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5.0 - 8.0 years
6 - 12 Lacs
Indapur
Work from Office
Develop and implement quality standards, inspection processes, and testing protocols. Oversee product testing to ensure compliance with specifications. Address customer complaints, lead failure investigations, and ensure timely resolution. Required Candidate profile A Senior QE must possess strong analytical skills, expertise in quality tools (SPC, MSA, DOE), and leadership abilities to drive a culture of quality excellence
Posted 1 week ago
1.0 - 5.0 years
35 - 100 Lacs
Bengaluru
Work from Office
Data Governance & Quality - Data Analyst Req number: R4899 Employment type: Full time Worksite flexibility: Hybrid Who we are CAI is a global technology services firm with over 8,500 associates worldwide and a yearly revenue of $1 billion+. We have over 40 years of excellence in uniting talent and technology to power the possible for our clients, colleagues, and communities. As a privately held company, we have the freedom and focus to do what is right—whatever it takes. Our tailor-made solutions create lasting results across the public and commercial sectors, and we are trailblazers in bringing neurodiversity to the enterprise. Job Summary We are looking for a motivated Data Analyst ready to take us to the next level! If you have SQL, Excel, Collibra and other data management tools and are looking for your next career move, apply now. Job Description We are looking for a Data Analyst This position will be full-time and Hybrid (Bangalore). What You’ll Do Conduct thorough data audits to identify any discrepancies or inconsistencies in data quality tool like Collibra. Collaborate with internal teams to understand data requirements and provide solutions to enhance data quality. Collaborate with Corporate Data Quality Teams. Develop and implement data quality standards and best practices. Analyze complex datasets to identify patterns, trends, and insights. Ensure data integrity and accuracy by performing regular data validation checks. Collaborate with stakeholders to understand their data needs and provide recommendations for data quality improvement. Participate in the design and implementation of data quality control processes. Communicate data quality issues and solutions effectively to both technical and non-technical stakeholders. Stay up-to-date with the latest industry trends and advancements in data quality practices. What You'll Need Bachelor's degree in Computer Science, Information Systems, or a related field. Proven experience in data analysis and quality assurance. Proficiency in SQL, Excel, and data management tools like SAP MDG, Collibra / Informatica. Strong attention to detail and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and collaborate effectively in a team environment. Strong organizational skills and ability to manage multiple priorities. Knowledge of data quality frameworks and methodologies. Physical Demands Sedentary work that involves sitting or remaining stationary most of the time with occasional need to move around the office to attend meetings, etc. Ability to conduct repetitive tasks on a computer, utilizing a mouse, keyboard, and monitor. Reasonable accommodation statement If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employment selection process, please direct your inquiries to application.accommodations@cai.io or (888) 824 – 8111.
Posted 1 week ago
2.0 - 4.0 years
3 - 7 Lacs
kachchh
Work from Office
Adani Hospitals is looking for Executive to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures Quality Executive MBA / MHA
Posted 1 week ago
3.0 - 6.0 years
3 - 6 Lacs
Hyderabad, Telangana, India
On-site
Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus
Posted 1 week ago
3.0 - 8.0 years
2 - 5 Lacs
Dombivli
Work from Office
Role & responsibilities 1) SOP Preparation 2) Daily/ Weekly/ Monthly/ Yearly Audit preparation 3) Internal Audit 4) ISO Audit Preparation 5) Daily MIS preparation 6) Monthly PPT submission and collection from department 7) All department documentation checking Preferred candidate profile
Posted 1 week ago
15.0 - 24.0 years
14 - 19 Lacs
Dahej
Work from Office
