384 Iso Documentation Jobs - Page 14

Role & responsibilities Design and implement documentation for the ISO 9001:2015 Quality Management System (QMS) in relation to product standards. Fulfill the requirements outlined by the ISO 45001:2018 Occupational Health and Safety Management System (OHSMS). Assess and confirm safety clearances while ensuring compliance with safety protocols during testing and commissioning processes. Offer continuous support and direction to departmental teams to improve awareness and compliance with QMS and OHSMS standards, reinforcing a safety- and quality-driven culture. Perform internal audits across departments to verify conformity with established QMS and OHSMS procedures. Represent management in contract reviews, identifying quality-related risks and proposing appropriate mitigation plans. Develop the Manufacturing Quality Assurance Plan (MQAP) and author key documents, including Standard Operating Procedures (SOPs) for quality and safety systems. Define inspection criteria and implement Inspection and Test Plans (ITPs) to ensure product quality during the manufacturing lifecycle. Lead quality discussions and coordinate with relevant teams to resolve technical concerns, respond to customer queries, and address complaints. Monitor stage-wise and final product inspections, collaborating closely with Quality Engineers. Coordinate and manage customer and supplier inspections to ensure compliance with quality standards. Carry out safety assessments and confirm adherence to legal and regulatory safety requirements in manufacturing. Maintain proper documentation, conduct data analysis, and compile reports for top management review. Preferred candidate profile Role : Senior QMS Manager Experience - 5+ Degree: BE (Electrical Engineering or Mechanical). Software: MS Office, MS Excel.

Position- Assistant Manager Job Location - Rajasthan (Bhadra/ Sardarshahar) Qualification - B.E/B.Tech - Mechanical Engineering and MBA preferrable Experience - 2-3 years of experience into Internal Audits and Project Audits Key Responsibilities: Develop and implement an internal audit plan for different functional areas at the corporate and plants level. Conduct detailed audits of various business processes, including project management, operations, maintenance, financial, operational, and compliance areas. Perform transactional audit for key risk areas. Support the external consultants in coordination and review. Visit the different plants, as per the requirement, to assess the effectiveness of internal controls and obtain an action plan from concerned stakeholders, on the issues identified during the visit. Follow up on the status of action plan on the issues identified by consultants as well as by internal team. Conduct comprehensive internal audits of various departments and functions within the organization. Assess the adequacy and effectiveness of the organization's internal controls and risk management processes. Identify and evaluate risks and recommend corrective actions to mitigate them. Identify requirements of policy & procedures and get them developed and then get it implemented. Prepare detailed audit reports that summarize findings, recommendations, and management responses. Follow up on management responses to audit recommendations to ensure timely and effective implementation. Maintain strong relationships with stakeholders. Stay updated on industry best practices, regulatory requirements, and emerging trends in internal audit. Qualifications: Mechanical Engineer plus MBA Minimum 2-3 years of experience in project management/ project audits/ operations audit Experience in leading and managing internal audit teams. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Willingness to travel to plants when required Team player with a collaborative attitude and willingness to contribute ideas and support other team members. Prior experience in the renewable energy sector is desirable but not mandatory. Preferred candidate profile 2-3 years of experience into internal audits and project audits , who is open to Relocate to Rajasthan (Bhadra/ Sardarshahar).

Quality Control Documentation & Procedures: Create and update quality control documentation and procedures to ensure compliance and reflect industry best practices. Regularly review to keep protocols current. Lead Customer and IMS Audits: Conduct and manage customer and IMS audits, ensuring adherence to standards and promptly addressing any issues. Use audit feedback to drive continuous improvement. Real-Time Data Migration: Oversee the migration of electrical data and IV graphs to the cloud, ensuring accuracy and timeliness. Resolve any data migration issues swiftly to maintain system integrity. Calibration Module Availability: Ensure calibration modules are available and functioning properly through regular maintenance and calibration. Coordinate with teams to prevent production delays. Training and Development: Develop and deliver training on calibration and quality control, incorporating industry advancements to enhance staff skills and compliance. Promote continuous learning. Documentation and Reporting: Prepare and maintain reports on calibration and audit activities, ensuring timely and accurate documentation. Provide insights on performance metrics to support decision-making. Key Stakeholders - Internal: Calibration Team Quality Assurance Managers Maintenance Team Production Managers Key Stakeholders - External: Calibration Service Providers Certification Agencies Regulatory Bodies Suppliers

