32 Qms System Jobs

IATF Requirements as per Company's Standard, BIS Audit, Customer complaints & Handling , Glass Process Inspection Analysis & Knowledge, Related Lab Responsibility & Testing For further information, please call 8050070079 / 8050011328

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Urgent job opening for Senior Quality Assurance Executive at Dombivli. Qualification : B.Sc., M.Sc. Experience : 6 to 8 years Description of Job Responsibilities 1) Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA. 2) Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc. 3) Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees. 4) To evaluate Quality and stability of finished APIs. 5) Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures. 6) To investigate & approve Deviations, Out of Specification 7) Responsible for preparation, review of MSDS and approval 8) Responsible for preparation, review & approval of annual product quality review. 9) Responsible for providing effective CAPA procedures, tracking completion and implementation of the same. 10) Responsible for validation activities as per validation master plan 11) Responsible to investigate & approve customer complaints and provide responses to customers regarding complaints. 12) Ensure handling, effectiveness and continuous improvement of the QMS System. 13) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 14) To organize & performed vendor audits for critical raw materials/ packing materials & testing labs. 15) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 16) Responsible for updating and maintaining Quality management system documents 17) To ensure that the preparation, submission of Drug Master Files to customers/ authorities 18) To ensure that responsible & provide the audit compliances, DMF query responses, market complaints/ queries related to documents or products 19) To organize and participate in MRMs and to monitor actions of the same 20) Responsible for procedures of approval/rejection/release/dispatch for commercial batches and documents. 21) Responsible for the preparation DMF (Close & Open part), replying to the QA / RA related queries of Marketing, Exports, Customers, Regulatory authorities & all work related to Regulatory Affairs (RA) functions. 22) Responsible for maintaining and handling of vendor qualification activities. If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details: 1) Current salary 2) Expected salary 3) Notice period 4) Total experience 5) Relevant experience 6) Current location 7) Reason for job change Contact no.:- Sakshi - 8591939527 Mail ID:- sakshi@jobsearchindia.in

Dear Candidate , we are hiring for Down Stream Process Executives & Operators Position . Experiance in handling the following Equipment Qualification: Bsc/Msc/ITI/B Pharmacy • M Pharmacy/Diploma/Btech/Any Degree 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation, CIP_SIP 6 Expertise in documentation QMS/GMP Compliance/Process Awareness Interested candidates please share your CV through Whats app (9381915043) Male Candidates & Biologics Company's only Preferable. "IMMEDIATE JOINERS ARE PREFERABLE"

Job Title : Manager Quality Assurance Department : Quality Assurance Reporting to : Assistant General Manager Quality Assurance Location : Akhand Jyoti Eye Hospital (Centre of Excellence) with regular visits to all satellite centres Purpose of the Role : To champion, sustain and continuously improve the Quality Management System (QMS) across the hospital network, assuring patient safety, regulatory compliance, and an all pervasive culture of excellence. Consolidated Job Description Sr. No.Broad Responsibility AreaKey Job Descriptions (JD)1Quality Management System (QMS) & Documentation Control Own the QMS and ensure alignment with NABH / ISO standards Maintain the master list of documents, SOPs, records and forms; review/approve revisions; control circulation of copies Drive periodic management review of QMS effectiveness 2. Regulatory & Statutory Compliance Monitor statutory licenses (BMW, PCB, etc.) and ensure renewals Track compliance with national/state healthcare regulations and patient-safety standards. 3. Internal Audits & Gap Assessments Prepare the annual internal-audit calendar; train auditors; approve check-lists Lead audits at base hospital and conduct gap assessments at satellite centres; ensure timely closure of NCs/CAPAs. 4. Committee & Governance Meetings ¢ Ensure Quality Steering, Infection-Control, Medication-Safety, OT-Users and other statutory committees meet at defined frequency; record & disseminate minutes; track action items. 5. Training & Competence Development ¢ Conduct induction and recurrent training on Quality Policy, Mission-Vision-Values, SOPs, patient safety, BMW, incident reporting, RCA & CAPA ¢ Coordinate calendared technical sessions with Training & Education department. 6. Patient Safety, Risk & Incident Management ¢ Lead weekly safety rounds (OT, OPD, wards, outreach camps) ¢ Maintain & update enterprise risk matrix; facilitate RCA & CAPA for all incidents/near-misses ¢ Submit quarterly risk-management report to leadership. 7. Clinical Protocol & Sterilization Oversight ¢ Verify OT sterilization logs, biological indicators, and adherence to infection-control SOPs Audit OPD, diagnostic areas and outreach camps for compliance with clinical pathways. 8. Data Analysis, Reporting & MIS ¢ Collate quality indicators, patient-flow time-motion data, incident stats and patient-feedback trends. Generate and present the monthly MIS deck to Senior Management & SIT; publish dashboards on intranet. 9. Patient Experience & Feedback Management ¢ Supervise systematic collection and statistical analysis of patient-satisfaction surveys & suggestion registers; develop improvement plans with process owners. 10.Continuous Improvement & Innovation ¢ Champion Lean/Six-Sigma or Kaizen projects to reduce waste and enhance clinical and administrative efficiency. Publish case studies and share best practices across centres. 11. Leadership & Team Management ¢ Direct and coach Trainee, Executive and Senior Executive QA staff; conduct weekly departmental huddles; perform goal-setting and appraisals Foster a culture of collaboration, learning and recognition within the QA team. 12. Stakeholder Communication & Quality Culture Promotion ¢ Act as quality ambassador; engage clinicians, nursing, admin, supply-chain and outreach teams to embed quality in every interaction. Publish quality alerts, newsletters, case studies on intranet and notice boards . Authority & Interfaces Internal : Asst General Manager QA, Department Heads, Training & Education, Nursing, OT, Outreach & Satellite Centres, Biomedical Engineering, SCM. External : Accreditation bodies (NABH/ISO), regulatory agencies, vendor auditors, donor-quality monitors. Desired Qualifications & Experience Bachelors / Masters degree in Hospital/Healthcare Administration or equivalent. 3+ years in hospital QA/QI; prior exposure to eye-care settings preferred. Key Competencies Deep knowledge of clinical governance, infection prevention, and ophthalmic clinical pathways. Data-analytic acumen; proficiency in Excel, QI dashboards & statistical tools. Influencing, coaching and change-management skills.