Leading the Quality Control Teamaccording to the norms of GMP (Good Manufacturing Practices) to ensure international quality standards and adherence to various regulatory requirements. Developing and reviewing cGMP compliance related documents like global procedures, methods, standards, specification, validation protocols, summary reports. Implementation of management system for Change control, CAPA, OOS, Risk analysis, deviation management system, incidents (Lab ware LIMS, eQMS,Track wise) and complaint management system. Actively participated in QTA between CMO and receiving/transferring site. Review and approval of APQR. Root cause analysis/ Failure investigation and corrective and preventive action planning Change control management system, CAPA, OOS, deviation management system, incidents Corrective and preventive action planning (CAPA) against the regulatory requirement. Implementation of CAPA effectiveness checks against the regulatory and existing quality system requirements. Deep knowledge in LIMS (Caliber/ LabWare management system and Thermo LIMS). GAP assessment of the quality system for process optimization and to assess the regulatory requirements against the gaps observed. Development and review of cGMP compliance related documents like global procedures, methods, standards, specification and validation protocols, summary reports. Immediate Joiners will be prefered. Kindly share resume on dipika.parmar@milanlabs.com
Posted 1 week ago
2.0 - 5.0 years
1 - 2 Lacs
Nagpur
Work from Office
Change Control & CAPA Management Initiation and documentation of Change Controls and CAPAs related to: SOP revisions Equipment qualification and modifications Deviations, self-inspections, and facility changes
Posted 1 week ago
5.0 - 10.0 years
4 - 9 Lacs
Bengaluru
Work from Office
REVIEWING EXECUTIVE BATCH PRODUCTION AND CONTROL RECORDS (BPCR) FOR ACCURACY AND COMPLIANCE WITH STANDARDS HANDLING, MONITORING, AND CLOSING OF CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) AND CONDUCTING EFFECTIVENESS CHECKS. AUDIT FACED USFDA AUDIT ANVISA AUDIT EU AUDIT DIFFERENT CUSTOMER AUDIT PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal
Posted 1 week ago
5.0 - 10.0 years
3 - 4 Lacs
Nuzvid
Work from Office
Role & Responsibilities: Physically verify raw materials and packaging per COA and MRN documentation Conduct routine checks on FG and SFG for pH, moisture, content, density Supervise personnel hygiene and ensure compliance with safety protocols Maintain calibration records for lab instruments Conduct pest inspections and ensure hygienic conditions Support R&D trials for quality improvements in FMCG products Perform shelf-life tracking and stock audits Ensure FoSTaC certification and food handler medical checks Follow up on market complaints and escalate quality issues Verify new packaging designs for compliance and legibility Maintain BOMs with Accounting for alignment with production and finance Lead GMP, HACCP, and FSSAI audit readiness efforts Coordinate fire safety drills, hygiene inspections, and corrective action Preferred Candidate Profile: 5 -10 years in FMCG, food production, or confectionery Proficient in HACCP, FSSAI guidelines, and FoSTaC Strong recordkeeping and documentation mindset Proficient in Telugu, Hindi. Experience in managing audits and lab instruments
Posted 1 week ago
3.0 - 5.0 years
2 - 4 Lacs
Vasai, Virar
Work from Office
Job Summary: We are looking for a detail-oriented and proactive Quality Control Engineer to join our team. The candidate will be responsible for Incoming Quality Control (IQC), In-Process Quality Control (IPQC), Vendor Quality Control (VQC), and documentation to ensure adherence to our product quality standards and specifications. Key Roles & Responsibilities: 1. Incoming Quality Control (IQC): Inspect incoming components such as castings, field coils, armatures, gears, etc., using standard checklists. Verify materials against technical drawings, specifications, and test parameters. Maintain IQC reports, rejection records, and vendor performance data. Communicate with purchase team and vendors on quality deviations. Conduct Pre-Dispatch Inspection (PDI) at vendor sites. Apply metallurgical knowledge during inspection of material and components. 2. In-Process Quality Control (IPQC): Conduct stage-wise inspections for sub-assemblies like gear housings, motor assembly, cover plates, etc. Monitor process parameters, dimensions, and workmanship using checklists. Ensure First Piece Approval (FPA) is done as per SOP. Escalate any non-conformities and halt production if necessary to ensure quality compliance. 3. Vendor Quality Control (VQC): Visit vendor facilities for pre-dispatch inspections and quality checks as required. Coordinate with vendors for continuous quality improvement. 4. Documentation & Reporting: Maintain daily inspection reports, rejection logs, control charts. Generate Material Deviation Reports (MDR), CAPA (Corrective and Preventive Action) reports, and RCA (Root Cause Analysis). Ensure traceability through serial number-wise component records. 5. Calibration & Equipment Monitoring: Ensure timely calibration of all measuring instruments and tools. Maintain accurate calibration records and ensure measurement reliability. Key Skills Required: Strong understanding of mechanical and electrical drawings, GD&T. Proficiency in inspection tools: Vernier, Micrometer, Multimeter, Bore Gauge, APG, Hardness Tester, etc. Familiarity with quality systems and tools: CAPA, RCA, 7 QC tools. Working knowledge of SAP and MS Office (Excel, Word). Effective communication and coordination with cross-functional teams (R&D, Production, Dispatch, Vendors). Basic knowledge of electrical testing and troubleshooting. Contact or Email for more details Call : V-mar HR 7666523051 Email : hrd@vmax.net.in Web: www.vmax.net.in
