1381 Qms Jobs - Page 48

• Responsible for analytical documents review, filing after approval for: • Batch Analysis • Method Validation and Method Transfers • OOS / OOT Investigations • Stability Protocols, Reports, Data • Certification of standards • Review of Specifications and Test Methods • Review of Calibration and Qualifications of Analytical Instruments • Audit trail review • Should understand all analytical instruments like HPLC, GC, Spectrophotometers, Other analytical instruments • Understanding of good laboratory practices in Quality control and Analytical Development and Validation • Understand 21CFR Part 11 requirements, Audit trail reviews, GMP requirements, ICH guidelines on Specifications, Method validations.

• Responsible for QA activities & review of documents in the area of: • Quality Management Systems, Incidents & Investigations, IPQA, Internal Audits • Document control • Batch review and release, Dispatch • Validations, Qualifications • Product Quality review • Logging, Investigating and closing Quality events (Deviations, OOS&OOTs, Complaints), Participate in Investigations • Logging, Tracking, Closing Changes, CAPAs • IPQA and Internal Audits • Document Management – Issuance, Retrieval, Archival • Review of Quality System documents such as -Batch records, Validation reports, Qualification reports, calibration reports • Review Dispatches and documentation • Review Vendor Qualification, • Coordinate Training Management, Samples dispatch • Sampling of intermediate/ APIs

• Responsible for Operations of Quality control • Implementation of all Quality control procedures, Maintaining and Upgrading systems and processs in Quality control to meet most stringent regulatory requirements (GMP / GLP) • Handling all Regulatory audits, Client Audits, Internal Audits in QC • Planning and coordination for analysis and release of Input, Inprocess, Final products in time • Planning and management of resources for Quality control – Instruments, Chemicals and consumables, Manpower. • Providing all documentation and other necessary support for Regulatory for product registrations and life cycle management from Quality control

Collect and analyze data from various sources, including surveys, market reports, and online databases Interprete data, draw conclusions and make recommendations based on findings Develop and maintain data collection and reporting systems Communicate findings and recommendations clearly and effectively to both technical and non-technical stakeholders Work with cross-functional teams, such as sales, marketing, and product development, to support their decision-making needs Prepare reports, charts, and presentations to present research findings to senior management Excellent written and verbal communication skills Attention to detail and accuracyFamiliarity with research methodologies and market research techniques

Collect and analyze data from various sources, including surveys, market reports, and online databases Interprete data, draw conclusions and make recommendations based on findings Develop and maintain data collection and reporting systems Communicate findings and recommendations clearly and effectively to both technical and non-technical stakeholders Work with cross-functional teams, such as sales, marketing, and product development, to support their decision-making needs Prepare reports, charts, and presentations to present research findings to senior management Excellent written and verbal communication skills Attention to detail and accuracyFamiliarity with research methodologies and market research techniques

Collect and analyze data from various sources, including surveys, market reports, and online databases Interprete data, draw conclusions and make recommendations based on findings Develop and maintain data collection and reporting systems Communicate findings and recommendations clearly and effectively to both technical and non-technical stakeholders Work with cross-functional teams, such as sales, marketing, and product development, to support their decision-making needs Prepare reports, charts, and presentations to present research findings to senior management Excellent written and verbal communication skills Attention to detail and accuracyFamiliarity with research methodologies and market research techniques

Role & responsibilities in Total in in in charge to take as senior Quality Manager/Assurance and handle the entire department Preferred candidate profile Perks and benefits

Navi Mumbai Role Responsibilities: Candidate Skillset: QMS, MR, QMS coordinator, ISO 9001, 27001. Candidate must have experienced/attended the recertification audits, and Surveillance audits. Candidate should be from an IT service industry. Provide training and support to staff on QMS and ISMS processes. Lead and mentor junior team members. Proven leadership and team management experience. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Qualifications: Bachelor s degree in IT/Computer Science/ Electrical / Electronic or a related field. Professional certifications such as ISO 9001, ISO 27001 Certification.

