791 Capa Jobs - Page 10

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to ensure quality, cost efficiency, and on-time delivery of products. You will develop and implement production schedules while ensuring compliance with Good Manufacturing Practices (GMP) and USFDA regulations. Your role will involve maintaining regulatory compliance with USFDA, WHO, and other standards, coordinating with the Quality Assurance (QA) team for audits, and ensuring proper documentation of manufacturing processes. Leading and mentoring the production team will be a key aspect of your job to drive optimal performance and regulatory awareness. You will be expected to foster a culture of continuous improvement, accountability, and teamwork. Identifying and implementing process optimizations to enhance productivity, efficiency, and quality will be essential. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain will be required to address production-related issues effectively. In terms of equipment and facility management, you will need to ensure proper maintenance and calibration of production equipment and facilities. Implementing safety protocols to uphold a hazard-free work environment is crucial. Resource planning will also be part of your responsibilities, involving managing raw material inventory and maintaining uninterrupted production. You will also be tasked with preparing and managing the production budget to optimize costs without compromising quality. For this role, a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field is required. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial capacity is necessary, along with a proven track record in USFDA-regulated environments and knowledge of cGMP, CAPA, and regulatory submissions. Your technical skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership and communication skills, as well as strong analytical and problem-solving abilities. The ability to work under pressure, meet tight deadlines, and collaborate effectively with various teams will be critical to your success in this role.,

Must have contributed to Customer Audit (Maruti VSA System) Inspect incoming materials, raw components, and in-process products Monitor manufacturing processes, Data inspections, testing,trends, patterns,potential quality PPAP Experience is must. Required Candidate profile knowledge of PPAP, MSA, SPC, CAPA, PFMEA mandate Investigate quality issues, identify root causes, and implement corrective and preventive actions to prevent future defect fasteners,screws,bolts know

1.As per QMS, implement, and maintain process controls and procedures 2.Identify, analyze, and resolve process-related quality issues through root cause analysis techniques (Fishbone, 5 Whys, FMEA 3.Work with cross-functional teams to identify CAPA Required Candidate profile 7. Conduct layout, process and product audits, report compilation and reporting. 8. Knowledge of GD&T. 3. Utilize (SPC, Control Charts) to track process stability and capability.

Initiation, review and approval of all types of quality management systems (Ex: Change controls, Deviations, Investigations, CAPA, OOS, and Complaints etc.) Handling of Return Goods. Handling of quality system and perform risk assessment to the required quality system. Conduct regular internal audits as per the need basis. Reviewing and approving of all documents (SOPs, Spec & STPs, Forms, protocols and reports etc.) Review of annual product quality review reports. Providing training on all cGMP topics to employees at site. Supporting to customer audits/ visits and regulatory audits. Support to provide necessary documents for amendments, annual updates and regulatory filings and CMC supporting documentation. Filling of questionnaires, declarations & quality agreements. Execution of additional responsibilities assigned by HO

• Follow up with supplier for Quality documents required as per IS standard. • Performed root cause analysis to identify and resolve defects with the help of ,Ishikawa, 7QC,8D, Why-Why analysis. • Conducting meeting with supplier for CAPA to reduce overall rejection. • Timely coordination with supplier ,Internally sharing rejection report, queries regarding test certificate . • Prepare Quality Assurance Plane (QAP) as per scope of work. • Inspection of Pre & Post fabrication activity. • Preparation of Welding procedure Specification (WPS,WPQR,WPQ) • Handling all measuring instrument as well as Tachometer, Sound level, Vibration measuring Instruments. • Conduct FAT with the customers to get the acceptance before delivery . • Vender inspection, Coordinating third party inspection agency, Prepared MOM with clients. • Incoming material Inspection ,Stage Inspection, Final Inspection prepared all documents as per ISO,API and ASME standard. • Coordinating and Guide at the time of final Inspection with Client . • Attend ISO9001:2008,ISO9001:2015Internal And External Audit

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR To carry out CIP & SIP of the vessels related to compounding and flitration area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder Preparation and periodic revision of SOPs related to compounding area. Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering, HR and administration for the day to day activities. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

knowledge of GMP guidelines, CAPA, deviations, change control. Handling SOPs, batch records, validation protocols, audits, regulatory inspections, aseptic practices. Equipment, process, cleaning, and method validation expertise.

