1010 Qms Jobs

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

Supervise daily quality inspections during order picking • Conduct daily pre-despatch quality checks on all product lines picked for Progressive orders. • Conduct Incoming shipment/delivery quality inspections on all produce lines • Conduct in store inspections to assess fruit quality and handling of Glassfields and competitors product at store level. • Provide accurate and timely Quality reporting • Manage and update all forms and record keeping of quality • Oversee all on HOLD/REJECT product and ensure audit trails • Ensure record keeping and filing is correct and consistent and that all records are following Seeka procedures • Management of quality manual systems and compliance • Ensure fresh produce quality standards are maintained at site level • Minimize loss of fresh produce waste through poor handling and storage practices and sign off on all product dumped due to poor quality. • To oversee training of Warehouse Staff performing quality inspections • Oversee and check the setup of the QC area for equipment, calibration of scales, stationary, forms and files • To undertake other duties as requested • Ensure an uncompromising approach is taken to food safety by all employees. This will be achieved by ensuring recognised food safety requirements are complied with at all times and nothing is done that may compromise any market access accreditation

Responsibilities: *Prepare quality system documents * Lead quality assurance initiatives * Ensure compliance with QMS standards * Conduct regular audits & inspections * Manage QA processes & resources Health insurance Employee state insurance Maternity policy Annual bonus Performance bonus Provident fund Gratuity Maternity leaves Paternity leaves Job/soft skill training

BUILD CAREER WITH CHIRON ! WALK IN INTERVIEW On 29 June 2025, Sunday TIME: 10:00 AM to 2:00 PM MANUFACTURING Qualification: M.Sc / B.Sc (Micro, Biotech, Virology, Biochemical) / B.Tech / Diploma/ BE Experience 0 5 Years Production: Drug substance Qualification: M.Sc / B.Sc (Micro, Virology, Biochemical) / B.Tech / Diploma Sterile aseptic operation Autoclave /DHS operation Automated CIP/SIP operation Cell culture Aseptic operation Zonal Centrifuge operation Facility commissioning QMS/ Deviation/ Change control/ CAPA/ Investigation of deviation

Coats is a world leader in thread manufacturing and structural components for apparel and footwear, as well as an innovative pioneer in performance materials. These critical solutions are used to create a wide range of products, including ones that provide safety and protection for people, data and the environment. Trusted by the world's leading companies to deliver crucial, innovative, and sustainable solutions, we provide value-adding products including apparel, footwear and specialty threads. With a proud heritage dating back more than 250 years and a spirit of evolution to constantly stay ahead of changing market needs, we have operations across 50 countries with a workforce of over 17,000, serving our customers worldwide. Following the acquisition of Texon and Rhenoflex, new Coats Footwear now has a complete range of footwear components to meet your needs, from heel counters to toe puffs and everything in-between. Through our technologically diverse product portfolio, we can cater to both current and future trends, setting new standards in the process, turning customer ideas into a reality and accelerating sustainability. Headquartered in the UK, Coats* connects talent, textiles, and technology to make a better and more sustainable world. For more info, visit our website: www.coats.com Job Description: Assistant Manager - Fabric Quality Assurance Role Purpose: To ensure the consistent delivery of high-quality aramid fabrics by implementing and overseeing robust quality assurance systems across spinning, twisting, weaving, and dyeing processes. This role is essential in maintaining compliance with industry standards, customer specifications, and internal benchmarks, while also driving continuous improvement initiatives. Key Responsibilities: Quality Assurance Management Develop and implement quality control plans for aramid spinning, twisting, weaving, and dyeing processes. Monitor in-process and final fabric quality to ensure conformity with technical and customer specifications. Manage root cause analysis and corrective/preventive actions (CAPA) for quality-related issues. Process Auditing & Compliance Conduct regular internal audits across all stages of fabric production. Ensure compliance with ISO, OEKO-TEX, and other relevant standards. Collaborate with production teams to close quality gaps and drive process adherence. Customer & Certification Interface Act as the quality interface for key customers and external audits. Support technical documentation and lab testing for customer approvals and certifications. Data Analysis & Reporting Track key quality metrics (e.g., defect rates, first-pass yield, claims) and present insights to leadership. Use statistical tools and Six Sigma principles to drive continuous improvement. Team Leadership & Training Lead and develop a team of QA inspectors and technicians. Conduct training on quality standards, defect identification, and problem-solving tools. Key Skills & Competencies: Strong technical knowledge of aramid fiber properties and processing behavior. Deep understanding of textile quality systems, standards, and testing methods. Proficiency in weaving and dyeing defect analysis, shade control, and process stability. Excellent analytical, communication, and leadership skills. Familiarity with Lean, Six Sigma, or other quality improvement methodologies. --- Qualifications & Experience: Degree in Textile Engineering / Technology or equivalent. Minimum 10 - 15 years of relevant experience in aramid-based fabric manufacturing. Proven track record in a similar QA leadership role within technical or protective textiles. At Coats Group, we are committed to innovation, excellence, and fostering a diverse and collaborative environment where every team member can thrive. If you are passionate about making an impact in the textile industry and eager to join a global leader with a rich heritage and a forward-thinking approach, we invite you to take the next step in your career with us. Apply now to be part of our dynamic team and help shape the future of textiles.