Experience in working on plastic component, die casting and sheet metal Should be able to design and develop with design calculations techniques like Geometric dimensioning and tolerancing Should have knowledge on NPD cycle and quality management system Should have knowledge on APQP, PPAP documents Design and development of plastic modelling Support all phases of development from requirements to deployment Interface with internal development teams Demonstrate excellent communication Skills Verbal & Written Demonstrate good Team Player skills Experience 3 5 years

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications. 1. Applies scientific methods to analyse and solve software engineering problems. 2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance. 3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers. 4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities. 5. The software engineer collaborates and acts as team player with other software engineers and stakeholders. Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders. Job Description - Grade Specific Has very deep understanding of software development principles and technical proficiency. Masters all phases of the software development lifecycle and drives innovation and industrialization. Works on highly complex tasks and problems and drives technical decisions at a high level. Clear evidence of thought leadership in the market. Builds, educates and integrates effective teams. Focuses on developing long term partnerships with clients. Takes full responsibility for outcomes. Has strong understanding of contractual, financial and technical considerations. Exhibits strong commercial management skills. Takes a high degree of responsibility and ownership of people issues. Skills (competencies) Verbal Communication

Job Description Roles and Responsibilities: Demonstrated expertise in Process Quality and Product Validation. Proficiency in PPAP documentation, Line/Process Audit, and Control Plan. Strong knowledge and hands-on experience with PLM Applications. Must have experience with ESD 20:20 and IATF standards. Technical knowledge of PFMEA, SPC, MSA, Poka-Yoke, Kaizen, and 7QC tools. Should have knowledge of Electronic and Mechanical assemblies Educational qualifications with a consistent academic record of 60% or above throughout. Excellent communication skills, with the ability to convey technical information effectively. Preferred Candidate Profile: Diploma/B.Tech (Electrical or E&E) graduate with 2 to 6 years of experience in the Electronic Manufacturing Industry, particularly in SMT and assembly in QA. Preferably from the Electrical/Electronic Manufacturing Industry. Regards , Vasanth Kumar M 90477 44528 (What's app) vasanthkumar.m@haarvard.com

1. Setting up and maintaining controls and documentation procedures (QMS). 2. Reduce warranty defects 3. Conduct Quality Systems audits at various process of plant 4. Reporting monthly performance report of QA function 5. Contribute to continual improvement activities 6. Conduct product audit for improving product quality. 7. Final vehicle inspection & defects updation 8. FTR processing & control of records 9. Implement Product & Process changes (ECN) 10. Conduct part & process parameter audit & get corrective actions for the non-conformance identified. 11. Identification & Implementation of SIT/CFT projects related to policy & MPCP 12. Handling end-to-end quality along with team Work Experience 1. 10 years in automobile / auto parts manufacturing company. Preference will be given to candidates from direct competition

1. >6 years experience in Quality assurance 2. Adequate exposure of Internal audits 3. Adequate exposure in external audits NABL, CAP etc 4. Will be on travelling profile 5. Preparing the assigned labs for NABL audits , conducting internal audits 6. Monitoring the assigned labs for Quality assurance, IQC , EQAS, IQC outliers, CV% etc 7. Preparing SOPs , QSPs 8. Should have faced 10+ NABL Audit 9. Should have good team leading skills 10. Should have completed ISO 15189 2022 course Interested candidates can share resume to sanjay.behera@thyrocare.com or whatsapp to 8928285213

Requirements Diploma/Degree in Mechanical, Instrumentation, Production Engineering, or equivalent. 1-2 years of experience in similar roles and industry Strong communication, interpersonal, and team management skills. Proficiency in data analysis with attention to detail and problem-solving abilities. Excellent understanding of QMS standards (e.g., ISO 9001), documentation, and basic computer skills. Understanding of engineering drawings, measurement tools, and time management. Roles and Responsibilities Implement, maintain, and continually improve the organization s QMS to ensure compliance with standards such as ISO 9001. Plan and conduct internal audits, process validations, and quality assessments to ensure adherence to ISO standards (e.g., ISO 9001, AS9100) Ensure effective control and management of quality documentation and records. Conduct quality training and collaborate with teams to align and integrate quality objectives with business goals. Monitor QMS performance, report to management, and update quality policies and procedures as needed. Preferences Residing in or near Vasai.

