369 Audit Documentation Jobs - Page 6

Roles and Responsibilities Conduct quality audits, inspections, and reviews to ensure compliance with ISO standards and company policies. Develop and implement quality control procedures to maintain high-quality products and services. Collaborate with cross-functional teams to identify areas for improvement and implement corrective actions. Ensure accurate documentation of all quality-related activities, including audit reports, records, and reports. Provide training on quality systems, processes, and procedures to employees at all levels. Desired Candidate Profile 3-8 years of experience in a similar role within the engineering & construction industry. Strong understanding of QMS (Quality Management System) principles and practices. Excellent communication skills for effective collaboration with stakeholders across various functions. Ability to analyze data from customer audits, identify trends, and develop action plans for improvement.

Role & responsibilities We are looking for highly skilled and process-driven professionals to join our Quality Assurance (QA) team at a cutting-edge surgical gloves manufacturing facility. The ideal candidate will play a key role in ensuring that every aspect of production especially raw material evaluation , packing material testing , process validation , and regulatory compliance meets stringent national and international standards for Class B, C and D medical devices. Quality Management System (QMS): Design, implement, and monitor QMS as per ISO 13485 and MDR 2017 . Maintain SOPs, work instructions, and controlled documents. Regulatory Compliance: Ensure adherence to CDSCO regulations , BIS 13422 (Surgical Gloves), BIS 15354 (Examination Gloves), and GMP guidelines. Support during audits (internal, external, and regulatory). Validation & Process Control: Oversee validation protocols including cleaning, packaging, and sterilisation (ETO/Gamma). Conduct risk assessments , change control , and CAPA implementation. Batch Records Review: Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) . Ensure traceability from raw materials to finished goods using batch/lot numbers. Packaging Material Testing & Traceability: Verify and test all packaging materials against relevant standards. Maintain Certificates of Analysis (COA) for inward materials, including packing components. Ensure complete traceability for raw materials , packaging , and finished gloves . Training & Documentation: Conduct training on QA procedures, GMP, and regulatory updates. Manage deviation reports and QA documentation flow across production and QC. Mandatory Requirements: Prior experience in a CDSCO-approved manufacturing facility handling Class B, C & D medical devices. Strong understanding of: ISO 13485 MDR 2017 BIS 13422 / BIS 15354 GMP/QMS documentation Hands-on with internal audits, regulatory inspections, and validation processes. Inward Raw Material Testing: Evaluate incoming latex and other input materials using lab instruments such as viscometers, tensile testers, hardness testers, etc. Test and verify packaging materials as per standard requirements. Attach and maintain Certificates of Analysis (COA) for all inward materials, including packaging materials. Sample Preparation: Prepare glove samples for technical evaluation, customer trials, and tender submissions. In-Process Quality Checks: Monitor ongoing production to ensure compliance with defined AQL levels and physical parameters. Identify and classify critical defects during manufacturing. Packaging & Sterilization Checks: Conduct QC checks at all packing stages: Valeting, Pouching, and Sterilization (ETO/Gamma). Verify packaging integrity and labeling accuracy. Final Product Inspection: Perform thorough inspections of finished goods, including Pre-Dispatch Inspections (PDI) . Traceability & Documentation: Maintain batch and lot numbers for raw materials, packing materials, and finished goods to ensure full traceability. Generate daily QC reports, maintain batch records, and ensure proper documentation flow. Preferred candidate profile Education: B.Sc / M.Sc in Chemistry, Microbiology, or Polymer Science OR B.Tech in Chemical Engineering, Rubber Technology, or Biomedical Engineering Experience: 37 years in QA roles within the medical devices industry (gloves manufacturing preferred) Skills: Proficiency in QA documentation , process audits , and compliance systems Experience with ERP tools (SAP or equivalent), Excel , and root cause analysis Familiarity with AQL standards , though not primary in QA, is a plus Proficiency in using QC lab instruments and interpreting test results Familiarity with Excel , ERP systems (SAP or equivalent) Knowledge of internal audits , root cause analysis , and process validation