Drive end to end Internal Process Audit - Plan, Audit, Review, Follow-up, Closure across all functions in MDPL and drive the entire ISO Audit for the company Role & responsibilities End to end ownership of the ISO journey of the company and all its 3rd party vendors Review of all internal processes across all teams and publish Process Compliance Report to Senior Management Prepare Monthly reports on Process Compliance across teams and rank processes Coordinate with all functions in MDPL to track the closure of all corrective actions of all identified gaps Propose process improvement initiatives and process re-engineering initiatives basis the gaps identified in process audits Formalize Process Training Needs and Conduct relevant process trainings across teams Play a pivotal role in overall Process Excellence and Quality Management through close involvement with Process Development, Standardization, and Improvement Assist all functions in MDPL to update the requirements of all External Audits SPOC for External Audit Coordinate with all functions in MDPL to track the closure of all corrective actions post External Audit Assisting the Management Representative in all QMS activities Preferred candidate profile Experience in ISO 9001 is a must Experience in Process Improvement projects Experience in Quality Management and Process Audits Good verbal and written communication skills Eye for details in processes and systems. Excellent negotiation and stakeholder management skills ISO c Auditor certification will be an advantage Knowledge of ISO guidelines related to Quality Management, MS Office, Keen eye for detail, attention to the minute inconsistencies

Application invited for ISO & QMS Lead Auditor JOB TYPE : Freelance engagement / Consultancy Location : INTEROCEAN, Mohan Estate Industrial Estate, Near SARITA VIHAR Job Description Exposure in Implementation and maintenance of ISO 9001:2015 requirements through Bureau Veritas certification body. Conducting Internal Audits as per Audit plan Conducting Management Review Meetings as required Witnessing and getting External Audits cleared Updation of ISO system (Manual, Formats, Procedures etc.) when required. Conducting ISO Awareness trainings Guiding Staff about implementation and assisting in making records (Quality Objectives, Continual Improvement Records and related reports). Preparing all relevant (Internal Audit & MRM) records as per system requirement Travel to Port Offices and conducting Internal Audits. Skillset required: Education & Certification: Required relevant degree & professional certification or training course pertaining to ISO Standards, Quality management, Environmental Management, or Occupational Health and Safety. Interested candidates, please mail your cvs at pooja.budhiraja@interocean.in

Acquire prospective customer from food & agri industries for business. End-to-end handling of QMS.FSMS & other systems Certification for the customers which includes training, documentation, implementation & audits of prospective clients. Annual bonus Work from home Travel allowance Job/soft skill training

plastic Injection Molding. Knowledge about production process. Line balancing, cycle time and other operation of production. SIP, SOP, PPAP etc. Defect handling. Fixture & Breakdown management. IATF 16949:2016 / ISO Rejection & Overtaken control

The ideal candidate will own the entire production process during the shift. They will strategise with other internal teams to ensure operational excellence.

