This role supports Quality Management System (QMS) activities including tracking and reviewing CRFs, CAPAs, deviations, and SOPs across multiple sites Responsibilities include documentation control, data analysis, digital transition support, and coordination with site teams to ensure compliance with cGMP standards The position also involves audit support, workflow optimization, and cross-functional collaboration to drive timely closure of quality events B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Track and follow up on pending TrackWise CRFs and CAPAs. Perform effectiveness checks for closed CAPAs and CRFs. Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs). Monitor and track SOP periodic reviews across sites. Support SOP updates, including formatting checks and revision history verification. Facilitate the creation and routing of CRFs for SOP revisions. Assist in the transition from physical to electronic forms (Leucine project). Support the review of manufacturing documentation (e.g., shipping/receiving logs, PM records). Collaborate on defining and improving document workflows and review processes. Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed. Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance. Collaborate with site teams to resolve gaps identified during QMS event review and documentation. Engage with customers and site teams to ensure timely closure of critical QMS events. Coordinate site review activities and ensure workflow efficiency. Route documents through the ENSUR application or other platforms across Piramal plants. Participate in customer audits and regulatory inspections, supporting site teams as needed. Lead or contribute to additional assignments as directed by the Head of Department (HOD).

Role & responsibilities Greetings from Randstad India !! We are looking to fill a Asst Manager- Quality position at our client. MNC Company is known for designing furniture in commercial places. Below are the details about this role, Position Summary- Looking for an Asst. Manager Quality with 5 to 8 years of experience in managing Quality Management Systems (QMS) and EHS compliance. The role involves conducting internal and third-party audits, ensuring timely NCR closures, and managing ISO 9001, 14001 & 45001 documentation. Responsibilities include organizing MRM, employee training, and instrument calibration. Proficiency in audits, documentation, and MS Office is essential. Mechanical engineering qualification (D.M.E./B.E.) is required. below is the detailed job description. - Qualifications and Key Skills and for this role, DME/B.E./B. Tech in Mechanical. Experience in ISO 9001, ISO 45001 and ISO 14001, Knowledge of QMS, Health, safety and environmental system documentation Ensure quality management and EHS systems, conduct internal and third-party audits & its effective closure Prepare system requirements documentation and MRM reports Experience in handling audits, customer complaints, and root cause analysis Proficient in quality tools like 7 QC Tools, FMEA, CAPA, and SPC Preferred candidate profile Any Manufacturing company Preferred : Retail Manufacturing company

Key Responsibilities: Quality Testing & Inspection: Supervise and perform testing of pressure cookers and cookware for durability, performance, safety, and compliance. Ensure all test methods are aligned with national and international standards (e.g., ISO, BIS, ASTM). Monitor pressure retention, sealing integrity, material strength, non-stick coating performance, thermal efficiency, and ergonomic assessments. Documentation & Compliance: Maintain detailed records of test procedures, results, deviations, and corrective actions. Ensure products meet regulatory and safety compliance requirements for target markets (e.g., BIS certification in India). Prepare documentation for audits, certifications, and customer inspections. Lab Operations & Management: Manage day-to-day operations of the QC lab, including calibration and maintenance of test equipment. Develop, review, and update Standard Operating Procedures (SOPs) and quality manuals. Manage a team of lab technicians and quality inspectors, providing training and performance oversight. Continuous Improvement: Analyze test results to identify trends and recommend improvements in manufacturing processes or product design. Collaborate with R&D, production, and procurement teams to resolve quality issues and improve product robustness. Lead root cause analysis and implement corrective/preventive actions (CAPA). Supplier Quality: Coordinate with suppliers and vendors to ensure incoming materials meet specifications. Conduct supplier audits as necessary and support the development of SOPs for supplier quality standards.

