6 Qms Documentation Jobs

Role & responsibilities Sr.Executive : QMS & engineering documentation Primary Responsibilities: 1. Responsible for GMP compliance, as per procedures define and implementations of GxP practices. 2. To ensure the GDP and data integrity in routine/daily activities/operations. 3. Responsible for QMS documents related to engineering. 4. Audits & compliance 5. Preparation of SOPs, review & periodic revisions 6. To attend /or supervise all jobs related to Electrical/ Instrumentation Engineering activities at site. 7. Timely execution of equipments/instruments as per schedule coordination with user. 8. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 9. Maintain the Spare parts of all critical Instruments in site. 10. Timely execution and completion of Validation/ Qualification activities at site. 11. Execution of all In-house Projects in Electrical/ instrumentation in site. 12. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Preferred candidate profile

Ensure the adherence of Supplier Quality and In-coming Quality Maintain Incoming parts quality, supplier monitoring and supplier audit Be Part of CFT to have concrete AOI development with CD team during development. Evaluate supplier product quality on regular basis and guide them to achieve consistency in quality. Participate in supplier CAT Meeting. Preparing and implementing supplier wise annual audit plan to improvement and evaluate the suppliers Analyzing the audit report and action plan from supplier for closing NCs Issue Supplier notification for quality issue, debit etc. Adherence of quality systems at In-process Quality Conduct the Internal audit of product & Manufacturing Processes and taking necessary corrective & preventive actions to prevent occurrences. Review Layout testing and Functional testing for production process. Enforce First off, last off, In-process product audit, control charts are implemented. To ensure the Identification and traceability of parts during process and supplies to customer. Maintain the QMS at Plant Provide the details of Customer QMS requirements to Employees Planning internal audit, coordinate to conduct management review meeting (MRM) & prepare minutes of meeting for necessary actions. Carryout IATF internal audit as per plan in coordination with BU QMS lead. Maintain QMS documents legibility & availability. Implement Inspection standard and work instructions related to all QA process Timely submission of revalidated reports and maintain layout inspection records etc. Preparing the plan for process, product and poka-yoke Audit and analyzing audit report. Preparing observation NCs report & tracking and verifying the actions against the NCs to ensure timely closure. Achieve Zero defect out-flow to Customer Control of master sample & revalidation. Promote awareness of customer requirements throughout the organization. Participate in APQP process. Establish Quality control measures at the identified critical control parameters. Ensure enough lighting is there in applicable parts checking area. Control on outsourced processes. Provide and check use of required PPEs to Shift Inspectors. Set the competitive targets for Inspectors to improve Quality and productivity Up-keeping available facility at Quality Lab Monitor the calibration of measuring instruments as per plan Controlling of measuring and testing equipment To follow on testing with outside lab & maintaining the QA lab. NPD Quality Review control plans (Pre-launch and full production) and identify product design and process concerns during product planning stage. Cross verify the documents (Setup approval/first piece approval/in process inspection/ final inspection/ dock audit) Develop action plan to reduce vital RPNs through ME team (Above set baseline) Be active member in CFT for development of Process documents during the Product Planning process (Gate 0) and all steps of DFMEA Participate as CFT member to Calculate the SOD (Severity x Occurrence x Detection) number or risk priority number (RPN) as part of PFMEA Communicate the importance of the implementation of QMS procedures to NPD (Program Management) and ensure alignment to VQS Ensure the entire new product development process has quality assurance built in every step Maintain the Customer Quality, Customer Complaint handling & IHR Attending customer complaint & analyzing defect/abnormality as per customer feedback & keeping documentation of corrective measures. Taking contentment action at customer end, warehouse & BSR. Doing root cause analysis & preparing action plan for taking corrective measures & horizontal deployments. Updating the corrective measures in FMEA Reporting to customer on process side & inspection side corrective action Improve PPM at customer ends. Participate in CAT meeting and reporting the action taken in timely manner to management and customers. Attending planed /surprise customer audit. Maintaining shop floor activities as per Customer Audit Check sheet in order to maintain customer audit score, product and process quality as per customers standard requirement (CSR). Preparing and implementing actions as per audit report observation and ensure timely NC closure. Maintaining warranty/EFR signoff documents and analyzing the same on timely intervention Maintaining Inspection agreement/ CSR and educating team on the same Monitoring inspection activity as per inspection agreement at final inspection along with Customer Specific Requirement. Monitoring SPC (Statistical Process Control) Monitoring & Improving process capability for product characteristic by using SPC toll to reduce variations. Conducting SPC study of process, setting control limits & training operators to use the same Employee Training & Development Conducting training as per the IATF & QMS requirement. Documenting employee skill & responsibility matrix and training employees for skill improvement. Awareness training to QA Engineers on SPC, MSA & PPAP. Ensure Employee involvement through Kaizen competition by involvement of all QA employees. Job Requirement Minimum 10-12 years of experience Industry Related experience: Auto Component Manufacturing