QMS Experience of IATF EMS Certification Audits, Internal Auditors in IATF and EMS Certification. Sound knowledge of PPAP, 8D, MSA, SPC,7 QC Tools, DOJO training module SAP QA module AutoCAD Drawing awareness, change systems, 5S, safety.

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

Role & responsibilities Quality policies and programs : Develops, implements, monitors, maintains and improves the quality policies and the quality Manual, in coordination with the HOD & Handle the Production Process, Incoming Quality and leading the QMS for the entire organization, according to the global standard, in order to ensure an adequate quality assurance system by which the certificates are retained. Prepares improvements to the quality policy, tracks developments on quality and includes these in the policy, in accordance with internal and external standards and divisional / group QA policies. Quality Systems / certificates and continuous improvement : Establishes and maintains the quality management system in which all procedures and process descriptions are defined according to the requirements of the relevant standards and schemes within the organization so that understanding the processes and division of responsibilities arises and continuous quality can be guaranteed and the relevant certificates are retained. Drives continuous improvement processes in the organization, promoting and supporting the team members and improve the processes with HOD guidelines. Conducts risk-based assessments / improvement programs to minimize impact of any process and product deficiencies Liaises with relevant departments, collects data, relevant for the quality systems, from departments and ensures that all data included in the quality systems are up-to-date Quality Control : Drafts and ensures compliance with the procedures for the implementation of quality control of incoming and manufactured goods and in-process controls, in accordance with the organization guidelines and relevant standards and schemes. Similarly, with regard to the procedures for the processing of products that do not meet the specification, in order to ensure that the products meet the required quality with minimization of costs. Communication : Promotes all aspects of Quality Assurance with all relevant departments, supports the communication of quality programs and standards to the organization, and may coordinate training in relevant areas. Organizes local Quality Assurance boards and / or participates in internal or external QA bodies Participates in crisis situations (contaminations, severe product defects, etc.) in the relevant crisis teams in order to mitigate / control adverse effects for the organization and / or conduct root cause analyses to prevent incidents recurring Complaints handling : Ensures the treatment and (root cause) analysis of product complaints, so that corrective and preventive measures can be initiated. Analysis the complaints of based on the customer support feedback and close with defined lead time with out recurrence. Audits Organizes and guides internal and external audits, according to the guidelines of quality systems, so that the quality procedures are complied with, with the aim of maintaining the quality certificates. Executes internal audits as well as external audits, in coordination and consultation with external auditors. Reports the outcome of audits to the relevant stakeholders, monitors any follow-up actions Preferred candidate profile : Experience in Supplier Quality Management, Incoming Goods Inspection (covering Electronics, Mechanical, PCB, Cables, Standard and Custom parts) Experience in Mass Production Quality activities. Good working knowledge of ISO9001, ISO14001, and ISO 18000 certifications Good knowledge of 5S, Kaizen, SPC, Lean & Six Sigma techniques. Good knowledge of Control plans and FMEA. Purpose of the Job: Responsible for the development, implementation and monitoring of all internal Quality Assurance plans and programs necessary for the relevant markets Nutreco serves, contributing to the realisation of organisations goals and objectives. This is achieved by safeguarding the desired internal and external quality levels of products and processes and services and retaining all relevant certificates required in order to meet global and local standards and schemes. Quality management is focused not only on product/service quality, but also on the means to achieve it. Quality management therefore uses quality assurance and quality control of processes as well as products to achieve a more consistent quality. He / She direct an entitys inspection and testing programs, as well as its proactive quality assurance procedures designed to prevent defects and / or improve performance. In pursuing these objectives, he / she manages the department's employees and interacts with other managers and staff in departments that run processes where quality is an important dimension with external & Internal Parties. (e.g. production, research, supply chain, Vendor etc.).