QMS - Manager Should have knowledge of IATF MACE / VSA VDA should be from forging industry of automotive background know how of all forging defects should have background of customer interaction knowledge of heat treatment process

We are looking for Quality Head, who has worked at least 10years in SGI Casting speciality in Manhole cover division. Maintain QMS, with computer knowledge. Job location-Howrah(WB),Salary-35k-45k Monthly. Walk in Interview. Contact : +91 7687919790

Planing, execute & close quality system audits.Monitored effectiveness of previous audits & submit them 2 customer as per requirements.Control quality system documents like PFMEA,PQCT,Work Instructions(WI),Appearance Standards, Inspection Standards Required Candidate profile Organize meetings on company rules & regulations & amend/modify as needed.Lead training sessions on company's guidelines.Maintained change & revision history of documented quality system information

Customer complaints management , Customer satisfaction Reduce the cost of poor quality Support to new development project Implement cost saving projects Implement cost saving projects Implement QMS Training and awareness Required Candidate profile knowledge of process improvement tools / techniques such as 6 sigma, VDA / Lean manufacturing team leading experience with Audit and Supplier quality

Develop and implement quality control processes and inspection plans for sheet metal fabrication. Perform in-process and final inspections of fabricated components to ensure conformance to specifications. Collaborate with design and production teams to resolve quality issues and implement corrective actions. Conduct root cause analysis (RCA) and lead corrective and preventive actions (CAPA) for non-conformances. Interpret engineering drawings, GD&T, and technical specifications. Ensure compliance with ISO 9001 and/or other applicable quality standards. Conduct supplier audits and assessments, and evaluate incoming materials and components. Develop and maintain quality documentation, including inspection reports, control plans, and quality records. Drive continuous improvement initiatives using tools such as 5 Why, Fishbone, FMEA, and SPC. Call or Whatsapp: 8983069228

Dear Candidate , we are hiring for Down Stream Process Executives & Operators Position . Experiance in handling the following Equipment Qualification: Bsc/Msc/ITI/B Pharmacy • M Pharmacy/Diploma/Btech/Any Degree 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation, CIP_SIP 6 Expertise in documentation QMS/GMP Compliance/Process Awareness Male Candidates & Biologics Company's only Preferable. "IMMEDIATE JOINERS ARE PREFERABLE"

FQC control. Layout inspection Quality MIS Process audit PPAP documents Customer complaint closing PQCS ,PFMEA Follow up Customer Quality issue. In-Process Quality control. Uppdating list of BOP Parts. Required Candidate profile FQC control. Quality documentations. NPD Parts inspection. In process failure escalation.