Role & responsibilities To manage Quality management system (QMS) in accordance with the Stellantis Quality Policy & Framework To Roll out the QMS standards and ensure the training and implementation in respective domain To assess the maturity of the QMS in all domains based on existing on-field practices To identify and prioritize audits needs depending on customer risks, regulatory requirements and the QMS maturity and guarantee the outcome of the corrective action plans, To execute yearly Audits comprising the System (IATF 16949 & ISO 9001), Start of Production readiness, Conformity of Production & Specific Audits, including closure of non-conformities. Liason with the external certification bodies for IATF 16949, ISO 9001 for closure of Non-conformities To manage the QMS Documentation Repository comprising all Domains To Coordinate for Corporate Documentation Review Meeting with all relevant Stakeholders To coordinate for preparation of Quartely QMS Synthesis to Corporate team To ensure the implementation of Laboratory Management System. To coordinate for preparation of Weekly, Monthly, Quartely QMS Management reports Preferred candidate profile Knowledge in propulsion (engine and transmission) process Engineering Graduate / Diploma in Mechanical / Automobile / Industrial Engineering, Masters degree in Quality Management is an added advantage. Having expertise in QMS domain from Automotive OEMs with 2 to 5 year’s experience Certified Lead auditor for ISO 9001:2015, Certified Internal Auditor for IATF 16949:2016 Good level of Vehicle & Powertrain Manufacturing process knowledge Excellent in communication skills with fluency in English and Malay Great autonomy in working - anticipating and driving his / her own tasks forward – action oriented Strong managerial courage towards organizational transformation, Core competent in QMS Standards & Auditing Process

Role & responsibilities 01 Quality Control Functions: 1.1 To ensure that the laboratory carrying out its testing, calibration, validation and all other technical activities in such a way to meet GLP requirements. 1.2 To carry out all technical activities and implementation of documented quality system. 1.3 To plan, schedule and monitor analysis of Raw Materials, Premix, Packing Materials, In-process materials, Finished products, Microbiological analysis, Water analysis and ensure that they meet defined relevant quality standards. 1.4 Periodically review logbooks, reports and test protocols related to Raw Materials, Premix, Packing Materials, Microbiological analysis, In-process and Finished products for proper entries, accuracy and completeness and ensure that they meet defined relevant quality standards. 1.5 To handle Quality management events according to SOP and complete its documentation with corrective and preventive actions. 1.6 To ensure that updated Specifications, Standard Testing Procedure, Test protocol and documents are available for use. 1.7 To review the resources of Manpower, Instruments, Equipment, Material and advise Management on the provision with justification. 1.8 To train the personnel in the department regarding Chemical Testing, Instrument qualification & current regulatory guidelines. 1.9 To establish effective communication systems with other departments including Commercial departments to achieve effective and efficient service from Quality Control Department. 1.10 To ensure implementation of cGMP in laboratory. 1.11 To ensure Qualification, Annual Maintenance and Calibration of QC instruments. 1.12 To ensure Management of Standards, Chemicals, Reagents and Glasswares. 1.13 To Review and approval of new or revised SOPs. 1.14 To handle instrument troubleshooting and interact with service Engineer in case of instrument breakdown. 1.15 To ensure compliance of Laboratory safety practices and firefighting devices. 2.0 General function 2.1 To provide compliance of Audit observations. 2.2 To take adequate measures to ensure updating of information and knowledge of the key people in the Quality control. 2.3 To provide support to planning, production, finish product for timely release of the goods for dispatch. 2.4 To monitor the microbiological analysis and ensure that all testing is carried out. 2.5 To create SOP awareness by continuous training. 2.6 To ensure good housekeeping of laboratory and up-keep of laboratory. 2.7 Self-updation of current regulatory guidelines. 2.8 Self inspection of other departments, as and when scheduled. . 2.9 Take necessary measures to prevent accident/incident and help in accident/incident Investigation. 3.0 Adherence and compliance to cGMP requirements. 3.1 Undertaking any other work, either for this department or any other department which the organization, which may be requested by the Plant Manager, for which training and/or an explanation has been provided and understood.

Good knowledge of QMS, Change control , Deviation. Having knowledge of Validation, APQR and other qulaity complience. Quality Management System (QMS) Implementation and Maintenance: Assist in the development, implementation, and maintenance of the QMS. Ensure compliance with relevant quality standards (e.g., ISO 9001, GMP). Maintain and upadate QMS documentation, including procedures, work instructions, and forms. Quality Control and Inspections: Conduct inspections and tests of products, processes, and materials. Identify and document non-conformances and deviations. Monitor and analyze quality data to identify trends and areas for improvement. Auditing and Compliance: Conduct internal audits to ensure compliance with QMS and regulatory requirements. Participate in external audits conducted by regulatory agencies or customers. Prepare audit reports and follow up on corrective actions.

1. Responsible for Raw material testing, In process Inspection, Final Inspection & PDI 2. Responsible for Customer Quality and timely calibration of various instruments 3. Candidate have exp in quality inspections, audits,failure analysis, QMS documentation, and team leadership, ensuring adherence to ISO, IATF, CSR to drive operational excellence. 4. Prepare the rejection & Scrap details on Daily/Monthly basis & Do analysis to control the rejection. 5. Handling Customer Complaint & Making 8D (Internal& External) to avoid thecomplaint. 6. Having Knowledge of 7 QC Tools, 5 Core Quality Tools and Maintaining MIS, Defect Analysis, Customer Complaint & find out the root cause & analysis the same to achieve targets.