2270 Capa Jobs - Page 13

To raise and get approval of UPD / PD / Change control and get approval from authorities. Handle LMS related activities and their timely completion. To do and arrange CFT meeting of related to QMS. To receive the market complaints and get closer timely after discussion with CFT team. To review and arrangement of all GMP format requirement like formats / log etc. Prepare yearly calibration schedule and their completion timely. To implement and monitor the CAPA. To complete the schedule training / on job training . To maintain / follow the cGMP / GQS guideline requirements.. To handle change control, deviation and other GMP compliance related documents and ensure that all compliance related do...

•Process, incoming, final quality •Handling Audits & visits clearance, Internal & external complains •Handling manpower •ISO 9001, FSSC 22000, FSMS •Measuring instruments & calibration •5S, Kaizen, RCA, CAPA, FMEA, COA, material test certificate

About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards. Key Responsibilities: Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications. Ensure all software, cloud platforms, and supporting infrastructure comply wi...

Role & responsibilities Knowledge and hand on experience on Quality system Able to handle Measuring instruments & its analysis ( MSA), Responsibility of maintaining & controlling the documents required for Quality system implementation Kaizen, Poka-yoke and improvement Ensure inspection activities at appropriate stages Maintain & control quality records Knowledge and handle the PPAP activities Preferred candidate profile Understand & handle the Customer requirements. Good communication skills From automotive industry

Hands-on experience in GMP-compliant manufacturing environment Exposure to regulatory audits (e.g. USFDA, MHRA, WHO). Deep understanding of GMP, ICH guidelines, and local / international regulatory requirements Skilled in preparing for and facing customer audits. Root cause analysis, CAPA implementation, and continuous improvement Familiarity with QMS software, oracle, SAP, Minitab, LIMS, and other electronic documentation systems. Involvement in quality systems: deviations, CAPA, change control, and batch release Experience in document control & validations Managing QA teams, mentoring staff, and cross-functional collaboration

Role & responsibilities Lead the plant quality function, including incoming quality, in-process quality, final inspection, and customer quality. Ensure compliance with IATF 16949, ISO 9001, and other customer-specific requirements. Manage customer audits, third-party audits, and internal quality system audits. Drive implementation of APQP, PPAP, FMEA, MSA, SPC and other core quality tools across the plant. Address and resolve customer complaints, including root cause analysis (RCA) and corrective/preventive actions (CAPA). Ensure proper documentation and control of quality processes and records. Monitor and improve key quality KPIs such as rejection rate, customer PPM, cost of poor quality (...

We are seeking a highly motivated and detail-oriented Quality Engineer to join our team. The successful candidate will be responsible for ensuring that products and processes meet established quality standards through testing, inspection, and process improvement. You will work cross-functionally with engineering, production, and supply chain teams to identify and resolve quality issues. Develop and implement quality control systems and inspection processes. Monitor and analyze quality performance metrics. Conduct root cause analysis and implement corrective/preventive actions (CAPA). Work with suppliers to resolve quality issues and ensure compliance with standards. Participate in internal a...

As a member of the Central Quality department, your role involves: - Conducting Vendor Audit & Compliances - Reviewing Procurement bill of material (PBOM) - Initiating and evaluating change control, Corrective and Preventive Actions (CAPA) through track wise software - Evaluating Certificate of Suitability (CEP) updation, Drug Master File (DMF) notification, and Vendor notification for implementation at formulation sites - Reviewing Quality Management System (QMS) documents of all sites - Auditing formulation sites as per self-inspection plan - Preparing Audit planner for Active Pharmaceuticals Ingredients, Excipients, packing materials, Key Starting Materials (KSM)/Intermediates, Sterile ar...

As a Quality Assurance Officer in the chemical industry, your role involves ensuring that products and processes meet established quality standards and regulatory requirements. You will be responsible for developing and implementing Quality Management Systems (QMS) such as ISO-9001, conducting audits, monitoring testing, analyzing data, and resolving quality issues. Your key responsibilities will include: - Maintaining documentation - Conducting Root Cause Analysis - Implementing Corrective and Preventive Actions (CAPA) - Performing Out of Specification (OOS) and Out of Trend (OOT) investigations - Collaborating with cross-functional teams - Operating and calibrating laboratory equipment - E...

