for this challenging and rewarding position at Accenture.,

You will be responsible for performing line clearance activities before commencing operations, ensuring a clean and sanitized visual inspection and Packing area, and following the preventive maintenance schedule of machines. Operating the machines efficiently and filling the log of general areas as per SOP and work execution will also be part of your responsibilities. It is essential to adhere to cGMP, GDP, and maintain discipline in the department while ensuring that all employees comply with the same standards. Your role will involve ensuring that all equipment and production lines are in validated and calibrated status, preparing daily production reports based on achieved targets, and creating production plans on a monthly and daily basis according to material availability. Handling tasks such as change control, deviations, CAPA, investigations, and document management including BMRs, BPRs, and master SOPs will be part of your duties. You will also be involved in the preparation, review, revision, control, and implementation of standard operating procedures within the sterile manufacturing department. Conducting line clearance activities before commencing various operations such as manufacturing, sterilization, and filling, as well as checking and maintaining records and logbooks related to manufacturing processes, garment washing, drying, and equipment sterilization are key aspects of your role. Additionally, you will be required to perform any activities as instructed by the HOD, provide training to subordinates, technicians, and operators, and stay updated on self-hygiene practices. Attending training sessions as per the schedule and ensuring compliance with the Training Need Identification (TNI) will also be part of your responsibilities. Qualifications required for this role include M.Sc., B.Pharm, or M.Pharm degree.,

External Quality Culture Ensure awareness for quality focus to increase customer satisfaction, particularly in the development process Plan, implement and live Quality culture within Product Line and organization level (Implement the defined processes, improve product quality, initiate process improvements, and drive continuous improvements (CI) in projects) Ensuring compliance (of products) with legal and normative requirements (including tailoring of processes as appropriate) Effectively review product risk management activities (including Risk Analysis, Risk Management Report) Collaborate with onsite teams to keep project teams aligned with headquarters’ expectations Drive best practices within the organization Quality Management Define quality strategy in Quality Management Plan Drive process compliance in the complete lifecycle process of the medical device - starting with product definition till End of Support Act as independent reviewer for design reviews acc to QSR 820.30 (e) with the responsibility of defining and documenting the overall result of the design review. Work with internal delivery team and other functions in order to meet the specified Quality Goals of the project Supporting and consulting of employees in implementing and realizing the processes as well as decision about tailoring of defined processes - both according to the needs of the business and in compliance with statutory requirements Identify opportunities to improve productivity and efficiency with lower costs, reduce non-conformance costs Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA Reporting and Coordination Prepare and provide input to the periodic reports as needed by headquarter team Audits and Assessments Conduct / Participate in Internal Audit and External Audits using MDSAP methodology. Coordinate and ensure timely closure of audit findings Qualification Requirements Bachelors or Masters in Engineering / MCA having an excellent academic track record. Proficient in managing Quality of complete Software Medical Device Development lifecycle in distributed international environment. Experienced in latest trends of Software Product Development (e.g. Trunk Based Development, Continuous Delivery (DevOps) etc) Advanced knowledge of quality tools for Metrics data analysis and decision making Advanced computer skills (MS Office tools like Word, Access, Excel, PowerPoint and Outlook) Highly energetic and ”Go-getter” Proven ability to independently plan and successfully execute multiple projects based on business priorities. Display of a high level of critical thinking in bringing successful resolution to high-impact, complex and cross-functional problems is expected. Advanced knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. Excellent organizational and communication skills (e.g. Moderation, presentation to all levels). Auditor experience in Medical Device area is preferred. 4 - 8 years of successful experience in Quality Management and demonstration of Key Responsibilities and Knowledge as mentioned above. Advanced degree MAY be substituted for experience, where applicable.