Role & responsibilities To Monitoring Customer Complaints & minimizing complaints through action taken. To Monitor all area PPM (Final Inspection & escalation to respective areas for improvement & provide support to achieved defined targets. Responsible for adherence of Quality management system & align with TS 16949/Customer requirements on monthly basis. Effectiveness Monitoring of Corrective & preventive action plan. Improve Customer Rating. Preferred candidate profile Btech Mechanical with 19+ years of work experience in Automotive Industry. Leadership quality, Analytical skills, knowledge of quality tools, Communication skills, Presentation skills 5 S & Safety audits

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types ofschedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standards through robust QMS implementation, audits & CAPA systems Required Candidate profile 8–12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge - ISO 9001, GMP & other quality standards

Role & responsibilities Develop 3D models and 2D drawings of tools, Jigs & fixtures, moulds, mandrels for composite components using CAD software (e.g., Autocad, CATIA, SolidWorks, NX). Conduct feasibility studies, material selection, and weight optimization for composite parts. Ensure compliance with ISO 9001, AS9100 and customer-specific standards. Create detailed technical documentation, including design reports, test plans, and validation documents. Perform structural, thermal, and fatigue analysis using FEA tools (e.g., ANSYS, Abaqus). Support Computational Fluid Dynamics (CFD) studies for aerodynamic components. Validate designs through hand calculations and industry-standard analytical methods. Coordinate with production teams for prototype development. Develop and execute testing plans to validate structural integrity and performance. Interpret test data and refine designs to meet functional and performance requirements. Work closely with manufacturing, quality, and supply chain teams to ensure design manufacturability. Develop layup schedules, tooling requirements, and process specifications for composite parts. Support process improvement initiatives to enhance product quality and efficiency. Maintain design records, material traceability, and change management documentation per ISO/AS9100 requirements. Participate in Design Reviews, Failure Mode & Effects Analysis (FMEA), and Risk Assessments. Liaise with defence customers to gather technical requirements and present design solutions. Work with suppliers to validate materials, components, and manufacturing processes. Support First Article Inspection (FAI) and PPAP (Production Part Approval Process). Preferred candidate profile BE/B. Tech(Mechanical) with 4-8 Years in Design Exp(Defense Manufacturing Industry) Hand on Experience in Auto Cad/ Solid Works

Role & responsibilities Develop and implement an integrated management system (IMS) that integrate quality management(ISO 9001), Environment management (ISO 14001), Occupational health and safety (ISO 45001), Energy management (ISO 50001) and asset management( 55001). Establish IMS policies, procedures and processes to ensure compliance with ISO requirement and regulatory. Experience in conducting internal audits, external audits and managing certification process. Coordinate with department heads to ensure alignments of processes and procedure with ISO requirements. Provide training and guidance to employees on IMS policies. Assuring safe work practice at workplace SAP Data entries related activity Proficiency in MS office suite and IMS software tools. Preferred candidate profile Candidates having experience of 4 to 8 years with Electrical Engineering background . Preference will be given to certification as ISO lead auditor.

Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance. Lead and manage the QA aspects of IT system validation activities, including document review, filing, system uploads, and approvals, ensuring compliance with relevant regulations (e.g., GCP). Maintain QA databases and electronic file systems related to IT system validation, change control, and audit trails. Oversee and maintain the IT system inventory list, ensuring accuracy and completeness of all documented systems. Independently manage the IT system change control process, including review, assessment, and approval of changes to validated systems. Provide expert advice, interpretation, and training on CSV requirements, GAMP 5 principles, and relevant regulatory guidelines Create, update and collect SOPs, templates and forms/documents. Participate in and contribute to the review and follow-up of corrective and preventive action plans (CAPAs) arising from IT system audits, deviations, and regulatory inspections. Support the Quality Assurance team in the coordination of internal and external audits, including readiness activities specific to IT systems and CSV. Assist in audit preparing activities such as Quality Assurance Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments Track and ensure compliance with timelines for IT-related quality activities, including system reviews, approvals, and training Support cross-functional teams (e.g., IT, Data Management) in ensuring the quality and compliance of computerized systems throughout their lifecycle. Manage the end-to-end process for training within the Learning Management System (LMS), including creation, assignment, and disabling of training. Contribute to the development and monitoring of Quality Key Performance Indicators (KPIs) related to IT system compliance and identify areas for improvement. Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance. Assist the Quality Assurance Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc. Any other reasonable task that derives from the previous ones or the position requires.