Min 2 yr BPO Sr Quality Manager Exp from BPO Industry Manage BPO Quality Team Call Callibration, Audit, Score WFO- KOL/ Lucknow /BLR only- APPLY ONLY IF CAN RELOCATE - no position in Delhi/NCR , Hyderabad Required Candidate profile WFO- KOL/ Lucknow /BLR only- APPLY ONLY IF CAN RELOCATE -no position in Delhi/NCR and Hyderabad Call/whatsapp CV Sri 8851792136, Neha 8287267407

Support for Ultrasonic Immersion testing of Steel Raw material. material development and testing projects in the R& D-Material department Perform material testing and analysis for various materials ranging from steel, casting, nonferrous materials, rubber, plastics, seal materials, heat-treated, coated & plated parts, independently and make final conclusive test report with recommendation, using various metallographic and material testing instruments & Equipment. Discuss, explain and conclude independently, the tested report with concern test requestors and close each task. Maintain and archiving the testing reports Plan, Operate & Maintain all material testing equipment facility independently including required spares for the equipment, do advance planning for the consumables require to perform the testing, ensure uninterrupted operation including periodic calibration of related equipment and testing facilities. Maintain the quality management system, safety system and 5S in the working area as well as for the departmental function. Actively participate in All kind of Audit activities including ISA, IATF, Plant Audits, Customer Audits etc. Your Qualifications Diploma/ B.E., (Material science/ Metallurgy/ Mechanical) 02-04 years of working experience in the field of material and metallurgical testing specifically Ultrasonic testing. Level 2 certification in UT testing will be an added advantage. Hands on experience and Knowledge in metallurgical and microstructure analysis techniques. Hands on experience and knowledge in Mechanical testing of raw material. Good communication and interpersonal skill. Basic knowledge of steel raw material and heat-treatment Knowledge of Quality management system like IATF, ISO etc. As a global company with employees around the world, it is important to us that we treat each other with respect and value all ideas and perspectives. By appreciating our differences, we inspire creativity and drive innovation. In this way, we contribute to sustainable value creation for our stakeholders and society as a whole. Together, we advance how the world moves. Exciting assignments and outstanding development opportunities await you because we impact the future with innovation. We look forward to your application. www.schaeffler.com/careers

A Day in the Life In this role, this role will partner with Quality System team members to generate, analyze, communicate, and follow up with stakeholders to actions related to standard reports for the following QMS processes: -Periodic Review of QMS procedures -Training coming due and/or overdue notifications -Quality Data Analysis (QDA) In addition, this role will assist in the retrieval, review, and archival of Allograft Tissue Tracing Records. Responsibilities may include the following and other duties may be assigned: Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office across the following CST QMS entities: o Boxborough o Caesarea o Fort Worth CSF o Fort Worth MPSS o Lafayette o Memphis Pyramid o Memphis SGT Generates and analyzes standard reports (e.g., Periodic Review, Training and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs Communicates coming due and/or overdue notifications for Training and Periodic Reviews to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to Agile MAP with regards to Document and Process Owners Coordinates with internal stakeholders to implement corrections to Cornerstone with regards to removal of unnecessary trainings Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred 3+ years quality assurance experience in medical or pharmaceutical industry Familiarity with medical device Quality Management System requirements (e.g., US 21 CFR Part 820, ISO 13485:2016, Regulation (EU) 2017/745) Experience running data queries and reports in software applications Strong verbal and written communication skills and ability to work in a team oriented environment Agile PLM knowledge/experience Ability to work independently once trained Ability to be proactive and lead initiatives Ability to multitask. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Pharmacy Work Experience 5 to 8 years

As a Quality Engineer, you ensure high quality of software solutions in collaboration with the whole development team. Your focus lies on effective testing, quality in automation, programming and deploying software. Automation of test activities plays an important part in your role. You understand and use the required tooling to support this. - Grade Specific You have >3 years experience as Quality Assurance and Test Engineer. You have respect and influence on customers and colleagues. You have experience with coaching and setting up new teams. You have several years of experience with various clients.