JD - Quality control All parts to be inspected and dispatched in stipulated timeline Responsible for clearing the parts by regular follow up with customer Reducing of machine setup and stage inspection time to avoid machine idle time More Usage of laser tracker to avoid machine setup and final inspection duration Monitoring for clearing of incoming materials Monitoring for inspection & test status of incoming materials Responsible to prepare the final inspection report Responsible for customer satisfaction Reviewing and approving Inspection activities in team Implementation of QMS as per AS9100 Rev D, NC Follow ups & Root cause & corrective actions reviewing. Vendor development, Supplier Audits. Prepare Quality control plan, QAP, PFMEA Customer Handling in Inspection activities Follow ups in Calibration process Key Performance Indicators to be achieved by the role holder include Reduction in Rejects at Customer end: 0 In process rejection rate: below 5% Final rejection: Below 5% On time FAI : 100% Control of rejections : No. of Kaizens:6 Timely closure of all Non-conformities Zero accidents Directly involving with customers Preparation of Control Plans, Final Inspection reports and verifying CMM programs Gauge planning for new drawings Reviewing Route Card and releasing for all new FAI parts Ensuring complete in-process quality control with 1st off approval Interpret engineering drawings Responsible to quality problems, Handling of in-house NC Providing Root cause & Preventive and Corrective action (RCCA) through Why Why Why analysis & Fishbone diagram. Use of statistical Techniques SPC,7 QC TOOLS & MSA To check and approve FAI for new products and existing products on the basis of Customer requirements / Companys specifications / Drawings Process capability study of processes and machines (SPC) Customer complaints analysis, implementation and follow up Monitoring monthly PPM & OTD Involvement in Project Management of FAI Took part in Cross Functional activities. Conducting Configuration management audit Voluntarily conducted training based on FOD & 5S Undergone the training of AS9100 Rev D, GD&T, SPC, MSA, FMEA,7 QC TOOLS, IDENTIFICATION & TRACEBILITY, INTERNAL AUDIT MRs role in QMS Planning Context of the organization and interested parties Determining, monitoring, and reviewing risks Aligning strategies and the Quality Policy, Objectives, and Action Plans Identifying, planning, and managing processes and process changes The MRs Role during QMS Implementation Ensuring resources are determined, provided, and maintained What should be monitored and measured Engaging people through effective delegation and team approaches The MRs Role in QMS Maintenance MR role in CSM, process and product measures, internal audits Overview of the internal audit process Root cause analysis and corrective action planning tools Reviewing the effectiveness of Corrective Actions Updating the Risk Register Conducting Management Reviews The MRs Role in QMS Improvement Ensuring QMS business integration through ISO 9001:2015 Improvement of quality processes and meeting your customers needs Promoting decision making based upon evidence and data Monitoring of processes to improve efficiency, and productivity A Reduction in the three forms of waste and scrap costs. Supporting and encouraging a culture of continuous improvement Active risk assessment of designs and processes and effective mitigation practices Consistent compliance to regulatory, safety and reliability requirements. Enhancement of your corporate image in the global marketplace. Be accountable for the success and support of the QMS Integrate the QMS into the organizations regular business processes Ensure that all product, safety, and regulatory requirements are defined and understood. Promote risk based thinking and use of the process approach Establish a quality policy and objectives aligned with corporate strategy Ensure that the quality policy is available for review and maintained Provide adequate resources for implementation and continued support of the QMS Encourage associates to become engaged in the QMS and contribute to its success Foster a culture of continual improvement within the organization. Top management of the organization must assign responsibility and authority for supporting, reporting and maintaining the QMS. Furthermore, leadership of the organization is required to assign responsibility and authority for ensuring that the QMS conforms to AS9100D requirements and for regularly reporting the QMS performance results. Just like any other endeavor, the development and implementation of an AS9100 compliant QMS requires proper planning. During the planning phase, top management must consider multiple factors. Management must consider the context of the organization along with any and all interested parties. In addition, management must determine the scope of the quality management system, and take proactive measures to ensure the QMS is capable of achieving its desired objectives. Plans must be developed and implemented to provide sufficient support and resources necessary to achieve continual improvement of the QMS Adoption of new methods and practices to improve quality Development and introduction of new products or product lines Increased market share or moving into new markets Utilizing new technology within the organization