Testing Engineer - Mumbai Job brief:- We are looking for a Test Engineer who will thoroughly inspect our products/features/websites before they re launched. As a Test Engineer in our company, you will work closely with the product/business tech teams to understand why we re building a product and what the specific requirements are. Then, you will run tests throughout dev and staging environments to identify potential defects and also recommend improvements to the product team. Ultimately, you ll ensure our final products meet our quality standards. Responsibilities:- Gather product requirements (e.g. CRM updates, Website updates, Integration requirements) Develop test environments and test cases for all changes/enhancements as well as regression tests Analyze test results, detect issues and track root causes Suggest fixes and improvements Document technical issues and solutions Build automated testing systems for regular checks Ensure all features/products meet our quality standards Requirements Previous experience as a Test Engineer or similar role Familiarity with various testing techniques Hands-on experience with any Quality Management Systems (QMS) Great troubleshooting skills Analytical mindset

Role & responsibilities Preparation and review of process documents (PCS, MFR, BMR,TTD), SOPs, protocols, investigation reports related documents for upstream activity. Responsible for LMS activities as a department training coordinator (DTC) for upstream. QMS handlings i.e. initiation, follow-ups and closure of change control, deviation, CAPA related to Bulk Manufacturing. Have clear understanding of Manufacturing and microbial commercialization activities of a biologics product & related documentation. Having wide experience in Microbial fermentation handling process Techniques (Handling of Bioreactors, Cell separation by Continuous Centrifuges, homogenizers). Extensive experience in trouble shooting process related issues during manufacturing. Tracking of inventory of buffers and consumables used in manufacturing through MDO/ Prosol tools/SAP related activities for commercial batches. Sound knowledge on Track wise, EDMS, EBMR request. To understand and follow the safety practices and usage of PPEs in Bulk Manufacturing facility and during process. Execution of Scale up of Development batches/ other assigned tasks in Bulk manufacturing facility as per the assigned in shift hours. Ensure Facility monitoring, readiness & maintenance of BM facility. Coordination with engineering department on tracking and completion of preventive maintenance of Upstream Process Equipment and instruments. Following good documentation practices such as online documentation like BMR, equipment log books, record sheets etc. in upstream process. Following up with Vendors on equipment and instrument related to upstream process. Support, follow and fulfill for any additional work activities /other job responsibilities/tasks assigning by reporting manager. Preferred candidate profile Candidates working in the field of Biotechnology will be Preferred Perks and benefits As per Industry Norms

Aster Medcity is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey. Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Followings will be the Core Job Responsibilities of the position holder: Ensure the Compliance to laid standards of the current Good Manufacturing Practices. Carrying Qualification of Production equipment and compliance to specifications and validated methods Preparation of Standard Operating Procedures for equipment. Implementation of Quality Management System as per cGMP and international requirement at all levels of Manufacturing. Training and evaluation of the Technicians for their qualifications of specific task to operate specific equipment. Coordination with production Planning department and QA for work order and Batch Record document. To exercise effective control over the environmental conditions in Manufacturing and other related activities, which may adversely affect the product quality To co-ordinate for calibration / preventive maintenance for all production equipment and instruments with engineering / QA / QC outside agencies. Organizing the job responsibilities to the technicians as per daily plan. To exercise effective control over the process variable affecting the quality of the product. To fill and maintain the BPR/ BMR on line and to maintain /fill the formats and other related documents. To ensure maintenance of production Area and equipment in the state of cleanliness as per the SOPs at all points of time. Continuous monitoring and improving the production output on daily basis. In absence of the position holder, the sub-ordinate Executive / Manager working in the section or the authorized designee (as applicable) shall be responsible for day to day working.

Analysis of defective product input data from customer related to inbound/outbound information Previous manufacturing/repair history of product. Perform Post Good Receipt (PGR) Activities in SAP. Release, print Closure of Production/Service work order as per analysis PO information. Printing of labels as per DMR. Prepare the RMA packet. Manage Outbound deliveries as per weekly plans. Management information system (MIS) KRA: Quality performance- FPY- First Pass Yield o DEFOA -Defect on Arrival On time performance COTS - Delivered on time as confirmed/scheduled OTTP/R - Delivered On time to request Performance to standard hours- Efficiency - Standard hours for task/actual hours used Youre the right fit if: (4 x bullets max) 1. Experience- Requires a minimum of 4-6 years of related experience. 2. Skills- Inbound Outbound Logistics Knowledge of Quality Management system Flow of goods and material Planning Exposure to ERP (SAP) 3. Education- Diploma in any engineering 4. Anything else- Communication skills Collaboration with cross functional team members. Personal Professional opportunities for development within this role of production planner.

