2270 Capa Jobs - Page 10

Location - Jigani. compliance with AS9100 / ISO 9001 standards. conduct internal audits. Quality Management System documentation, certification audits, MRB (Material Review Board, activities. Required Candidate profile Location - Jigani. compliance with AS9100 / ISO 9001 standards. internal audits. Quality Management System documentation, certification audits, MRB (Material Review Board, activities.

QMS Associate/Engineer (0–3 yrs) – Bengaluru | Manage & implement QMS, ensure ISO/IEC 17025 compliance, audits, calibration & documentation. Degree in Engg/Science. Salary 20k–25k. Immediate joiners preferred. Required Candidate profile Engineering/Science graduates (Mechanical, Electrical, Electronics, Physics) with 0–3 yrs in QMS, calibration, or compliance. Freshers with strong aptitude for quality and ISO/IEC 17025

Job Title: Senior Engineer Quality (Mechanical) About the Role As a Senior Engineer Quality (Mechanical) , you will play a key role in ensuring the quality and reliability of components and assemblies used in our electric vehicles. You will oversee incoming material inspections, drive quality systems, and collaborate with production and suppliers to resolve issues and implement continuous improvements. This role requires strong technical expertise, problem-solving abilities, and leadership skills to guide teams on the shop floor. Key Responsibilities Lead incoming quality inspection of fabricated sub-assemblies, sheet metal, fasteners, plastic parts, and post-coating processes. Develop, impl...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

In-process Quality & Customer Handle.Responsible for solving process & product related problem,quality improvement activities.To make internal audit plan for process and product.Handling customer complaint, taking corrective & preventive actions Required Candidate profile Monitoring customer complaint actions & their effectiveness.Responsible to maintain zero customer complaints & implementation of QA plan & documentation used in process control.Valid QA Documentation

Be responsible to lead downstream manufacturing compliance. Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item. Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA. Responsible for the review and approval of Master manufacturing records for the commercial batches. Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records. To review an...

Responsibilities: * Review of BMR's and BPR's, Process validation, hold time studies and cleaning validation protocols and reports * Dispensing and process areas line clearance activities

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with signif...

Key Responsibilities: Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs). Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments. Compilation and preparation of Annual Product Quality Review (APQR) reports. Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.). IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately. Ensure timely product release as per defined process and quality requirements. Work on company-wide quality strategies aimed at reducing non-com...

Warranty Claim Analysis Review and validate incoming warranty claims from customers, dealers, or service centers. Analyse failure modes using returned parts, failure data, and service reports. Categorize claims by defect type, frequency, and cost to identify recurring issues. One-page report readiness for customer signoff: Identification of defect phenomena with corrective and sustenance action. Regular monitoring of the Warranty test jigs at customer end to ensure no impact in signoff Coordinate with Plant ME for regular maintenance / upgradation of the test jigs placed at customer end Root Cause Analysis & Problem Resolution Conduct structured root cause analysis (RCA) for high-cost or rec...

Quality Control & Assurance Implement and maintain 7 QC Tools and 8D methodology for problem solving. Handle quality issues occurring during the shift; prepare and submit CAPA and action plans. Conduct rejection analysis and implement corrective actions to minimize rework. Perform L-process, final, first-off, and layout inspections. Attend line quality issues and support immediate resolution. Training & Development Educate shop floor teams on QMS standards, quality tools, and best practices. Conduct skill enhancement training for new and existing operators. Documentation & Audits Prepare IATF 16949:2016 documentation and ensure compliance. Support PPAP, FMEA, SPC, Product, Process & System a...

Role & responsibilities Handling the entire plant quality assurance activities includes: Implementation and maintenance of QMS throughout the plant Customer handling for quality-related queries Regular customer visits Customer complaint handling Supplier audit Internal rejection reduction In-charge of COPQ Maintaining TS 16949 system Customer audit Certification audits NPD quality PPAP, FMEA, CP, PFMEA, Poka Yoke Setting up and training quality team Supervising and reviewing daily activities of QMS Preparation of annual budget for the department and ensuring compliance Managing the Quality Lab MSA, Gauge R&R Cost-saving Kaizens, etc. Desired Candidate Profile BE / B.Tech in Mechanical From a...

At ABB, we help industries outrun - leaner and cleaner. Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen. It won't always be easy, growing takes grit. But at ABB, you'll never run alone. Run what runs the world. This Position reports to: Quality Control Manager What We Believe In At ABB, we are dedicated to addressing global challenges. Our core values: care, courage, curiosity, and collaboration - combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to empower everyone to create sustainable solutions. That's our story. Make it your story. Your Role An...

Key Responsibilities: Overall looking for documentation work of Engineering Department and presenting as Engineering Q.A. Active Participation with Q.A in Audit Works. Active participation in QMS work i.e QAP and relevant documents for EU Audits. Scheduling, Planning, Executing Departmental working & documentation work for Engineering Drafting of QAP, SOP, Logbooks, Documents, etc and timely revision according to schedule. Drafting of Engineering SOPs for all machines/utilities accordance with manufacturer recommendations along with performing Qualification activities and accordingly designing logbooks and records. Drafting of In-house Qualification documents with respect to manufacturers do...

Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...

JOB DESCRIPTION Purpose: Define, establish, and monitor quality management systems at EM&S APAC as per cGMP and Sanofi Global Quality policies to ensure the quality of products DP and DS. To ensure regulatory compliance for domestic and export Drug products and API manufactured by External Manufacturing sites of Sanofi. Collaborate with Quality Operations Cluster Head Quality Operations for rolling-out best practices and governance for CMO Quality Management within the EM&S APAC Quality network, ensuring quality oversight. Lead and coordinate quality and compliance of transversal projects for the EM&S APAC. Ensuring the renewal, registration, and maintenance of product dossiers & regulatory ...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvemen...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 3- 8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Own production execution and shift supervision; ensure lin...

The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Own production execution and shift supervision; ensure line clea...

The ideal candidate brings 8 to 10 year and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: QMS (Change Control, Deviation...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

The ideal candidate brings 2 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...

Production Executive based in Latur. The ideal candidate brings 0-1years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Own production executio...