Posted 1 week ago
20.0 - 30.0 years
40 - 50 Lacs
Pune
Work from Office
Summary of the Role: The Quality Head will be responsible for overseeing all aspects of quality assurance and control for all the plants manufacturing die castings, machining & Auto components etc. This role will ensure the companys products meet industry standards and customer specifications, drive continuous improvement in manufacturing processes, and manage quality teams to achieve operational excellence. The Quality Head will work closely with the engineering, production, and operations teams to monitor and improve the quality of die-cast products , Auto components products and ensure compliance. Responsibilities: Quality Management System (QMS), Process Control & Improvement, Root Cause Analysis & Corrective Actions, Team Leadership & Training, Supplier Quality Management, Customer & Regulatory Compliance, Data Analysis & Reporting Required Skills: Full Time BE/B Tech - Metallurgy /Mechanical Engineering with 20 years of experience in quality assurance or quality management in a manufacturing environment, with at least 5 years in a leadership role. Extensive experience in the die casting industry, with in-depth knowledge of die casting processes (high pressure, low pressure, die casting alloys, etc.) & CNC Machining Process Proven track record in implementing and maintaining Quality Management Systems (QMS), as well as in process control and improvement techniques. Certification in Quality Management (e.g., Six Sigma Black Belt, ISO 9001 Lead Auditor) Knowledge of automotive quality standards (IATF) Strong understanding of die casting processes, CNC Machining and quality control methods, including dimensional inspection, mechanical testing, and non-destructive testing (NDT). Proficiency in quality tools and techniques (e.g., SPC, FMEA, 8D, root cause analysis, and control charts). Kindly share your resume on sv12@svmanagement.com or Contact on 0731 4228512
Posted 1 week ago
2.0 - 7.0 years
5 - 5 Lacs
Kolkata, Bengaluru
Work from Office
Quality Analyst//Sr Quality Evaluator Leading BPO in Bangalore & Kolkata International Voice Process Must be working as Quality Analyst for minimum 1 Year on papers Must be Excellent in 7QC Tools CTC UPTO 5.5LPA based on Last CTC Cabs in Odd Hours Looking for Candidates with Max 1Month of Notice Period PLEASE NOTE- THIS IS NOT TESTING PROFILE Role and Key Responsibilities: • Conduct Quality audits on Email, Chat & Calls and share feedback with agents. • Conduct compliance and Quality checks and ensure timely reporting. • Drive continuous improvement - make recommendations and drive improvement. • Data analysis and creation of designated reports/ presentations. • Strengthen Quality management processes/ framework to improve quality delivery. • Ensure data management for all deliverables and be accessible without any delay. • Client Escalation Management. • Participate in internal & external calibrations to ensure consistent scoring & feedback delivery approach. Key skills & knowledge: • Good verbal and written communication skills. • Hands on experience in MS Excel, Power Point presentations and Reporting knowledge. • Flexible to work in Shifts 24/7 Environment. • Ability to work under pressure and in strict timelines. • Exposure to online retail/ recovery will be an added advantage. Interested Candidates can call at 8467054123 or mail their cv at simmi@hiresquad.in
Posted 1 week ago
5.0 - 8.0 years
5 - 8 Lacs
Bengaluru
Work from Office
Team Leader Quality - Private Label FMCG (Non-Food: Home Care, Personal Care, Baby Care Products) Location: Bangalore Job Summary: Team leader Quality Private Label FMCG (Non-Food) will be responsible for ensuring the highest quality standards in the development, production, and delivery of Home Care, Personal Care, and Baby Care products. The role involves collaborating with cross-functional teams, managing supplier quality, and adhering to regulatory compliance to ensure customer satisfaction and brand reputation. Key Responsibilities: Define and implement quality standards, specifications, and guidelines for Home Care, Personal Care, and Baby Care product categories. Work closely with 3P Suppliers for R&D and product development to ensure products meet safety, performance, and quality benchmarks. Conduct