Roles and Responsibilities Conduct vendor audits, root cause analysis, and deviation management to ensure compliance with quality standards. Prepare SOPs for QMS implementation and maintain accurate records of market complaints, CAPAs, and change controls. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Ensure timely completion of tasks related to APQR (Advanced Product Quality Review) and participate in continuous improvement initiatives. Maintain a high level of accuracy in data entry, documentation, and reporting.

Quality Manual. * Preparation and Approval of Standard operating Procedures. * Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data. * To co-ordinate the Qualification / Validation of the Equipment, Systems and Process. * To ensure the issuance of required documents and samples for Drug and Regulatory Affairs. * To ensure the preparation, Issuance, Revision/Review and Retrieval of the documents. * To investigate the cause of any non conformance and its corrective / preventive action. * To ensure the Analytical method validation of cleaning process before conducting Cleaning validation. * Preparation of Cleaning Validation Master plan. * Preparation and Execution of Cleaning validation protocols. * Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation. * To conduct or organise revalidation activity at the defined frequency. * To control the inventory of control samples. Officer/ Sr. Officer (IPQA Tab/Cap) 2-5 years Over all IPQA activity (Tab/Cap) + Validation + Licensing work (FDA) Officer/ Sr. Officer (Liquid IPQA + Validation) 2-4 years Over all IPQA activity (Liquid) + Validation

Role & responsibilities Adopt best practices, policies, processes and procedures to deliver quality products and improve business performance. Prepare short term and long term quality improvement plan for MKU. Define annual business goals for quality function in the plant, set functional KRA/KPIs in alignment with the business goals. Prepare the annual Quality budget for all the plants (Malwan and Rooma) before the start of the financial year. Proactively assess quality risks a continuous basis and implement a system of continuous improvement throughout the organization. Assess adequacy of QMS when new projects and technology are introduced and recommend requirements for upgradation. Assess inhouse/3rd party testing of material quality, develop inhouse capability and get necessary accreditation of the laboratories. Explore opportunities of technology upgradation and new technology adoption Understand customer needs and requirements to develop effective quality control processes Lead and manage the quality function from incoming raw materials, in process quality to delivery of FGs and post-delivery support to ensure quality of the products. Review the QMS at defined frequency, report noncompliance to SOPs, WIs and closure of CAPA. Ensure internal and external audits are carried out as per plan, participate in closure meeting, review the noncompliance and action plan for improvement. Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies ( ISO 9001-2015, AS 9100 Rev. D, ISO 14001, ISO 45001, BA 9000-2016 and ISO 17065-2015.) Visit key suppliers to assess their quality system and submit recommendations to the procurement department. Review all customer complaints, repeated quality issues, lead root cause analysis of the failures and coordinate with all stakeholders for timely closure of the countermeasures. Review quality specifications of critical input materials, SFG and FG and monitor compliance and approve deviations as per SOP. Implement new quality processes and systems where appropriate. Participate in project planning, review risks related to quality and improve the processes and products to meet the customer needs. Review calibration schedule and maintenance plan for the lab equipment and ensure adherence to plan. Monitor KPIs for the quality function of the plants and review major deviation analysis and improvement plan. Assess Cost of Poor Quality (COPQ) and take up initiatives with other functions to reduce COPQ. Collaborate, negotiate and engage with key stakeholders to deliver quality products to customers. Report on Quality activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators. Coordinate with the Product Innovation team to ensure compliance to quality parameters for new product development Coach, mentor and develop direct reports and develop a quality culture of continuous improvement. Keep up to date with developments in new technologies/ production techniques by reading relevant journals, and attending seminars etc. Conduct training on QMS for HODs. Conduct goal cascading exercise to align KRA/KPIs of manufacturing team with business goal. Ensure KPI targets are set properly and goal deployment is completed as per timeline. Review half-yearly review and annual performance as per MKU policy. Proven leadership and management skills with the ability to optimize team performance and development. Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers. In depth understanding of quality control and quality assurance procedures. Knowledge and understanding on various QMS especially ISO 9001-2015, AS 9100 Rev. D, ISO 14001, ISO 45001, BA 9000-2016 and ISO 17065-2015. Excellent communication, interpersonal and influencing skills Excellent analytical and problem-solving abilities Preferred candidate profile Graduation in Engineering / M Sc. Leader Auditor Certification in ISO9001