Role & responsibilities Development of Quality Assurance process and quality system. • Quality Management systems • Failure analysis and Initiating Corrective action. • Knowledge of Incoming Inspection, In-process Inspection and Final Inspection • Knowledge of Statistical Process Control, Measurement system analysis & PPAP submissions and preparation of FMEAs • Prior working on Automotive Products • Handling of Automotive OEMs • Trained QMS Auditors and knowledge of Internal audits and coordinating with third party QMS auditors • Knowledge on handling mechanical instruments and calibration activities • Acquainted with handling of periodic NC review meetings(Vendor/Internal) & DRMs • Knowledge on continual process improvement, 5S & Japanese Quality management systems • Knowledge on SAP QM module • Communication and interpersonal skills • Training and development of employees

Manage overall Quality (Supplier Quality, Product Quality, Customer complaints), Audits(IATF, Customer, supplier, process etc) Product / Process improvements through Kaizen. Compliances to 5S & Safety. Training and skill building of Team.

Reporting to - General Manager Deputy Manager/Manger - Plant Operations Quality Role & responsibilities Ensuring the products leaving the Plants are having near zero Quality defects. Ensure availability of calibrated instruments/gauges and ensure handling of NC products Ensure internal and Customer CAPA made on time use 8D/A3 and reduce COPQ. Maintenance of QMS documents where applicable and bring Improvements. Preparation of quality Plans and Authorized to release the products. Ensure Timely submission of PPAP and Ontime Customer audit actions closure. Plan and conduct internal audits related QMS, EMS & OHS as needed Maintain compliance and organization performance data every month. Ensure all operations are planned, controlled, Implemented as per procedures. Achieve Plant specific Quality KPIs along with YoY improvements. Execute Quality Improvement Projects -be Quality expert with an ability to lead and guide team. Ensure the deployment of Quality tools PFD/PFMEA/CP/SPC/MSAetc. Develop Team members, keep talent pipeline, others as per business need. Problem solving and bring the CI culture within department and organization. Strong in Quality and Production documentation and records maintenance. Preferred candidate profile Should have handled all the Quality area with minimum 10 Inspectors. Knowledge on Problem solving, 8D/A3 and other tools, Agile and Proactive. ISO 9001:2015 LA or Good Process audit and System audit exposure. ISO 14001/ ISO 45001 Knowledge/ Implementation experience is advantage. Educational Qualification - BE/Diploma in Mechanical engineering / Industrial engineering / Production engineering Total years of experience - 8 -12 years of experience Industry - Industrial packaging, Corrugation / Manufacturing If you are passionate about quality excellence and driving continuous improvement, we encourage you to apply for the position posted above. Join us in our mission to deliver high-quality products and exceed customer expectations.

IATF Requirements as per Company's Standard, BIS Audit, Customer complaints & Handling , Glass Process Inspection Analysis & Knowledge, Related Lab Responsibility & Testing

To ensure that process is carried out as per system and customer requirements. Handling customer complaints and monitor organization has met customer requirements. Responsible for yield at various stages of production processes. Authorized to stop the process in case of non conformity and work with production and process development for solutions. To ensure that identification and traceability are maintained as per requirements. Track issues, get corrective actions and ensure the closure. Raise internal NC report and ensure the closure and effectiveness. Actively participate on ECP meetings, APQP meetings and Customer complaint meetings and ensure it is effectively implemented in line. Organize Operational meetings and Quality review meetings (for yield improvements) and track actions for closure. To learn current updates and developments in the field. To perform continual improvement projects and give suggestions for improvements. Quality point of contact for any customer concerns. Recording customer complaints and acknowledge the customer with containment actions. Analysis with cross-functional team with the help of quality tools Plan corrective and preventive action against customer complaints together with the related departments. To effectively follow-up the action items related to customer complaints and ensure effective closure. To review and initiate for any process / engineering / document changes wherever necessary. Update 8D report and send to customer. To monitor and audit the effectiveness of the corrective and preventive actions. To review the RMA request from customers, Allocate RMA number and communicate to customers. To arrange / attend RMA meetings, analyze RMA rejections, plan corrective actions and to keep data, track and close the loop. To visit customers as and when required for warranty rejection analysis as well as customer complaints.