A Fabrication Quality job focuses on ensuring products meet established quality standards throughout the fabrication process. Location - Chakan, Pune Contact -Miss Maya Ma'am 9767897450

Develop and maintain QMS documentation. Conduct internal audits and support external audits to ensure compliance. Initiate and track corrective and preventive actions. Ensures compliance As per the industry standards (ISO)

Role & responsibilities : Ensuring the Execution of PM as per Plan. Implements of Kaizens, poka yoke for down time, Cost reduction & quality improvement. Reduction in spare parts cost. Root cause analysis & implementing of actions. Hand on experience and technical skill weld shop-Seam & Spot welding machine, Robotic MIG & Spot welding cell for trouble shooting. Knowledge of IATF, EMS/OHS & SAP Requirements. Responsible for reducing down time and power cost in weld shop area. Attend the breakdown in Weld shop & CED Area. PLC & HMI fault analysis Mitsubishi preferred. Read & understanding of Electrical drawing & Circuit

-Manage AP/AR, budget & reporting -Handle global tax compliance (India, US, KSA, Kenya) -Liaise with legal/tax/bank/insurance consultants -Lead audits, organize documentation, maintain business integrity -Track revenues, WIP, P&L across verticals Required Candidate profile -Maintain fixed asset register, insurance, payroll finance -Drive Cost control,Cash flow,Monthly variance -Strong Financial reporting, Compliances -MS Office/Zoho Books -Excellent Communication skills

Role & responsibilities Post- Senior Quality Engineer Skills - ISO & IATF audits, and BIS Certification also. Industry - Metal Aluminium Extrusion Location - Ahmed Nagar , Bhalwani Parner roa d Education BE DME Exp - 08-10 yrs Contact - 9356395439 JD Oversee Quality Management System • Report on Quality Metrics • Identify Safe Working Environment Protocols • Root cause and corrective action plans • Establishing standard operations procedures • Analytical skills • Responsible for organizing and managing the activities of receiving in process and outgoing quality functions • Handling customer complaints and taking corrective action plans. • Knowledge about to handling ISO & IATF audits, and BIS Certification also.

ISO Standards Compliance Quality Assurance Auditing Process Documentation and Control Six Sigma and Continuous Improvement Quality Metrics and Reporting Risk Management

Job Purpose: Coordinate and maintain the organizations ISO management systems, ensuring ongoing compliance with international standards such as ISO 9001/ IATF 16949 2016, ISO 14001, ISO 45001, ISO 37001, and others as applicable. The role involves document control, audit management, nonconformance tracking, and supporting continual improvement initiatives. Key Responsibilities: System Maintenance & Coordination - Ensure implementation and continual improvement of ISO standards within the organization. - Maintain the Integrated Management System (IMS) documentation, procedures, and records. - Facilitate cross-functional compliance with all ISO and legal requirements. Internal Audits - Plan and coordinate internal audits across all departments. - Maintain the internal audit schedule and follow up on audit findings and corrective actions. - Liaise with external certification bodies and support during external audits. Document Control - Manage the creation, review, revision, and distribution of controlled documents. - Maintain a central document register and ensure access to current versions. Compliance & Risk Monitoring - Support compliance with anti-bribery requirements under ISO 37001. - Maintain registers for risks, opportunities, legal compliance, and anti-bribery concerns. - Promote awareness of compliance obligations across departments. Training & Awareness - Support training initiatives on ISO standards, procedures, and compliance requirements. - Organize inductions and awareness sessions for new employees and existing staff. Non-Conformance & CAPA - Monitor nonconformities and ensure effective root cause analysis. - Track corrective and preventive actions to closure. Management Review - Assist in compiling data and reports for Management Review Meetings (MRM). - Maintain MRM records and track action items for closure. Key Skills & Competencies: - Strong understanding of ISO standards (9001, 14001, 45001, 37001, etc.) - Knowledge of compliance, risk, and document management. - Good organizational and communication skills. - Proficiency in MS Office, audit tools, and document management systems. - Analytical and problem-solving skills. Education & Experience: - Bachelors degree in Engineering, Science, or a relevant field. - ISO Internal Auditor certification is mandatory. - Minimum 3 years of experience in ISO systems implementation/coordination. Performance Indicators: - Timely closure of internal audit findings - Maintenance of up-to-date controlled documents - ISO certification compliance status - Timeliness of management reviews and risk updates - Staff awareness/training levels