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

To maintain and control overall QMS documentation. To monitor the compliance of standard operating procedure of all departments. Responsible to handling of FDA and certification works in absence of

Role & responsibilities Experience of handling licensing authority. Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc). Managing Document Control system-Tracking Document changes, Create Quality. Manual, SOPs (Standard operating Procedure),maintain computerized and written records/reports. Responsible in implementing companys quality system in compliance with regulatory body. Ensure requirements of licensing authorities and accreditation bodies. GAP analysis , Risk assessment. Working as a management representative. Assure work process improvement and problem solving. Conduct Quality Training. Conduct/perform Internal Quality Assessment. Coordinate workplace safety process improvements and safety audits. Conduct Internal Audit ,prepare audit report ,initiate management review meeting. Initiate CAPA for the deviation. Preferred candidate profile Experience in ISO. 25 years in quality or regulatory affairs in a healthcare segment. Must have Technical & Regulatory Knowledge. Quality & Compliance along with Technical skills. Communication, Critical Thinking, Organizational, Attention to Detail.

Role & responsibilities Experience of handling licensing authority. Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc). Managing Document Control system-Tracking Document changes, Create Quality. Manual, SOPs (Standard operating Procedure),maintain computerized and written records/reports. Responsible in implementing companys quality system in compliance with regulatory body. Ensure requirements of licensing authorities and accreditation bodies. GAP analysis , Risk assessment. Working as a management representative. Assure work process improvement and problem solving. Conduct Quality Training. Conduct/perform Internal Quality Assessment. Coordinate workplace safety process improvements and safety audits. Conduct Internal Audit ,prepare audit report ,initiate management review meeting. Initiate CAPA for the deviation. Preferred candidate profile Experience in ISO. 25 years in quality or regulatory affairs in a healthcare segment. Must have Technical & Regulatory Knowledge. Quality & Compliance along with Technical skills. Communication, Critical Thinking, Organizational, Attention to Detail.

Greetings from Infosys BPM Ltd., We are hiring Assistant Quality Manager for a global Service Desk project at Electronic City, Bengaluru and Hinjewadi, Pune, please find the below job description for your reference and apply if interested. Job Role: Assistant Quality Manager Work Location: Electronic City, Bengaluru / Hinjewadi, Pune (work from office) Education Qualification: Full-time graduation / Post graduation Experience required: At least 6 years of experience in Quality and Process Improvement in Service Desk domain. Job requirements: 6+ years of relevant BPM Quality management experience in Customer Service and Service Desk Operations Proven Service desk (Voice/chat/email) experience in managing overall effectiveness of IT helpdesk through ticket audits and other Quality Interventions. Added advantage if certified on ITIL methodology Experience in leveraging various Industry leading ITSM platforms such as Service Now, CISM and proven expertise in replicating key best practices and reporting from these platforms Experience in leveraging industry leading Quality audit platforms such as Verint, NICE or similar tools to drive enhanced user experience and efficiency of the Quality Team Experience in managing transition accounts and driving early-stage interventions to ensure Right first-time implementation of quality processes Diagnosis and implementation of improvement opportunities to solve chronic business challenges focusing on process effectiveness and efficiency. Added advantage if certified as Six Sigma Green/Black Belt Ability to enhance key Customer and User Experience metrics such as NPS/CSAT by driving focused initiatives by partnering with delivery and client teams Ability to analyze complex data and share key process and business inferences/insights with the leadership team, including proactive operational risks and challenges. Experience in modernization and digitization initiatives to enhance adoption of digital tools in the Service Desk space Regards, Infosys BPM Talent Acquisition Team