Reporting to - General Manager Deputy Manager/Manger - Plant Operations Quality Role & responsibilities Ensuring the products leaving the Plants are having near zero Quality defects. Ensure availability of calibrated instruments/gauges and ensure handling of NC products Ensure internal and Customer CAPA made on time use 8D/A3 and reduce COPQ. Maintenance of QMS documents where applicable and bring Improvements. Preparation of quality Plans and Authorized to release the products. Ensure Timely submission of PPAP and Ontime Customer audit actions closure. Plan and conduct internal audits related QMS, EMS & OHS as needed Maintain compliance and organization performance data every month. Ensure all operations are planned, controlled, Implemented as per procedures. Achieve Plant specific Quality KPIs along with YoY improvements. Execute Quality Improvement Projects -be Quality expert with an ability to lead and guide team. Ensure the deployment of Quality tools PFD/PFMEA/CP/SPC/MSAetc. Develop Team members, keep talent pipeline, others as per business need. Problem solving and bring the CI culture within department and organization. Strong in Quality and Production documentation and records maintenance. Preferred candidate profile Should have handled all the Quality area with minimum 10 Inspectors. Knowledge on Problem solving, 8D/A3 and other tools, Agile and Proactive. ISO 9001:2015 LA or Good Process audit and System audit exposure. ISO 14001/ ISO 45001 Knowledge/ Implementation experience is advantage. Educational Qualification - BE/Diploma in Mechanical engineering / Industrial engineering / Production engineering Total years of experience - 8 -12 years of experience Industry - Industrial packaging, Corrugation / Manufacturing If you are passionate about quality excellence and driving continuous improvement, we encourage you to apply for the position posted above. Join us in our mission to deliver high-quality products and exceed customer expectations.

Working in Sheet Metal forming e.g CNC Punching/Fabrication work/Assembly of machines b preferred.Familiar with lean manufacturing process & Practices.Monitoring Productivity.Conversant with manufacturing excellence concepts viz 5S,QMS Tools Required Candidate profile Awareness of IMS(Integrated Managmnt Systems)/ ISO 9001 & ISO 14001& ERP related 2 Materials.Responsible for ERP implementation/Safety/Quality & Energy Mgmnt.Maintain periodic MIS 4 production.& CAPA

Quality Assurance & Control (QA/QC): Oversee the execution of QA/QC activities during repair, service, troubleshooting, maintenance, and overhauling of equipment, ensuring adherence to CAT III and CAT IV requirements. Review customer specifications and ensure that all quality processes align with the defined requirements. Monitor and validate service execution processes to maintain the highest quality standards. Collaborate with the operations and engineering teams to resolve any quality-related issues. Inspection and Testing: Perform dimensional checks, visual inspections, and Non-Destructive Examinations (NDE) in compliance with customer specifications and industry standards. Prepare and execute inspection and testing plans (ITPs), ensuring that all testing procedures meet the necessary standards. Analyze testing results, identify non-conformances, and recommend corrective and preventive actions. Maintain and calibrate inspection tools and equipment as required. Compliance with Standards: Ensure compliance with API Specification Q2 (Second Edition), ISO 9001:2015, and other applicable industry standards. Support internal and external audits, including customer, third-party, and regulatory audits. Assist in the development and maintenance of the Quality Management System (QMS). Health, Safety, and Environment (HSE): Conduct risk assessments and develop mitigation plans to ensure workplace safety. Implement safety procedures and policies to minimize risks and promote a safe working environment. Monitor and enforce compliance with local and international HSE regulations. Conduct regular HSE training for employees and contractors. Documentation and Reporting: Prepare detailed inspection reports, non-conformance reports, root cause analyses, and corrective action plans. Maintain comprehensive records of QA/QC activities, test results, and safety compliance documentation. Develop and implement quality and safety performance metrics to track improvement areas. Continuous Improvement: Identify opportunities for improvement in QA/QC and HSE practices and develop strategies to enhance performance. Collaborate with cross-functional teams to drive continuous improvement initiatives. Stay updated on industry trends, standards, and regulatory changes, and implement best practices accordingly. Qualifications and Skills: Technical Qualifications: Minimum 5 years of experience in QA/QC, inspection, and HSE roles within the oil and gas or industrial sector. Proven ability to conduct QAQC activities, dimensional inspections, visual inspections, and NDE testing. Familiarity with CAT III & CAT IV requirements for repair, troubleshooting, maintenance, and overhauling. In-depth knowledge of API Specification Q2 (Second Edition) and ISO 9001:2015. Certifications in NDT methods (e.g., Level II in PT, MT, UT) are highly desirable. Experience with inspection and testing tools and equipment. Soft Skills: Strong attention to detail and analytical skills. Excellent communication and interpersonal abilities for effective collaboration with teams and clients. Proficiency in documentation and reporting, with a focus on accuracy and clarity. Ability to handle multiple tasks and meet deadlines in a fast-paced environment. Proactive and self-motivated, with a commitment to maintaining high standards of quality and safety. Key Performance Indicators (KPIs): Compliance rate with QA/QC and HSE standards. Number of non-conformance issues identified and resolved. Accuracy and timeliness of inspection and testing reports. Improvement in safety performance metrics. Successful completion of internal and external audits.