Responsible for Quality Assurance , documentation , Audits , ISO 13485:2016, RA

Responsibilities: * Conduct quality inspections using raw materials, final products & processes * Perform SPC, Why-Why analysis & Poka Yoke implementation *Good Understanding of Documentation *Spectro Handling * Shift Handling Annual bonus Health insurance Provident fund

You will be joining P. B. SHETTY & CO. LLP, a leading Chartered Accountancy firm located near Grant Road Station in Mumbai. As an Article Assistant, you will have the opportunity to gain hands-on training and diverse professional experiences in various aspects of Chartered Accountancy. Your role will involve assisting in statutory audits, tax audits, internal audits, and limited reviews. You will also provide support in GST compliance, return filing, reconciliations, and audit assistance. Additionally, you will be responsible for tax return preparation, accounting, bookkeeping, and financial statement preparation. To succeed in this role, you must demonstrate a proactive learning attitude, meet deadlines efficiently, and deliver high-quality work with integrity. You will play a crucial part in supporting the firm's service delivery to clients from different industry sectors. Key Responsibilities include preparing audit documentation, conducting research on income tax/GST notices, and effectively communicating with clients and team members. You should have passed CA Intermediate (both groups or at least Group I), possess a strong academic background, and show a keen interest in learning. Proficiency in MS Office applications like Excel and Word, as well as accounting software such as Tally, is required. Excellent communication and presentation skills are essential, along with the ability to work independently and in teams. Your role will offer exposure to diverse clients, hands-on training in various practice areas, and direct interaction with partners and senior professionals. Join us at P. B. SHETTY & CO. LLP to benefit from a structured learning environment, periodic evaluations, and the opportunity to develop professional values and ethical standards.,

Support QMS implementation and maintenance. Conduct internal/external audits, including customer & regulatory. Prepare audit docs, handle vendor/customer questionnaires. Coordinate with teams to ensure GMP. Report deviations, OOS, and assist in CAPA.

Implement and maintain QMS per GMP. Conduct audits, vendor qualification, and quality reviews. Approve SOPs, BMRs, BPRs, specs, change controls, APQRs. Investigate OOS, OOT, complaints, oversee CAPA, and ensure compliance across all departments. Required Candidate profile QMS Implementation | cGMP Compliance | Internal & External Audits | SOP/BMR Review | Change Control | CAPA | APQR | Risk Assessment | Vendor Qualification | Regulatory Compliance | Root Cause Analyse

Preparing & complying with documents as per QMS/API Q1/EMS/OHS Interaction with certification bodies for audit systems,Training to all concerned in management systems as well as customer specific requirements Customers audits for management systems. Required Candidate profile Candidate should have exeprience in QMS Having experience in Oil/Automotive Industry

Role Summary: The Organic Certification Executive will be responsible for coordinating and managing all activities related to organic certification, audits, compliance, documentation, and communication with certification bodies. This role ensures that all processes, farmer groups, and supply chains are in full compliance with national and international organic standards (e.g., NPOP, NOP, EU, etc.). Key Responsibilities: Coordinate with certification agencies for inspections, audits, and documentation reviews Prepare, compile, and maintain all required documents for organic certification and renewals Ensure compliance with relevant organic standards (NPOP, NOP, EU, JAS, etc.) Maintain and update ICS (Internal Control System) records, transaction certificates, and traceability documents Work closely with purchase, production, and QC teams to ensure end-to-end organic compliance Monitor and update farmer group certifications, field records, and training documentation Assist in preparing for internal and external audits, including mock audits Address and close non-compliances and observations raised during inspections Liaise with third-party certifying bodies, farmers, and internal departments for documentation and clarifications Maintain up-to-date knowledge of evolving organic regulations and standards Key Skills & Requirements: Strong understanding of organic certification processes and standards (NPOP/NOP/EU) Experience working with ICS, TC applications, and organic audit documentation Attention to detail and excellent organizational skills Good communication skills (written and verbal English & Hindi) Ability to coordinate across departments and manage documentation timelines Proficient in MS Office (especially Excel and Word) Preferred Qualifications: Prior experience with certification bodies or organic exporters Exposure to international organic regulations and audits Familiarity with sustainability standards (Fairtrade, Rainforest Alliance, etc.) is a plus Why Join Us: At Agronic Food, we are committed to sustainability, transparency, and organic integrity. As a part of our Certification team, you’ll play a crucial role in upholding these values while working with 50,000+ farmers across India and supporting exports to 24+ countries.