product evaluations, sensory testing, and performance assessments during development phases. Ensure the products comply with regulatory standards- BIS,FDA,ISO, Ayush Conduct comprehensive audits of Home Care, Personal Care, and Baby Care product Suppliers to ensure compliance with quality standards and regulatory requirements. Ensure on boarding of New FMCG suppliers with adherence to quality and regulatory criteria. Analyze quality trends and implement continuous improvement initiatives across manufacturing and supply chain processes. Identify root causes for quality issues and drive corrective and preventive actions. Provide training and support to new suppliers to help them understand and comply with company standards. Responsible for handling end-to-end quality operations in the retail supply chain. Travel to multiple 3rd party supplier locations within the city and out of the city for Quality inspections and solving the issues. Framing of Specifications and SOPs for Home Care, Personal Care, and Baby Care Products Should have good command on leading the FMCG Nonfoods Project from development to Implementation. Strong Technical Knowledge on Drug &Cosmetic, Ayush license, LM , PCB & Labeling Guidelines. Develops and implements Nonfood regulatory and quality strategic plan for Private label brands in concert with corporate strategic plan. Address and resolve customer complaints related to product quality in a timely and effective manner. Use customer feedback to drive product and process improvements. Develop supplier QA team continuously through training, knowledge sharing and follow up. Working and interacting daily with the 3 rd Party Suppliers and corporate QA Team on projects related to Quality and safety efficiencies. Guidance needs to be provided from time to time for the Supplier Quality Team. Key Skills: Ability to develop & lead the project Individually. Should have strong experience in managing stakeholders and understanding of the strategic sourcing process. Able to utilize and critically evaluate data from a variety of sources to identify root cause and lead teams towards resolution. Proven experience in NonFood Categories like Home care, Cosmetics, paper & disposables, party needs, puja articles, general merchandise etc. Process oriented with excellent communication and problem-solving skills. Strong communication skills verbal and written, ability to communicate effectively to varied audiences Self-motivated, able to perform role with minimal supervision Able to manage multiple priorities in a dynamic environment Ability to work in a team environment to consistently achieve results & achievement. Strong organizational skills Demonstrates a positive can-do excellent teamwork attitude with strong communication/ information sharing skills A self-starter capable of designing and implementing services/processes Team player who can collaborate across multiple functional areas Qualifications: Bachelors/Masters degree in Chemistry, Cosmetology Chemical Engineering Minimum 6 years in quality assurance/quality control, preferably in FMCG (Non-Food) Home Care, Personal Care, or Baby Care products. Familiarity with chemical formulations, product testing, and regulatory frameworks. Proficiency in quality management tools and techniques (e.g., FMEA, SPC, CAPA). Should have Good Knowledge on Data analysis & Excel, Word, PPT. How to Apply Interested Candidates please share your resumes at - sandhya.tiwari1_ch@external.swiggy.in
Posted 1 week ago
3.0 - 7.0 years
7 - 11 Lacs
Thiruvallur
Work from Office
Career Area: Supply Chain and Logistics : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role Definition Dynamic person with excellent attention to in-depth details and exceptional analytical skills to analyse the data efficiently through effective coordination with key stake holders having collaborative attitude and deliver the best together in Bill of material creation & accuracy level maintenance, Engineering change implementation and Excess/Obsolete stock scrap clearance. Responsibilities Ensure MBOM & MRP Parameters Accuracy with frequent validation & actions required. Quality Material Master creation for NPI Programs with variant configuration In accordance to change control procedures implement Engineering changes Lead NPI parts & EC Parts coordination to ensure product changes are implemented on time. Eliminate Excess and Obsolete Stock Effective Scrap reduction through Request to Scrap Surplus Material process. Strong Understanding of SAP MM Degree Requirement Degree or equivalent experience desired Skill Descriptors Analytical Thinking Knowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. Level Working Knowledge Approaches a situation or problem by defining the problem or issue and