Hi, We are having an opening for Manager- Quality Informatics in our IT department at Halol location. Job Summary : Quality Control GxP Systems - Chromatographic & Non chromatographic systems, Data backup, User management, system software trouble shoot (L1), Computer system validation, Regulatory & Customer audits and compliance, QMS related IT (like Change control, Deviation, Investigation) etc. Areas Of Responsibility : Perform in-house software validation, re-validation of computerized systems of QC Lab and Micro area. Initiate and prepare active user list for Laboratory systems & Perform periodic access right and security policy review for Laboratory systems. Implementation of security policies as per site and global procedure. Perform administration activities as per procedure for computerized systems and instruments. Preparation of data backup and restoration procedures. Execution of manual backup and restoration in lab applications as per procedure. Coordinate with Corporate QA IT and QA department for implementation of Global Procedure. Prepare the SOP/CSAP for Lab computerized systems. Updation of roles and privileges as per business owner requirements and to perform validation related activity. Support Infra-IT activities. Authorized to review/ Signoff the documents related to the Quality informatics systems. Knowledge of Empower, Chromeleon, LABX, ICDAS, Lab Solutions. To perform QMS related activity. Educational Qualification : Diploma IT, BE IT, Computer Science Experience : 12 + Years

Job Title ConX Systems – TCAM Software Manager Responsibilities Join our core R&D Automotive Engineering Team for our marquee Swedish Account- Polestar!Infosys is hiring core Automotive R&D professionals as part of a dedicated Offshore Delivery Center being setup for Sweden’s marquee EV brand ‘Polestar’ at our Electronics City, Bangalore Campus. This is an opportunity to be part of cutting edge automotive software projects, working with passionate global teams tackling real-world Automotive and next-generation Electric Mobility Challenges. If such an opportunity excites you, apply for the job opening below -Key Accountabilities and Responsibilities: Workstream – Software Manager for the TCAM Software stakeholder management (external function groups) and alignment Project Management skills – timing and issue reporting Work with the tier 1 to plan appropriately the software deliveries including the many software workstreams being integrated into the TCAM such as:TSP, RMS, RVDC, eCall, bCall Tier 1 management against the internal milestones (software inputs, software development, software testing and reporting) Creating and presenting timing plans to senior stakeholders about risk and opps of the software project plan for the TCAMWe're keen to talk to people with the following skills and experience: Masters or Bachelor of Science in Electrical Engineering or similar discipline More than 5 years of experience working within the automotive industry as a Component Owner or software project manager within the ConX domain. Project management tools (JIRA advanced roadmaps, smartsheets, MS project etc etc.) Experience in delivery in ConX End-to-End solution and products, including telematics or other complex software components. JIRA experience is desirable but not essential Fluent in EnglishIf you are passionate about cars and cutting edge technologies, committed to delivering high quality software and, someone with strong analytical and problem solving skills, then this is the right job for you! Technical and Professional Requirements: Work with the tier 1 to plan appropriately the software deliveries including the many software workstreams being integrated into the TCAM such as:TSP, RMS, RVDC, eCall, bCall More than 5 years of experience working within the automotive industry as a Component Owner or software project manager within the ConX domain. Project management tools (JIRA advanced roadmaps, smartsheets, MS project etc etc.) Experience in delivery in ConX End-to-End solution and products, including telematics or other complex software components. JIRA experience is desirable but not essential Fluent in English Preferred Skills: Domain->Automotive->Infotainment System Domain->Automotive->Automotive - Systems Domain->Automotive->Connected Car Domain->Automotive->Electric Vehicles (EVs) Educational Requirements Master Of Comp. Applications,Master Of Engineering,Master Of Science,Master Of Technology,Bachelor Of Comp. Applications,Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

Strong knowledge of FDA regulation, ISO 13485 and QMS principles Qualification : BSc / MSc / B.Pharm / M.Pharm No. of Vacancies : 1 Experience : 1-2 Years in Medical Devices / Pharmaceuticals or Surgical industy