ENVIRONMENTAL HEALTH AND SAFETY RESEARCH & DEVELOPMENT CENTRE is looking for Quality Manager to join our dynamic team and embark on a rewarding career journey Develop and implement quality management systems and processes. Conduct quality audits and inspections. Monitor and analyze quality performance metrics. Collaborate with cross-functional teams to address quality issues. Provide training and support on quality standards and procedures. Ensure compliance with regulatory and quality standards. Stay updated with industry trends and best practices in quality management. Qualification : M.Sc / Phd / M.Tech

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation Development Quality Assurance Department (Formulation) Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDR’s, MFR’s and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Should have experience in IPQA and Analytical QA (OSD/Injectable) Ref to Friends or colleagues. Please Share me update resume: careers@biophore.com Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Record to Report - DOP. Experience1-3 Years.

Role Purpose The purpose of the role is to support process delivery by ensuring daily performance of the Production Specialists, resolve technical escalations and develop technical capability within the Production Specialists. Do Oversee and support process by reviewing daily transactions on performance parameters Review performance dashboard and the scores for the team Support the team in improving performance parameters by providing technical support and process guidance Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Ensure standard processes and procedures are followed to resolve all client queries Resolve client queries as per the SLAs defined in the contract Develop understanding of process/ product for the team members to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by monitoring compliance with service agreements Handle technical escalations through effective diagnosis and troubleshooting of client queries Manage and resolve technical roadblocks/ escalations as per SLA and quality requirements If unable to resolve the issues, timely escalate the issues to TA & SES Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Troubleshoot all client queries in a user-friendly, courteous and professional manner Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract SLAs Build people capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Mentor and guide Production Specialists on improving technical knowledge Collate trainings to be conducted as triage to bridge the skill gaps identified through interviews with the Production Specialist Develop and conduct trainings (Triages) within products for production specialist as per target Inform client about the triages being conducted Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Identify and document most common problems and recommend appropriate resolutions to the team Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback, NSAT/ ESAT2Team ManagementProductivity, efficiency, absenteeism3Capability developmentTriages completed, Technical Test performance Mandatory Skills: COBOL. Experience5-8 Years.

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls. Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms. Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up. Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications. Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness. Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.

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.

Handling of customer audit, ISO9001:2015, IATF 16949:2016 surveillance audit and closure of audit points.Monitoring of IQC, PQC & OQC.Implementation & testing according to the BIS standard IS 15644:2006, IS 9873 Part 1,VDA 6.3 process audit.

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

Exemed Pharmaceuticals is looking for QA Sr Executive – Luna to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Role: We are looking for a in process quality engineer to monitor and improve the quality of our operational processes and outputs. The quality engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures. Responsibilities: To assist the Implementing quality standards & quality control systems Monitoring and analyzing quality performance. Responsible for conducting Process audit, Product audit & Dock audit & timely closing all gaps. Responsible for reduction Inhouse rejection PPM. Responsible organize internal audits as per plan & timely closing all gaps. Awareness of 7QC tools & Handling Daily NCs Daily review of quality issues conducts defect analysis for internal complaints by using Problem solving tools. Effective implementation of MSA and SPC studies. Monitor the entire production cycle and perform regular tests or inspection to identify potential malfunctions as early as possible. Ensuring that workflows, processes, and products comply with safety regulations. Developing corrective actions, solutions, and improvements. Reviewing specifications, and processes and POKA-YOKE and QMS. Awareness & effective implementation of standard requirements as per ISO 9001, IATF 16949.