determining its significance. Makes a systematic comparison of two or more alternative solutions. Uses flow charts, Pareto charts, fish diagrams, etc. to disclose meaningful data patterns. Identifies the major forces, events and people impacting and impacted by the situation at hand. Uses logic and intuition to make inferences about the meaning of the data and arrive at conclusions. Assists in the development of process flows to track lead time by activity. Rely on independent decision making to complete job tasks on identified areas. Project Management Knowledge of effective project management strategies and tactics; ability to plan, organize, monitor, and control projects, ensuring efficient utilization of technical and administrative resources to achieve project objectives. Level Working Knowledge Provides input for Gantt or PERT charts or their equivalent to track project progress and status. Under guidance, plans and estimates simple projects. Assists in detailed project plans including cost, schedule, and resource requirements. Obtains information from stakeholders during the planning stage of a project. Produces standard project status report. Problem Solving Knowledge of approaches, tools, techniques for recognizing, anticipating, and resolving organizational, operational or process problems; ability to apply knowledge of problem solving appropriately to diverse situations. Level Working Knowledge Identifies and documents specific problems and resolution alternatives. Examines a specific problem and understands the perspective of each involved stakeholder. Develops alternative techniques for assessing accuracy and relevance of information. Helps to analyse risks and benefits of alternative approaches and obtain decision on resolution. Uses fact-finding techniques and diagnostic tools to identify problem Collaborative Working Ability to work in synergy as a team seamlessly leverage one anothers strengths, embrace diverse viewpoints, brainstorm collectively to complete projects, develop solutions, and achieve shared/mutual objectives creating additional value to the organisation. Level Working Knowledge Enhances problem solving by developing a combination of various solutions and result-oriented approaches brainstorming together with in the team and with cross functional team. Promotes face-to-face interaction and open communication with other team members for better teamwork. Involves all project members in collaborating extensively Material Master (MM) Creation & MBOM Accuracy Knowledge of SAP MM for managing the material-related aspects of BOM, MRP Parameters, engineering changes and Variant Configuration ensuring efficient and accurate implementation of Master BOM and Engineering Change. Level Working Knowledge Obtains key information from necessary stakeholders in the right time for NPI Program and ensure quality Material Master (MM) creation with MRP Parameter & Variant Configuration update. Frequent validation of MBOM to maintain accuracy. MRP Parameters monitoring & maintenance. Lead production meeting regarding the introduction of NPI parts and attend NPI Meetings to ensure product changes are coordinated. Ensure to meet deadlines with flawless launch of NPI parts. Monitor and eliminate Excess and Obsolete Stock through RSSM Process wherever applicable. May enter drawing change information and new release information into EDS. Follows established procedures, documentation requirements and approval level requests wherever applicable. Engineering Change Coordination: Knowledge of SAP MM and engineering change best practices and ability to use methods for identifying, evaluating, introducing and implementing more efficient approaches to perform effective implementation of Engineering changes on time. Level Working Knowledge Analyse Engineering packages to determine priorities and establish dates for releases or Engineering changes. Ensure parts availability for Purchasing and Material Planning procurement for engineering changes. Coordinate required rework or material scrap resulting from new releases or Engineering changes. Ensure to meet deadlines with flawless launch of Engineering Change parts. Follows established procedures, documentation requirements and approval level requests wherever applicable. Helps evaluate what factors should be addressed in the change program and suggests ways to reduce deviations and keep improving the processes continuously. Lead Engineering change control meeting with cross functional teams to ensure EC product changes are coordinated. This position requires the candidate to work a 5-day-a-week schedule in the office. Relocation is available for this position. Posting Dates: June 12, 2025 - June 24, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community.