Hi All, We are hiring for Lead Auditor profile for Chennai location for various domain. JOB TITLE : Auditor / Lead Auditor LOCATION : Chennai QUALIFICATION : Graduate (Degree/Diploma) in Engineering (e.g. Chemical, Civil, Automobile, etc), Technology (e.g. Food, Chemical, Pharmaceutical, IT, Power, Energy, etc), Pure Sciences or equivalent. Min. ISO 9001 LA training/qualification is required. Role & responsibilities Preparation of Audit Plan as per schedule Auditing as per applicable accreditation rules, scheme-owner requirements & KPIs (where applicable) and TUV India/TNCERT procedures (as relevant) Timely Audit Reporting, including closure of nonconformities within defined time frames Ensure audit workflow completion (incl. OPE workflow) within the specified timelines and within the Excellence tool. Address technical review comments on priority to facilitate efficient & timely certificate issuance to the clients. Attend Exchange of Experience/Calibration meet and ensure CPD compliance as required by the respective schemes, including ensuring the timely renewal of qualifications Develop and enhance competence over a period in various sectors. Support in Key Account Management for the clients assigned for value added services Preferred candidate profile

Long Description To conduct in- process audits / periodic system audits / facility audits in Clinical research department. Review Clinical/Clinical Data Management raw data (Retrospective Audits) of Clinical DepartmentTo verify the logbook and related equipment used for study. To prepare and generate the SOPs To check and verify the instrument calibration records To check the training records and its compliance Review of Protocols, TLFs and CSR of all inhoused /outsourced BA/BE studies in compliant to regulatory requirements and release of QA Authentication Ensure the archival of the data is done as per in-house SOP Hosting an external audits or a third party audit. Any other responsibilities assigned by Head Quality Assurance as per study requirements Education Post Graduation in Pharmacy Work Experience 3-5 Years of Experience in conducting QA Audits in Clinical department in a consistent manner to ensure that the facility is compliant with established procedures and applicable regulatory guidelines Good Knowledge on Review of calibration records of all instruments pertaining to Clinical Research department QA work Experience with good understanding on the Quality Management system process. Good Communication, Computer Skills

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 5 - 6 Yrs in shop floor management. Must have hands on experience in Granulation Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim

HIRING! We are Hiring for Quality Assurance Department with OSD Background: QUALITY ASSURANCE Open Positions: Officer/Sr. Officer - 2 to 7 years Desire Profile : 1. Hands on experience of review of batch record and COA. 2. Well-versed in schedule M and others regulatory guidelines. 3. Knowledge of export documentations. 4. Exposure of handling regulatory and customer Audits. Interested candidates may share updated resume at hr.plant@zuventus.com

Urgent Required Sr. Quality Engineer in manufacturing company for Chimbali, Pune location. Required Qualification: Diploma / BE Preferred candidate from Automotive industry. Required Experience - 2 Yrs. - 4 years Role & responsibilities 1. Handling Incoming quality inspections team. 2. PDIR for each supply 3. Excellent communication skills and interpersonal skills. 4. Should be able to coordinate with end customer independently for any customer complaint / requirement. 5. Good in MIS preparation. 6. Knowledge of QMS, ISO, IATF and other quality standards. 7. Developing and implementing quality standards and quality control systems 8. Monitoring and analysing quality performance. 9. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. 10. Collaborating with operations team to develop and implement controls and improvements. 11. Ensuring that workflows, processes, and products comply with safety regulations. 12. Investigating and troubleshooting product or production issues. 13. Developing corrective actions, solutions, and improvements. 14. Reviewing codes, specifications, and processes. 15. Strong analytical and problem-solving skills..

Experienced Candidates in QA as per ISO 13485 review batch records, handle deviations, CAPA, and audits; support validations; write and maintain SOPs; coordinate with cross-functional teams, documentation, and Compliance with regulatory standards. Required Candidate profile Graduate / Post Graduate in biotechnology / bio medical / Microbiology / Chemistry with strong hands on experience in QA operations in any Pharma or medical devices company.