- Knowledge of maintaining agricultural produce - To maintain standards and specifications of all raw materials - Vegetables & Fruits and also finished products - To assist in all areas related to product quality including trouble shooting, visiting, production, facilities, designing, training, quality control panel - To provide information that is accurate, reliable and adequate for the intended purpose - Keep the management team apprised of the quality issues - Responsible for inspecting and documenting all incoming fruit, vegetables, packaging materials, and ensure all product quality standards are adhered to. - Perform routine quality and condition inspections on existing inventory to assist in first-in, first-out (FIFO) or worst-in, first-out (WIFO) stock rotation. - Ensure all inbound carrier trailers and materials meet company quality and food safety standards. - Communicate Quality Assurance issues, including defect levels and problem loads, to Sales, Production, and QA managers. - Verify customer specifications, quality requirements of product orders, documentation submitted and approved vendors. - Coordinate inspections - Maintain instruments, records of calibrations, and supplies as needed to meet quality inspection requirements to ensure that company standards are met. - Work closely with Production and Warehouse departments to ensure effective stock rotation to reduce shrinkage. - Maintain daily inbound inspection and defect reports, weekly inbound raw material reports and keeps accurate documentation for food safety purposes. - Responsible for daily sanitation of equipment, and inspect repack products as needed. - Ensure quality of product meets quality standards and communicate any inconsistency to sales, purchasing, management, and quality control department.

Job Description : 1. Review product quality plans, validate customer requirement in process ,close customer quality requirement timely. 2.Customer online defect analysis ,guide to CS technician how handle online abnormality ,failure analysis and verification on time. 3.Guide the process of customer complaint and customer response / product defect analysis, and prepare the customer complaint 8D report. 4.Guide CS technician about software installation in customer IQC/LAB ,assistance in RMA verification process. 5.Trial production report preparation ,review with customer ,collect all data report for new project as per customer requirment ,summarize it and send to customer with closer report. 6.Review relevant quality data reports based on customer requirements for product process quality data. 7.Review customer online and IQC test result DPPM data ,if exceed standard follow-up control measures in manufacturing process as per customer standard DPPM requirements. 8.Prepare daily/weekly/monthly report and review with customer, validate repair product process as per customer requirements. Other Requirement : 1.Risk assessment 2.Customer complaint handling 2485 rule. 3. Follow-up improvement measure according to customer requirements. 4.8D review 5. Trial production customer requirements and review report 6. Customer online abnormality handling on time. 7. Customer Audit handling and closer follow-up Key skills & Capabilities : 1.Handle customer internal and external audit results 2.Summarize the customer major issues at the current stage, analyze the root cause,review monthly report with customer and formulate an improvement plan to solve the problem from the root cause. 3.Provide skills training for engineers and other personnel to improve the comprehensive strength of the undergraduate office. 4.Complaint handling management with 2485 principal 5.Review daily work management of team and their output 6.Increase team capability for individual work 7.Monthly ,half yearly , yearly meeting with customer 8.Customer relationship management 9.Proactive approach to handle customer issues timely and healthy relationship to meet company bushiness goal . Perks and Benefits As per company norms.

Maintain QMS/ISO standards Lead in-process and final quality inspections Handle customer complaints, RCA & CAPA Manage audits and ensure process control Supervise quality team and lab testing activities Improve quality KPIs and reduce rejections Required Candidate profile Degree in Mechanical/Industrial Engineering Strong knowledge of casting processes & quality tools Experience with ISO 9001 / customer audits Perks and benefits Food Is Available No Transportation

Responsibilities: * Manage quality systems implementation & documentation * Ensure compliance with ISO standards through audits & documentation * Collaborate on Capa initiatives within QMS framework Annual bonus Provident fund Mobile bill reimbursements

Role Purpose The purpose of this role is to conduct audits to ensure quality compliance within the account. Do Conduct process quality audits as per plan Conduct various process audits (1 audit/ agent/ week) as per procedure and guidelines For agents identified in the bottom quartile of performance, conduct 3 audits/ agent/ week Prepare findings from the report and share it with the client and the account leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes. Mandatory Skills: L&P Policy Acquisition & Servicing. Experience: 1-3 Years.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization

Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPOs defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality teams intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption Mandatory Skills: Data Centric testing.: Experience: 5-8 Years.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.