Posted 1 week ago
6.0 - 11.0 years
9 - 13 Lacs
Aurangabad
Work from Office
Career Area: Manufacturing : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role DefinitionWork as a quality manager and lead the quality team for diesel engine and genset assembly & test function. Performs advanced inspection and audits to track, analyze, and report on materials, processes, and products to ensure conformance to company's quality standards.ResponsibilitiesManage the Dily quality issues on the engine assembly line. Guild team to analyse the issues and provide the RCCA. Maintain the best practices and discipline on the line and make sure the quality of the product is as per standard. Conducting measurement systems analysis; gathering, analyzing, and communicating non-conformance data. Analysing non-conformance data and maintaining quality system documentation. Should use the statistical analysis tools to analysis the problem. Participating in and offering technical support to internal and external ISO 9001 audits; following up response of corrective action from audit. Interacting with manufacturing other cross functional team members to determine root cause of quality issues and ensure that corrective and preventive action is implemented.Degree RequirementDegree or equivalent experience desiredSkill DescriptorsQuality ManagementKnowledge of quality management methods, tools, and techniques and ability to create and support an environment that meets the quality goals of the organization.Level Working KnowledgeUtilizes quality indicators relevant to own unit or function. Adheres to organizational quality management processes and practices. Applies key aspects of continuous improvement processes and evaluates impact on quality. Uses quality evaluation tools and techniques such as walkthroughs and inspections. Works with quality assurance methods, tools and techniques.Accuracy and Attention to DetailUnderstanding the necessity and value of accuracy; ability to complete tasks with high levels of precision.Level Working KnowledgeAccurately gauges the impact and cost of errors, omissions, and oversights. Utilizes specific approaches and tools for checking and cross-checking outputs. Processes limited amounts of detailed information with good accuracy. Learns from mistakes and applies lessons learned. Develops and uses checklists to ensure that information goes out error-free.CollaboratingKnowledge of collaborative techniques; ability to work with a variety of individuals and groups in a constructive and collaborative manner.Level Basic UnderstandingDemonstrates a basic understanding of the concept of collaborative processes. Explains the concept of collaboration as applicable to organizations. Provides examples of how collaboration has helped achieve organizational goals. Contrasts collaborative with competitive operating styles in organizations.Flexibility and AdaptabilityKnowledge of successful approaches and techniques for dealing with change; ability to adapt to a changing environment and be comfortable with change.Level Working KnowledgeAdjusts to new or changing assignments, processes, and people. Demonstrates willingness to listen to other opinions. Provides examples of shifting from task to task. Identifies and considers alternative approaches to situations or problems. Accepts new or radical ideas with an open mind; avoids snap reactions.Problem SolvingKnowledge of approaches, tools, techniques for recognizing, anticipating, and resolving organizational, operational or process problems; ability to apply knowledge of problem solving appropriately to diverse situations.Level Basic UnderstandingExplains the value of a disciplined approach to problem solving. Describes problem reporting and escalation practices. Utilizes accepted procedures for problem analysis and resolution. Identifies key aspects of problem-solving techniques used in own area.Manufacturing Standards, Procedures and PoliciesKnowledge of organizational standards, procedures and policies in manufacturing activities; ability to plan, guide, and monitor manufacturing processes for compliance.Level Working KnowledgeContributes to the development and implementation of specific manufacturing procedures. Investigates the need to refer potential exceptions upward for review and approval. Explains the rationale for procedures and standards in own area of responsibility. Participates in the implementation of manufacturing standards and procedures to one's own function. Provides feedback for improvement of procedures.Root Cause Analysis (RCA)Knowledge of the concepts, principles and techniques of root cause analysis (RCA); ability to use a structured approach to identify the causes of undesirable consequences in a manufacturing environment and the changes needed to prevent recurrences.Level Working KnowledgeUtilizes RCA techniques, such as Flowchart, Fish-bone Diagram, etc., to investigate basic problems, determine the causes, and find resolutions. Locates factors that resulted in harmful outcomes of one or more past events. Pinpoints behaviors, actions, inaction, or conditions that need to be changed. Extrapolates lessons to be learned to promote the achievement of better consequences. Practices RCA as an iterative process. Posting Dates: June 16, 2025 - June 24, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community.
Posted 1 week ago
3.0 - 5.0 years
3 - 7 Lacs
Coimbatore
Work from Office
This role involves the development and application of engineering practice and knowledge in defining, configuring and deploying industrial digital technologies (including but not limited to PLM and MES) for managing continuity of information across the engineering enterprise, including design, industrialization, manufacturing and supply chain, and for managing the manufacturing data. - Grade Specific Focus on Digital Continuity and Manufacturing. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight forward situations and generates solutions. Contributes in teamwork and interacts with customers.