Hands-on experience with various inspection and measurement tools (callipers, micrometres, height gauges, CMM, profilometer etc.). Experience with Quality Management Systems (QMS) such as ISO 9001, & preferably IATF 16949. Training & Compliance Required Candidate profile Familiarity with core quality tools: APQP, PPAP, FMEA, MSA, SPC. Knowledge of root cause analysis and problem-solving methodologies (e.g., 8D, PDCA). Quality Control and Inspection

Roles and Responsibilities Ensure compliance with quality management systems (QMS) and quality control measures (QC) on MEP works. Conduct regular site inspections to identify non-conformities and implement corrective actions. Develop and maintain quality documentation, including test reports, certificates, and records. Collaborate with customers to resolve issues related to product defects or performance concerns. Desired Candidate Profile 5-10 years of experience in QA/QC engineering role for MEP projects. Diploma/B.Tech/B.E. degree in Electrical or Mechanical field from a recognized institution. Strong knowledge of ISO Systems, QAP (Quality Assurance Program), QMS (Quality Management System), QC Inspection, Non Conformity Management, RCA (Root Cause Analysis). Excellent customer coordination skills with ability to handle customer complaints effectively.

Job Title: Quality and Regulatory Manager (Medical Devices) Reports to: Director of Quality / Head of Operations Job Summary The Quality and Regulatory Manager is responsible for ensuring that all medical device products comply with global regulatory requirements (e.g., US FDA, EU MDR, ISO 13485), maintaining effective quality management systems, and facilitating successful regulatory submissions. The role involves leading internal and external audits, managing documentation, and supporting cross-functional teams to ensure the safety, efficacy, and compliance of medical devices throughout the product lifecycle. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations. Lead internal and external audits, and manage corrective and preventive action (CAPA) processes. Ensure proper documentation, control, and retention of quality records and regulatory files. Oversee product nonconformance investigations and ensure timely closure of deviations. Regulatory Affairs: Prepare, compile, and submit regulatory filings (510(k), CE Mark Technical Files, etc.) for new and existing products in global markets. Monitor and interpret global regulatory changes, ensuring the company remains in compliance. Serve as primary contact for regulatory agencies and notified bodies during inspections and audits. Develop and maintain product registration dossiers and technical documentation. Risk Management: Lead risk management activities in accordance with ISO 14971, including hazard analysis and post-market surveillance. Support product recalls, field safety corrective actions, and complaint investigations. Training & Continuous Improvement: Train and mentor staff on quality and regulatory requirements. Drive continuous improvement initiatives for product and process quality. Cross-Functional Support: Collaborate with R&D, Manufacturing, Supply Chain, and Marketing to ensure compliance in product design, labeling, packaging, and advertising. Support new product development teams with regulatory strategy and submission pathways. Qualifications & Requirements Bachelors or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field. Minimum 2 years’ experience in quality and/or regulatory roles in the medical device industry. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards/regulations. Experience preparing regulatory submissions (510(k), PMA, CE Mark, etc.). Lead Auditor certification for ISO 13485 (preferred). Excellent written and verbal communication skills. Strong organizational and project management abilities. Key Competencies Detail-oriented and analytical. Problem-solving and decision-making skills. Ability to work cross-functionally and lead teams. Up-to-date with global regulatory trends and requirements. Location: [Insert location] Employment Type: [Full-time/Part-time/Contract] Let me know if you want to add anything about company culture, reporting structure, or specific product lines!

Key Responsibilities: NABH Implementation & Compliance Assist in planning, implementing, and maintaining NABH standards across departments. Coordinate periodic gap analyses and action plans. Maintain all required manuals, SOPs, and policy documents in line with NABH guidelines. Conduct internal quality audits and facilitate external NABH Audit. Documentation & Data Management Ensure timely updation of quality documentation and departmental records. Maintain records for clinical and non-clinical indicators, risk management, and patient safety. Prepare reports and dashboards for management review. Training & Capacity Building Organize training programs on NABH standards, patient safety, and infection control. Ensure training compliance and maintain training records for hospital staff. Quality Indicators & Performance Monitoring Monitor departmental KPIs and hospital-wide quality indicators. Analyze trends and suggest improvements to reduce adverse events, near misses, and sentinel events. Coordination & Support Serve as liaison between departments and the quality team. Assist departments in implementing corrective and preventive actions (CAPA). Facilitate mock drills, audits, and committee meetings (e.g., Quality, Safety, Infection Control).