Key Responsibilities: Conduct QC testing of raw materials, in-process & final products. Ensure compliance with HSE standards & ISO systems. Handle product color correction, lab equipment & documentation. Support audits, quality trials & SAP-related QA activities. Strong knowledge of IATF 16949, ISO 9001 standards. Hands-on with QC tools (fishbone, Pareto) & MS Office. Good analytical, communication & teamwork skills. Preferred: Experience in ISO/IEC 17025-certified lab

Greetings from Themesoft! We're looking for QMS Support Consultants to join our dynamic team in Chennai . This role focuses on providing L2/L3 functional and technical support for enterprise Quality Management Systems (QMS) , including TrackWise and Veeva Vault Quality , ensuring minimal disruption to critical Quality and Manufacturing operations. Location: Chennai, India Experience: 610 Years Shift Requirement: Must be flexible to work in shifts Notice Period: Immediate to 10 days joiners Expertise Skills: TrackWise , Veeva Vault Quality, Deviation , CAPA , Change Control , Audit Management . Key Responsibilities: Application Support: Handle L2/L3 support for QMS platforms (TrackWise, Veeva...

Role Summary: The incumbent will be responsible for managing end-to-end Quality Control activities at the factory, ensuring robust quality systems, zero-defect culture, and compliance with internal and regulatory standards. Key Responsibilities: Ensure standard QC procedures for RM/PM/Bulk/FG sampling and release are followed as per AQL, specs & analytical protocols. Audit and manage BPR, IPQC & QC documentation. Implement CAPA for non-conformance. Strengthen in-process checks and support plant teams in incident mapping & resolution. Drive improvement in QACI, QRI & QMS metrics; generate and publish QC MIS reports. Manage disposition of rejected/non-conforming materials and ensure traceabili...

Job Description Vault Quality DevOps - Perform technical analysis, regression & automation testing Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description R2 Testing Engineer Veeva Vault Quality The Opportunity MSD is an innovative, global healthcare leader committed to improving health and well-being in 140 countries around the world. Our product categories include heart and respiratory health, diabetes, infectious diseases an...

Job Description Quality Lead - Private Label FMCG (Non-Food: Home Care, Personal Care, Baby Care) Location: Bangalore Job Summary: The Quality Lead for Private Label FMCG (Non-Food) will be responsible for ensuring the highest quality standards in the development, production, and delivery of Home Care, Personal Care, and Baby Care products. The role involves collaborating with cross-functional teams, managing supplier quality, and adhering to regulatory compliance to ensure customer satisfaction and brand reputation. Key Responsibilities Define and implement quality standards, specifications, and guidelines for Home Care, Personal Care, and Baby Care product categories. Work closely with 3P ...

Job Description JOB DESCRIPTION This role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams Key Responsibilities Ensure adherence to cGMP and GDP practices during all in-process activities. Perform line clearance checks before starting production and packaging operations. Monitor and verify critical manufacturing and packaging parameters as per approved BMR/BPR. Review and ensure compliance with SOPs, protocols, and regulatory guidelines . Verify sampl...

Position Title Manager - Quality Position Summary The incumbent will be responsible for establishing, implementing, and maintaining robust quality systems to ensure the highest standards in project vertical. This role involves overseeing overall Quality Control, Material Inspection, Technical document approval including Supplier Contractor, Field Quality, Continuous improvement processes, ensuring compliance with 100% Frist time Right at each stage of work completion as per industry standards, regulatory requirements and Tender specification of Customer. Key Accountabilities / Responsibilities Quality Management System (QMS):- Develop, implement, and maintain the Quality Management System (Q...

Role & responsibilities * Prepare and Review SOPs and Guideline for DQA. * Formulate Documentation Process for the Key divisions of SRD and ARD. * Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists. * Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirements * Review process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies. * Handle Vendor Qualific...