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. Experience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. E xperience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Experience with quality management software (e.g., QMS, EQMS)

In this pivotal Senior Manager Quality Assurance role within our IT Quality organization in Hyderabad, you'll be a leader, driving the execution of complex assignments that demand strategic planning and the development of innovative techniques. Your primary focus will be overseeing and mentoring a team of quality professionals, ensuring meticulous internal reviews and risk assessments of GxP systems, all in accordance with Amgen's policies and procedures. Focus Areas: Computer System Validation (CSV) : You'll bring a strong understanding of regulations like 21 CFR Part 11, EU Annex 11, and GAMP standards . Periodic Reviews and Audit Trail Assessments : Ensure compliance, system integrity, and risk identification for computer system validations. Supplier Relationships : Manage software application suppliers, including vendor selection, qualification, contract management, and ensuring timely, quality software delivery. Quality Management System (QMS) : Oversee the QMS for computerized systems, focusing on compliance, documentation, and continuous process improvement. Responsibilities: Possess strong project management skills with experience supervising quality professionals who collaborate with cross-functional and global stakeholders across multiple time zones. Develop, mentor, and oversee staff and day-to-day GxP activities . Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews . Manage change controls, validation, and review and approval of validation deliverables (e.g., Validation Plan, Test Strategy, Validation Summary Report, etc.). Handle Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g., Equipment, Analytical, etc.). Support, review, and approve failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Perform Business Owner activities for systems owned by Quality Assurance (e.g., SAP QM, Veeva, Kneat). Participate in and support regulatory inspections as needed. Utilize tools and systems such as HP ALM, Jira, Confluence, TrackWise, and Documentation Management Systems . Example Tasks for the Position: Possess a strong understanding of Risk Assessment and how to apply risk-based decision-making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables, and/or QMS-related records (Deviation/CAPA). Review and approve System Life Cycle Documents (i.e., Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverage qualitative insights and quantitative research, analyze trending data, and utilize forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipate and prevent potential problems. Independently develop solutions that are thorough, practical, and consistent with functional objectives. Provide management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to management's attention and initiate and enforce necessary improvements and corrections to established systems and process compliance. Basic Qualifications: Master's degree with a minimum of 10 years of experience in Software and Systems Quality Assurance (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration) OR Bachelor's degree with a minimum of 14 years of experience in Software and Systems Quality Assurance (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration). Strong understanding and ability to apply GxP requirements in Information Systems. Possess a strong understanding of industry standards and business principles. Contribute to work group/team by ensuring the quality of tasks/services provided by self and others. Ability to work hours outside the standard workday or in different time zones to support business needs. Preferred Skills: Demonstrated experience (3-5 years) training others in the activities outlined above. Ability to establish/improve and actively participate in training curriculum and delivery of this material.

Role & responsibilities Implement and maintain QMS processes across e-bike and battery manufacturing operations. Prepare and maintain quality documentation (SOPs, Control Plans, Process Flows, FMEAs, etc.). Conduct internal quality audits and coordinate external/third-party audits (e.g., ISO, BIS, etc.). Monitor KPIs related to qualitydefect rates, customer complaints, supplier rejections, etc. Lead root cause analysis (RCA) and corrective/preventive action (CAPA) processes. Collaborate with Production, R&D, and SCM to ensure quality standards at all stages. Ensure calibration and verification of testing and measurement equipment. Support training programs on QMS awareness and implementation for staff. Preferred candidate profile achelors degree in Mechanical/Electrical Engineering or equivalent. 25 years of experience in a QMS role, preferably in automotive or battery manufacturing. Knowledge of ISO 9001, IATF 16949, ISO 14001; BIS & battery safety standards preferred. Strong analytical, documentation, and communication skills.

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

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.