DME/BE - Mech with at least 10-15 years of experience in automotive industries, Knowledge of IATF 16949,VDA 6.3, Pokayoke, Kaizen. Having ERP Knowledge shall be preferred.

Quality Management System (hereinafter QMS) audit is essential for any organization that wants to ensure its products and services meet the highest quality standards. It is a systematic examination of an organization's QMS to identify areas for improvement and ensure adherence to relevant standards and regulations. Quality Manual Procedures Work Instructions Records of previous audits Importance of Document Control

Minimum 10 years of exp in auditing, compliance or operational process improvement, preferably within security services or related sectors. In-depth knowledge of BS7858 standards, including audit documentation management and process reporting Required Candidate profile Proficiency in Microsoft Excel, documentation tools, and audit reporting platforms. Master’s degree in Business Administration, or a related discipline. ACS, SIA , ISO certification

Position Summary: We are seeking an experienced and highly motivated GMP Auditor to join our Global Quality team. This role is primarily responsible for conducting GMP audits of Specialty and Biosimilar products, as well as third-party suppliers across all the global regions. The ideal candidate will have deep regulatory knowledge, strong risk assessment capabilities, and experience with inspection readiness and cross-functional collaboration. Key Responsibilities: Audit Execution & Compliance Planning, Preparing, Conducting and Reporting of GMP/GDP and Quality system audits at Third party contractors for Specialty/ Biosimilar products (Finished dosage manufacturers, API manufacturers, key intermediate manufacturers, Excipients Manufacturers, Packaging Material Manufacturers, Contract Manufacturers, Contract testing labs, Contract Research Organizations) to monitor that all aspects of the operational business comply with applicable GMP / GDP legal and regulatory requirements (e.g. National and EU requirements), and the STADA Group Quality Standard in close cooperation with the Global Quality Supplier Management & Auditing Team located at STADA Arzneimittel AG Headquarter in Germany and STADA Hemofarm SRL in Romania. Ensure compliance with EU GMP, ICH Q7, 21 CFR 210/211, and internal STADA Group standards. Prepare and distribute audit reports, review CAPAs, and ensure timely closure and KPI tracking. Conduct due diligence and qualification audits for Biosimilars/ Specialty and new CMOs. Perform Pharmacovigilance and GCP audits as required. Risk Management & Inspection Readiness Ensure global standards and processes developed and in place to support specialties/biologics Support global risk management initiatives and inspection readiness for FDA, EU, and ROW markets. Assess site issues, deviations, and contribute to resolution planning. Develop and maintain CMO risk ratings for the Global Specialties portfolio. Communicate high-risk CMOs and mitigation strategies to leadership. Inspection readiness: Participate in internal audits, CAPA evaluations, and support health authority inspections. Collaboration & Reporting Align and collaborate with other regional and global auditing teams. Support global quality improvement initiatives and cross-functional projects. Prepare monthly reports, risk assessments, and maintain KPI metrics. Contribute to the development of global standards and auditing best practices. Travel Requirements Willingness to travel across all regions Qualifications and Experience: Education: Bachelors degree in Pharmacy, Chemistry, Biotechnology, or a related field MBA from a recognized institution is a plus Professional Experience: 8–10 years of experience in pharmaceutical, biopharmaceutical, or chemical industry Hands-on experience in QA/QC, Production, or R&D functions of Specialty and Biosimilar products Proven track record in auditing third-party manufacturers in line with EU GMP and FDA regulations Strong knowledge of global regulatory requirements (EU, FDA, ICH, ROW) Skills: Excellent audit and risk assessment capabilities Strong interpersonal and cross-cultural communication skills High proficiency in Microsoft Office and auditing tools Fluency in English (spoken and written) Strong organizational and multitasking abilities Flexible and adaptable to changing priorities and deadlines