- Overall responsible for the quality department, manage team of 10- 12 persons - Knowledge of ISO processes/documentation and its implementation - Deep knowledge of IATF 16949 certification - Should be able to interact directly with the customers for quality related issues - Well versed in PPAP/8D reports - Should have knowledge of sheet metal parts & injection molded parts

Responsibilities: As a A Quality Management System (QMS) Engineer * Develop & maintain quality docs, including compliance with industry standards * Implement QMS,IATF, ISO standards, PPAP Process t audits. continuous improvement initiatives Provident fund Annual bonus Food allowance Health insurance Office cab/shuttle

Knowledge of sheet metals & machinery components. Knowledge of PPAP, APQP, SPC, MSA, FMEA Knowledge of ISO 9001, IATF, EMS, OHSAS knowledge of MIS data collection, MAC audit system knowledge of top management MRM Required Candidate profile Graduation in Engineering, Quality Management, or related field. Certified Lead Auditor for ISO 9001 and/or IATF 16949. Strong communication, analytical, and problem-solving skills.

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

The candidate should have the ability to work safely following standard procedures, operate laboratory polymer analysis equipment, take samples and analyse process streams samples as required, and keep the working area tidy and clean at all times. Experience with documentation, preparing SOPs, LIMS and internal and external audits like ISO would be an added advantage. Knowledge: The candidate should have knowledge of PP,PVC, Kaizen, TQM, ISO documentation, QC Safety, attend & carry out process & QC audits, and a collaborative mindset for inter and intra-departmental coordination. Knowledge of IATF, ISO, Detailed Oriented, LIMS, SOPs, SAP, Talley, 5s would be desired. Desired Exposure: The candidate should have exposure to IATF, ISOs, Audits, Complaint analysis & closures.

Role & responsibilities In Precision Engineering Close Tolerance Components & Products Manufacturing or related fields with Certification as an IATF16949 Auditor or firsthand implementation & successful accreditation of the 16949 standard is essential. Knowledge in SPC and quality tools like FMEA, PAAP is a must. Exceptional Leadership, problem solving, impart training first hand to Subordination to develop analytical skills to solve problems, a very thorough understanding of the IATF 16949 Standards to develop, implement and maintain QMS Compliances, oversee all aspects of products, process audits, inspection and testing, drive continuous improvement initiatives to enhance product quality, reduce process defects and costs significantly, lead, train and mentor the young quality teams, Set up processes to collaborate with suppliers/vendors to ensure they meet the quality requirements and standard, maintain documentation, records of Audits and Compliances with Corrective actions records and Present high quality Reports to Management and Departments as also external stake holders & Customers, highlighting key performance Indicators and time bound improvement programs that are correlated to cost & budget targets of the Division, linked to the Corporate Objective & Goals. Preferred candidate profile Inward, Line, Final Inspections & Sub-contact Inspections. Testing & Painting Total Product & Processes Quality Control. Vendor/Sub Contractors evaluation NPD Validation Design, Plan & Implementation of QMS for Certification of IATF TS16949. Conduct Management Review Meetings periodically Customer Inspections and coordination.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity.

Role & responsibilities - Understand and segregate the activities of Non-Standard orders and manage the SAR (Sales Action Request) well. Create accurate part code as per defined system in SAP Create accurate BOM in SAP Maintain the BOM and revisions in SAP Record the Non-Standard activities and derive the total execution time to understand delivery commitment. Release accurate BOM for new products and Non-Standard Orders through SAP Maintain ISO documents Coordinate with Design and Development team to execute projects and non-standard orders. Indent the part as per requirements. Update the BOM as per Design Change Request in SAP

Daily Activities Include - Pre-Order and Post Order Documentation, Prior Experience in the Valve Industry (Piping or Instrumentation), Raw material standards (ASTM, API), Calibration, Handling TPI, Prepare Procedures, ISO, API awareness, etc