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Job Objective:To lead and manage all quality functions across the plant with a focus on ensuring that products meet customer and industry standards, improve internal quality systems, and drive continuous improvement in all processes related to sheet metal manufacturing. Key Responsibilities:1. Leadership & Strategyo Develop and implement quality strategies aligned with customer requirement.o Lead a team of QC engineers and inspectors.o Act as the point of contact for all customer quality concerns and audits.2. Quality Systemso Maintain and continuously improve IATF systems.o Lead internal audits, external audits, and management reviews.3. Inspection & Testingo Oversee dimensional and visual inspection of incoming, in-process, and final parts.o Ensure calibration of instruments and effective inspection setup (CMM, gauges, etc.).o Establish control plans and quality checkpoints in manufacturing.4. Customer Qualityo Handle customer complaints , 5Why and corrective action plans.o Ensure timely closure of customer and internal non-conformances (NCRs).5. Documentation & Reportingo Maintain quality documentation per QMS requirements.o Track and report quality KPIs: PPM, rejection %, rework %, audit scores, etc. Qualifications & Skills: Education: B.E in Mechanical / Production Experience: 9-12 years in sheet metal industry, with 4-5 years in a leadership role. Technical Expertise: GD&T, Root Cause Analysis Software: Familiarity with CMM software, MS Office, 3d soft Soft Skills: Leadership, communication, problem-solving, team building Other Requirement : 1. Aggressive Attitude. 2. Willing to stay near the plant location.3. Medically fitness mandatory.4. Work Discipline (Safety, Quality).5. Communication on daily work management.Monthly CTC : 60000/-Food Facility : Not Available.Transport Facility : Not Available.Working Days : 6Working Hours : 8 Hrs (Excluding Breaks)Shift : General ShiftWeekly Off : SundayBenefits :* On Role Job* PF, ESIC benefits.* Will help in building a career in the Quality Department* Will get training on various Quality Tools.

* Implement IATF auditing QMS * CAPA processes Supplier monitoring & audit Incoming inspection & team QMS documentation (IATF) Monthly data reporting Customer complaint & CAPA Incoming Activity Awareness Supplier Audit Manpower handling Office cab/shuttle Food allowance Health insurance Provident fund Annual bonus

Roles and Responsibilities Ensure compliance with ISO standards through implementation, documentation, and auditing processes. Conduct internal process audits to identify areas for improvement and implement corrective actions (CAPAs). Manage vendor audits, MRM systems, PPAP documentation, IATF certification requirements. Develop and maintain quality management systems (QMS) policies, procedures, and guidelines. Collaborate with cross-functional teams to ensure effective communication and coordination.

Job Title: Quality Engineer / Quality Control Inspector Job Summary: We are hiring Quality Engineers / Inspectors to ensure that products and materials meet established quality standards through inspection, testing, and documentation. The role involves working with plastic and mechanical components, ensuring compliance with internal specifications and customer requirements. Key Responsibilities: Conduct visual, dimensional, and functional inspections of first samples, in-process components, and finished products. Use measuring instruments like calipers, micrometers, height gauges, and VMM machines. Inspect plastic products for defects and conformance to specifications. Prepare inspection reports, maintain logs, and document rework/reject data. Hold non-conforming products and report to the QC supervisor. Affix seals/tags to approved products and reroute defective ones for repair or recycling. Support testing and validation of new materials and processes. Assist in troubleshooting and implementing corrective actions. Maintain calibration and proper functioning of inspection equipment. Ensure compliance with QMS and ISO 9001 standards. Maintain a clean and organized inspection area. May assist in training new workers. Required Skills: Observational, Analytical, and Technical skills Ability to read and interpret technical drawings and specifications Experience with process optimization and quality control Knowledge of QMS and ISO 9001 standards Proficiency in MS Excel, Word, and PowerPoint Strong communication and teamwork abilities Attention to detail and problem-solving mindset Familiarity with 5S methodology