a. Qualification : - D.M.E+ MBA/ B. E. Mechanical b. Experience :- 2-4 Years c. Profile : - Customer Specific Requirements, Sustainability, Environment Social Governance/EHS d. Ready to locate in Vadgaon area Required Candidate profile a. Qualification : - D.M.E+ MBA/ B. E. Mechanical b. Experience :- 2-4 Years c. Profile : - Customer Specific Requirements, Sustainability, Environment Social Governance/EHS

Urgent Required Maintenance Engineer in MNC for Chakan Pune. Required Qualification: Diploma/ BE- - Electrical/Electronics/Mechatronics Required Experience. - 2 Yrs. To 5 Yrs. Role & responsibilities Responsible for taking care of Breakdown, preventive and Predictive Maintenance. Responsible for break down analysis, countermeasure and implementation of action spare management and reporting to manager. Monthly PM Adherence as per planning. Responsible for Utility maintenance as well as plant maintenance. Coordination with shift technicians and support to eliminate down time. Verification of each breakdown. To implement safe working conditions and practices so as to achieve zero accident consistently. To ensure STP operation as per legal compliance To promote suggestion, 5S, energy saving activities to improve overall performance of plant. Maintain QMS, EMS & IATF system in department To ensure project activities as per plan & report Maintenance Manager Any accident happens counter measure on it & implementation & information to department Head. Preferred candidate profile Canteen facility is available Perks and benefits -Maintenance dept. in Electrical/ Electronics or Automotive industries. -Handling Moulding Machine's, Utility & Assembly machines

Position: Executive R&D Quality, CMC QA _ Commercial QA Support Grade: G12A Job Location: Vadodara Job Responsibilities: (PE Center) 1. Review of protocol/reports (Pharmaceutical Equivalence Report and Comparative Dissolution Profile Report) and other analytical documents related to Pharmaceutical Equivalence (PE) Center. 2. Review of QMS documents (Out of Specification/ Lab event/Planned deviation /Un planned deviation/Investigations/ CAPA/Change control). 3. To assist in developing procedures / quality system and assure compliance of the same by identifying gap through document review and Audits. 4. Review of SOPs for the compliance of the cGxP requirements and monitoring its implementation. 5. To provide support for computerised systems implementation into PE center and act as Process Quality Lead (PQL) for Validation of computerized system. 6. Review of documents, approve discrepancy note and handle quality activities of Medicinal Product Store. 7. To assess the compliance level of PE center through Self Inspection / Internal Audit program. To support all time readiness for successful regulatory inspection at PE center. Desired Candidate Profile: M. Pharm / M. Sc. with 5-7years of experience in manufacturing QC / R&D Quality involved in GMP operation. Worked in GMP area and well aware about GMP requirements for as per FDA, ANVISA, HC. Good oral and written communication skill Shall be well versed and have experience on quality management system, review of AMV, AMT, PE Certificate, CDP Report, qualification, and analytical raw data review. Shall be well versed with OOS, OOT, Investigation, Deviation, CAPA management & ANVISA PE center requirement

Role & responsibilities Gopalan Metals India Pvt Ltd is a rapidly growing manufacturer of high-quality Oxygen free copper (OFC) rods, Annealed Copper rods and Wires,strategically located in the Hoskote Industrial Area. Our state-of-the-art manufacturing facility spans 1 acre and is equipped with advanced machines ensuring precision and efficiency in our production processes. We specialize in producing top-quality copper rods, bare and tinned copper wires, bus bars crafted from EC-grade copper (99.99% purity) renowned for its superior conductivity and durability. We are looking for Manufacturing team like Production Manager , Production Engineer , PPC Engineer , Quality Engineer , QMS head for implementation and other manufacturing team for our newly established plant . Manufacturing of copper rods and wires , production control , production planning , QMS system implementation Preferred candidate profile Perks and benefits CTC + Medical Insurance + Transport + Canteen and other statutory benefits

The ideal candidate will ensure that all products meet industry standards and comply with regulatory requirements Develop and maintain procedures to comply with external regulations (ISO, GMP, FDA) Lead audits and inspections for regulatory bodies Required Candidate profile Knowledge about ICH, USFDA, WHO , PMDA Japan, EDQM, guidelines. Technical knowledge on data review for FG, BMR, Stability Data, RM, Method validation Change control, CAPA, Incidents, OOS, OOT.