Role & responsibilities Looking for a person in meticulous Quality Engineer with a strong background in the transformer manufacturing industry in the following responsibilities : Specializing in tank fabrication, copper conductor inspection, insulation quality checks, and component-level verification. Skilled in implementing robust quality control systems, conducting detailed inspections, and ensuring compliance with international standards such as ISO, IEC, and customer specifications. Known for driving continuous improvement, reducing defects, and ensuring high reliability of transformer units. Preferred candidate profile Conduct in-process and final inspections of transformer tanks, ensur...

1.Role & responsibilities Preparation and review of Standard Operating Procedures. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management. To impart internal trainings to DCAL Employees. Review of the Instrument qualifications and re-qualifications protocols of Quality control. Preparation & review of quality risk assessment documents. Review and approval of analytical data related to QA release. Review & Approval of Specification STP, Raw data sheet etc. To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline. Internal Audit and External audit Compliance To support RA for analytical assistanc...

Mission Key missions of the position: Ensure that Product / Process/Customer Quality targets are met Ensure Implementation of relevant quality requirements of WMS & IMS / IRIS Resolve Internal process and customer pain points systematically (Robust RCA and related actions) Responsibilities Main responsibilities: Ensure that Design Standards are respected, Critical characteristics identified & defined in PFMEA & control plans and respected. Ensure Preparation of Inspection & Testing Plan (Assembly & Testing Check sheets) for new product development Ensuring Internal FAI, track closure of open points, if any prior Customer FAI. Update the applicable Quality documentation (Assembly & Testing Ch...

Key missions of the position: Ensure that Product / Process/Customer Quality targets are met Ensure Implementation of relevant quality requirements of WMS & IMS / IRIS Resolve Internal process and customer pain points systematically (Robust RCA and related actions) Responsibilities Main responsibilities: Ensure that Design Standards are respected, Critical characteristics identified & defined in PFMEA & control plans and respected. Ensure Preparation of Inspection & Testing Plan (Assembly & Testing Check sheets) for new product development Ensuring Internal FAI, track closure of open points, if any prior Customer FAI. Update the applicable Quality documentation (Assembly & Testing Check shee...

Job Track Description: Performs business support or technical work, using data organizing and coordination skills. Performs tasks based on established procedures. In some areas, requires vocational training, certifications, licensures, or equivalent experience. General Profile Expands skills within an analytical or operational process. Maintains appropriate licenses, training, and certifications. Applies experience and skills to complete assigned work. Works within established procedures and practices. Establishes the appropriate approach for new assignments. Works with a limited degree of supervision. Functional Knowledge Has developed skillset in a range of processes, procedures, and syste...

Job Title- Quality Manager Location- Pune Experience- Minimum of 5 years of experience in Quality Responsibilities- 1. To co-ordinate and verify the implementation and maintenance of the Quality management System requirements as per ISO 9001 : 2015, ISO 14001:2015 and ISO 45001:2018 2. To review non-conformances reported in the audits and where required, decide corrective actions in consultation with the concerned departmental heads and verification for confirmation of implementation. 3. To review and reduce Inhouse rework , rejection and Scrap 4. Disposition of non-conforming products. 5. Prepare the PPAP document and upload on system 6.Calibration and certification of test and measuring eq...

Job Track Description: Performs business support or technical work, using data organizing and coordination skills. Performs tasks based on established procedures. In some areas, requires vocational training, certifications, licensures, or equivalent experience. General Profile Expands skills within an analytical or operational process. Maintains appropriate licenses, training, and certifications. Applies experience and skills to complete assigned work. Works within established procedures and practices. Establishes the appropriate approach for new assignments. Works with a limited degree of supervision. Functional Knowledge Has developed skillset in a range of processes, procedures, and syste...

Job Track Description: Performs business support or technical work, using data organizing and coordination skills. Performs tasks based on established procedures. In some areas, requires vocational training, certifications, licensures, or equivalent experience. General Profile Expands skills within an analytical or operational process. Maintains appropriate licenses, training, and certifications. Applies experience and skills to complete assigned work. Works within established procedures and practices. Establishes the appropriate approach for new assignments. Works with a limited degree of supervision. Functional Knowledge Has developed skillset in a range of processes, procedures, and syste...