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Role & responsibilities Oversee end-to-end manufacturing of SMRs, DC chargers, and Controller units. Plan and execute daily production schedules while ensuring optimal utilization of manpower and resources. Ensure on-time product delivery with quality assurance in line with ISO 9001 standards. Manage component-level testing, DOA repairs, and failure analysis and documentation. Lead deployment of new product lines, including technology transfer and localization. Coordinate with cross-functional teams (design, procurement, quality) for smooth product integration and ramp-up. Execute Lean manufacturing and Six Sigma initiatives to reduce waste, rework, and downtime. Perform RCA, CAPA, and 8D analysis for customer complaints and internal issues. Implement Poka-Yoke and SPC-based process control for key operations. Lead a team of operators and technicians; conduct regular skill assessments. Deploy and maintain DOJO Room training modules for operator upskilling. Review SOPs and WI (Work Instructions) to standardize operations. Monitor inventory and material movement using Visual Management techniques, ensuring WIP and FG optimization. Participate in customer audits and presentations showcasing improvements and KPIs. Preferred candidate profile Strong knowledge of Electronics Assembly / PCBA Assembly / SMR, Charger & SMPS Testing and manufacturing processes Hands-on experience with Lean, IPC, 5S, and Six Sigma tools RCA, CAPA, and 8D methodology expertise Proficiency in SAP, Excel, and Visual Management Systems Strong leadership, training, and communication skills

We are seeking an experienced and detail-oriented Quality Manager to lead our quality assurance initiatives in rubber component manufacturing. This role not only involves supervising quality control systems but also serving as the Management Representative (MR) responsible for implementing and maintaining compliance with IATF 16949 , ISO 9001 , and other relevant quality standards. The ideal candidate will have a strong technical background in rubber components, leadership skills, and a proven track record in regulatory and customer audits. Key Responsibilities Quality Management System (QMS): Serve as the Management Representative (MR) for IATF 16949 and ISO 9001. Plan, implement, and monitor QMS compliance across the organization. Coordinate internal and external audits, including certification, surveillance, and customer audits. Ensure timely closure of non-conformities and implementation of corrective/preventive actions (CAPA). Liaise with certification bodies and manage audit schedules, documentation, and readiness. Product Quality Assurance: Develop and implement quality control procedures to ensure that all rubber components meet or exceed customer and industry standards for quality, safety, and performance . Conduct root cause analysis and resolve quality issues through structured problem-solving methods (e.g., 8D, 5-Why, Fishbone). Oversee incoming material inspection, in-process controls, and final product verification. Supplier Quality Management: Audit and evaluate suppliers to ensure adherence to company quality requirements. Collaborate with suppliers to resolve quality concerns and drive continuous improvement initiatives. Cross-functional Collaboration: Work closely with production, design, and R&D teams to integrate quality standards into product development and manufacturing processes. Provide training and mentorship to production staff on quality tools, procedures, and documentation requirements. Data Management & Improvement: Monitor and analyze quality KPIs such as rejection rates, customer complaints, and yield. Maintain accurate quality documentation, including inspection reports, SOPs, FMEAs, control plans, and PPAP submissions. Drive continuous improvement projects using tools like SPC, FMEA, DOE, and Six Sigma methodologies. Customer Focus: Establish strong relationships with customers to understand and meet their quality expectations. Manage customer complaints and lead resolution activities to ensure customer satisfaction. Requirements Educational Qualification: Bachelor's degree in Mechanical Engineering , Rubber Technology , or Chemical Engineering . Experience: Minimum 5 years of experience in quality assurance/control in rubber component manufacturing . Proven experience as a Management Representative (MR) for IATF 16949 and ISO 9001 audits. Skills & Competencies: Deep understanding of QMS standards , core tools (APQP, PPAP, MSA, SPC, FMEA), and statistical analysis. Strong leadership, analytical thinking, and problem-solving capabilities. Proficient in Microsoft Office , ERP/QMS systems, and quality-related software. Excellent communication and interpersonal skills for cross-functional and customer-facing interactions. Ability to manage multiple projects and priorities in a fast-paced environment

NEED TO HANDLE LINE INSPECTION AS WELL CMM ,DRAWING STUDY Perks and benefits EL,CL,BONUS,MEDICLAIM,GRAUDITY,

leadership quality,Review line inspectors ,and plan their work and monitor,documentation as per ISO ,XRAY INSPECTION ,inward to Final Inspection Handling. Perks and benefits EL,CL,BONUS,MEDICLAIM,GRAUDITY,

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. Deliver No.Performance ParameterMeasure1.AuditAdherence to the calendar; audit targets Compliance % as per audit reports zero misses2.Process ComplianceCase targets 2 hours/ week logged to be updated with the process Mandatory Skills: L&P Policy Acquisition & Servicing. Experience1-3 Years.