Posted 1 week ago
2.0 - 4.0 years
2 - 5 Lacs
Akola
Work from Office
Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience
Posted 1 week ago
4.0 - 8.0 years
4 - 5 Lacs
Faridabad
Work from Office
Supplier Quality, Rubber Industry APQP, POKA-YOKE, Audits, MIS, Customer handle, English strong, Quality reports, ppe's, fpa, quality control, vendor quality, sqa,
Posted 1 week ago
7.0 - 12.0 years
7 - 12 Lacs
Bengaluru, Karnataka, India
On-site
Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.
Posted 1 week ago
1.0 - 3.0 years
3 - 5 Lacs
Navi Mumbai
Work from Office
Role & responsibilities Inspection - release/rejection of incoming material against approved specification. Rejection of material non conformance review, reporting in IMSxpress. Updation of critical incoming material list (incoming material specification) based. Allocation of catalogue number to finished products depending on customization/changes in product. Control of documents (QSP, SOP, formats, MFR, MQR) issuance, retrival, archival and updation in IMSxpress. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Daily IPQA of production and BMF as per the approved protocols and procedures and subsequent reporting. Issuance and handling of change control, non conformity, CAPA in IMSxpress Issuance and handling of Deviations Issuance and maintenance of BMR Handling, Recording and compilation of customer complaints Updation and maintenance of departmental risk register. Participating in product Validation. Review of packing order, checking of labels and Shipments to customers. Participating in Internal/external audit as per audit agenda and responsibility allotted. Preferred candidate profile Should have a Bachelors or Master's degree in pharmacy/biotechnology/Biochemistry or other relevant scientific discipline with 2/3 years experience in Quality Assurance. Knowledge of GMP standards, SOPs and quality management systems • Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards • Data collection and management • Customer service orientation • Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers • Strong and confident negotiator with the ability to negotiate at all levels • Excellent communication, interpersonal and influencing skills • Results orientated with ability to plan and deliver against deadlines • Ability to add value, reduce costs and make improvements • Computer literate, especially Excel skills
Posted 1 week ago
2.0 - 7.0 years
1 - 2 Lacs
Coimbatore
Work from Office
EXECUTIVE-SALES PPC/-/1306251 Marketing Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Marketing Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Market and Competitive Analysis Minimum Qualification Any Graduate BSc MBA CERTIFICATION No data available Working Language Tamil English About The Role Candidate taken for the replacement of Mr.N.Sabariyar who is looking in market cirlce-COI02 of Cbe branch.Candiate should be minimum 2-Years experience in marketing and having good knowledge in system.
Posted 1 week ago
0.0 - 1.0 years
0 - 1 Lacs
Mathavaram
Work from Office
Trainee - chemist PPC/T-C/1299164 Warehouse - Quality Madhavaram Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 1 - 1 years ShareApply Basic Section No. Of Openings 2 Designation Grade Executive M10 Freshers/Experience Freshers Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Warehouse - Quality Country India State Tamil Nadu Region Madhavaram Branch Madhavaram Skills Skill Quality Assurance Minimum Qualification BSc CERTIFICATION No data available Working Language English Hindi About The Role To Sample and testing the incoming Raw material, finished goods & Packing material. To inspect in process batch and to test for batch release. To inspect product vessels and provide clearance for production. To develop testing SOP and test methods. To coordinate during external and internal audi ti ng.
Posted 1 week ago
3.0 - 8.0 years
8 - 14 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A
Posted 1 week ago
4.0 - 9.0 years
4 - 9 Lacs
Hosur, Hubli, Bengaluru
Work from Office
Engr, Asst Mgr Q.A-in-house quality standards, QAD goals / target, Ensure periodic reporting Q.A Performance, CMM, CAPA, PPAP,FMEA, ISO 9001/14001/45001,5S, Customer complaints handling & effective problem-solving and global 8D, failure analysis
Posted 1 week ago
3.0 - 5.0 years
3 - 7 Lacs
Dahanu
Work from Office
Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists
Posted 1 week ago
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