Role & responsibilities Maintain and implement QMS and EMS systems within the organization. Maintain quality and environmental Standards as per ISO-9000 (QMS) and ISO 14000 (EMS). Prepare all documents of Audit & provide control copy to each department and where ever applicable. Prepare Audit NC & take corrective & preventive action. Responsible for all Management Representative (MR) activity. Coordinate / collect data from each department and conduct MRM Meeting. Conduct internal Audit and External audit. Responsible for MPI/DP inspection, and coordinated with production team and ensure the results are delivered without delay. Responsible for all RT casting and complete follow up with RT inspection. Evaluation of RT film and interpret the test result and defect marking. Handling customer complaints / NCR and find out root cause / corrective action, and communicate to customer for closing. Conduct regular customer complaint meetings and monitor improvements. Identify key technical issues & report to HOD. Support to develop critical grades as per customer requirement (as per QAP). Support to identify supplier for Calibration of all Measuring equipment. Coordinate with production team, and work for despatch planning. Follow with special process, such as HT and welding. Give approval for carryout HT cycle and welding parameters. Develop welder qualification, and maintain welder continuity reports. Develop for WPS for new grade / existing up-gradation to customer requirements. Involve for New Product development activities. To Give training related to Audit and ISO Standard. Coordinating training programme for associates and team members. Maintain Discipline and safe working conditions. Preferred candidate profile Candidate having experience in foundry & casting with steel & Stainless steel Perks and benefits No bar for right candidate.

Responsibilities: * Maintain documents as per ISO audit point of view. * ISO based documentation and QMS maintain. Provident fund Health insurance

Role & responsibilities 1. Leading Audit Program (MACE AUDIT, IATF 16949:2016, and CUSTOMER PROCES & SYSTEM AUDIT) of the company. 2. Ensure that processes needed for Quality Management System are established, implemented & maintained (e.g., Control of documents, Internal Auditing, MRM.) 3. Ensure implementation of various types quality standard throughout the plant for new products as per customer requirement. 4. Responsible for implementation of all procedure described in quality management system. 5. Responsible for ensuring that all In-House systems and procedures are updated revise and modified to meet the external certification bodies. 6. Responsible of verification and approval for material checked by IQC during receiving of material. 7. Creating Quality awareness by conducting training for Executive/ Supervisors whose work will affect the Quality of the product. 8. Responsible for implementation of standards related to quality at supplier and verification of implemented standard through the audit at supplier. 9. Responsible for approval of material made under 4M Change and abnormal situation. 10. Responsible for submission of countermeasure against customer complaints. Preferred candidate profile QMS Engineer Perks and benefits

Job Summary: We are seeking a highly experienced and qualified Senior ISO Consultant to lead, manage, and support consultancy and audit projects across multiple ISO standards including ISO 9001 (Quality), ISO 14001 (Environmental), ISO 45001 (Occupational Health & Safety), ISO 27001 (Information Security), and ISO 37001 (Anti-Bribery). The candidate should be capable of managing multiple clients, conducting gap analysis, implementing systems, training stakeholders, and supporting external audits. Key Responsibilities: Lead and implement ISO management systems for clients across ISO 9001, 14001, 45001, 27001, and 37001. Conduct gap assessments, risk assessments, and internal audits. Prepare documentation such as policies, procedures, manuals, and audit reports. Advise clients on compliance strategies and continuous improvement. Deliver training and awareness sessions to client teams. Coordinate with certification bodies and assist during third-party audits. Ensure timely project delivery and client satisfaction. Keep up to date with changes in ISO standards and regulatory requirements. Requirements: Bachelors degree in Engineering, Environmental Science, IT, or a related field. Minimum 8 years of relevant experience in ISO consultancy or auditing. Certified Lead Auditor in ISO 9001, 14001, 45001 (mandatory). Lead Auditor certification in ISO 27001 and 37001 (preferred or willing to obtain). Strong knowledge of management system integration. Excellent communication, project management, and analytical skills. Ability to work independently and manage multiple client engagements. Willingness to travel as required. Preferred Qualifications: Experience working under ISO/IEC 17021 framework. Knowledge of local and international compliance requirements. Previous experience with certification bodies or third-party audits.