Role & responsibilities Conduct Department Wise Audits to check whether they are working as per their SOP or not and to find the scope of improvements in their existing processes. (Sales, Pre Sales, Project-CD, Project-CR, Design-CD, Design-CR, Purchase, Quality, Production, Assembly, Packing-CD, Packing-CR, Store, Maintenance, HR, IT, HSE, Dispatch) Record and formalize the findings and submit the formal Audit Report to the respective Process Owner with a deadline and rating for improvement Keep a track of timely closure of these Audit ratings and closure evidences and send repeated reminders and status updates to the concerned person on every Monday. Escalate the non-submissions/delayed submissions report to the Management on every Saturday. Help the concerned person in updating their Processes/SOPs/Rules in standard PWSPL formats and get the new Process Document signed by impacted Internal Users and announce the same as an updated process to all impacted users. Write detailed Procedures and SOPs as per Company/Department gaps and circulate with concerned departments after their signoff to ensure their's no re-occurence of gap. Any additional travel to Project Sites to identify issues/non compliances and perform RCA and CAPA on the same. Keep centralized tracking of all company procedures, documents, with their latest revisions, revision history of changes, Audit reports, Audit Action Closure Tracker, etc in a systematic manner to be presented to management in weekly review meetings as & when required. Preferred candidate profile ISO 9001 Lean Manufacturing Quality tools Good Spoken and Written English Communication Documentation & Reporting Quick Learner Risk Identification and Mitigation Ability to match Organizations Quality Vision Self-Motivation MS Office Suite 5S Kaizen CAPA QMS Knowledge Adaptability Team Management Gap Analysis Continuous Improvement Time Management HSE Leadership Quality Standard Eye for Detail Knowledge of measuring tools Analytical & mathematical aptitude Interpersonal Coordination Decision making Pro activeness

Greetings from HCL! Currently Hiring for "Compliance" JD: Stakeholder Management Excellent Oral and Written communication. Extensive experience in directly working with customers Periodic Review Hands on experience in conducting Application Periodic Reviews Manage Periodic review processes including scheduling, conducting and reporting of Periodic reviews Documenting process gaps and working with stakeholders to rectify them Experience in analyzing risks and working with stakeholders for mitigations Deviation Performs Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS system Collaborates with multiple stakeholders in recording, managing deviation Supports as required in Route Cause Analysis (RCA) process using QMS specified method to manage Deviation Ensures Deviations are linked to CAPA and Effectiveness Check Ability to communicate and manage multiple stakeholders across different spectrum CAPA Adept in using CAPA management module using TrackWise or any eQMS system Creates requests for Due Date Extension” or “Cancellation” requests for CAPA as per the stakeholder request Tracks all CAPA, Deviations to closure without any timeline deviations Provides trend analysis of CAPA to identify patterns and to measure effectiveness check Proactively escalates necessary communications to ensure CAPA is timely managed Proactively communicates and excels in stakeholder management Supplier Assessments Extensive knowledge and experience in conducting supplier assessments Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Quality Mgr, Pharma, 14+yrs exp in pharma sector a must (age max 45yrs) Strong quality assurance/ QC, sqa,qms, pharma quality operations, compliance, audits, documentation, reporting, etc. latest pharma quality (QC) practices exposure - a must

Quality manager, Manage overall QMS - qc, qa, sqa, line quality, RCA, Documents, audits, strong knowledge of either Powder Coating, Liquid Painting , Zinc Electroplating, CED, work exp of JBM, Delphi, Badwe, Panse preferred

Role & responsibilities Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc. Responsible for review and approval of all continual improvement projects affecting quality at a site Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations Review of all documentation (i.e. LIR, OOS, Change Controls, etc.) Ensuring quality interface with internal and external customers when dealing with activities such as service requests, issue resolution, complaints, product information, or for movement of materials, products, or process from site to site Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Responsible for Performing, reporting of observations and verification of compliance reports of internal audit

1. To review and to carry out the assessment of Change control, Deviation, CAPA, OOS, Internal Audit, Market complaints Product Recall 2. To prepare QMS trends QMS metrics, 3. To conduct the Quality Review Meeting and coordination with CFT members. 4. Knowledge in usage of Power BI tools QMS data Graphical representation