427 Capa Jobs - Page 4

We are looking for a meticulous Quality Manager to champion quality assurance initiatives at Solon India Pvt Ltd, ensuring our solar EPC projects meet the highest standards of excellence. As Quality Manager, you will spearhead the development and implementation of robust quality control frameworks, conduct rigorous audits and inspections, ensure compliance with technical specifications and relevant IEC and other international standards, and enhance both product and process quality. Your role is pivotal in driving continuous improvement and optimizing quality procedures while maintaining cost-effectiveness. You will collaborate closely with cross-functional teams, including engineering, procurement, and construction, to foster a culture of quality throughout the organization. The ideal candidate will possess a strong understanding of solar PV systems, proficiency in quality assurance tools, and a proven track record in implementing continuous improvement strategies within the renewable energy sector. This role demands a detail-oriented professional capable of mitigating risks, standardizing documentation, and leading training sessions to promote quality awareness and best practices. Your expertise will directly contribute to project success, client satisfaction, and the overall reputation of Solon India as a leader in renewable energy solutions. Job Details: Industry: Renewable Energy Department: Quality Assurance Role: Quality Manager Location: Hyderabad Compensation: 6,00,000 - 12,00,000 per year Experience: 3-8 years Employment Type: Full-time Qualification: Bachelor's/Master's degree in Engineering, Quality Assurance, or a related field Responsibilities: Quality Systems & Compliance Help develop and maintain a quality assurance system for solar EPC projects, ensuring compliance with IEC, IS, and other industry rules. Watch project activities to make sure they follow quality plans and procedures, addressing any issues quickly. Participate in root cause analysis for quality problems, helping to implement corrective actions to prevent them from happening again. Work with teams to maintain a Quality Management System (QMS) based on ISO 9001 standards. Assist with internal audits to check the QMS and find areas for improvement. Prepare regular reports on quality, showing trends and improvement efforts for review. Inspection and Audit Help plan and conduct audits and inspections of solar installations and materials to ensure they meet project and quality standards. Assist in coordinating third-party inspections, ensuring they follow project rules and remain objective. Keep detailed audit records, including reports and corrective action plans. Perform material inspections to ensure they meet technical & safety standards, preventing the use of defective materials. Oversee the inspection of incoming materials to ensure they meet quality standards, working with procurement to resolve any issues. Maintain a list of approved vendors and suppliers, helping with regular performance reviews to ensure consistent quality. Process Optimization and Improvement Look for opportunities to improve quality and reduce costs by analyzing data, using basic statistical techniques to monitor key processes. Work with engineering and procurement to improve vendor quality, helping to implement vendor quality programs. Help establish key performance indicators (KPIs) to track process efficiency, defect rates, and client satisfaction, monitoring performance and assisting with corrective actions. Help standardize documentation, inspection checklists, and testing procedures to ensure consistency. Assist with change management to introduce new quality processes and technologies smoothly. Help develop and implement strategies for reducing defect rates, focusing on preventing defects and improving overall quality. Risk Mitigation & Documentation Help maintain and update the risk register for quality issues, identifying potential risks and helping to implement mitigation strategies. Help develop and standardize documentation, including checklists and testing procedures. Assist with training sessions on quality protocols, continuous improvement, and risk mitigation, promoting a quality-focused culture. Participate in Failure Mode and Effects Analysis (FMEA) to identify potential failure points and help implement preventive measures. Help manage non-conformity reports, ensuring issues are resolved and corrective actions are tracked. Ensure compliance with regulations and industry standards, staying updated on changes and helping to implement necessary adjustments. General Expectations and Past Experiences: Possess a Bachelor's degree in Engineering (Mechanical, Electrical, or related field) with 3-8 years of experience in quality assurance within the renewable energy sector, specifically solar EPC projects. Demonstrated expertise in quality assurance methodologies, quality control techniques, and Corrective and Preventive Action (CAPA) implementation. Proven ability to manage vendor quality, conduct audits (ISO 9001 preferred), and implement Quality Management Systems (QMS). Strong analytical skills with proficiency in statistical process control (SPC) and data analysis for performance reporting and defect rate reduction. Experience in facilitating Root Cause Analysis (RCA) and implementing effective Risk Mitigation Strategies in EPC projects. Excellent communication and stakeholder management skills, with the ability to lead training sessions and drive Client Satisfaction Improvement Initiatives. Familiarity with Construction Material Inspection & Testing procedures and Failure Mode and Effects Analysis (FMEA).

We seek a meticulous Quality Engineer to champion quality excellence in our expanding renewable energy projects at Solon India Pvt Ltd. As a Quality Engineer, you will play a crucial role in ensuring the planning, procurement, installation, and commissioning phases of our solar power projects meet the highest quality benchmarks. Your responsibilities will include developing and implementing QA/QC plans, conducting rigorous inspections of incoming materials and site installations, and maintaining comprehensive Quality Documentation. You will collaborate closely with cross-functional teams, including procurement, design, and site execution, to enforce compliance with ISO 9001, IEC, IS, and other relevant industry standards. Identifying and addressing recurring quality issues through root cause analysis and Corrective and Preventive Actions (CAPA) will be key to your success. The role also involves supporting Vendor Qualification, internal and external audits, and driving continuous improvements to enhance project quality and reliability. You will also be responsible for implementing SOPs and Standard Templates and can suggest improvements. If you are passionate about sustainable energy and committed to delivering reliable and efficient solar power systems, we encourage you to apply and contribute to our mission of powering a greener future. Job Details: Industry: Renewable Energy Department: Quality Assurance/Quality Control Role: Quality Engineer Location: Hyderabad Compensation: 3-7 LPA Experience: 1-4 years Employment Type: Full-time Qualification: Bachelor's/ Master's degree in Electrical/Mechanical Engineering or related field Responsibilities: Quality Planning and Documentation Develop, implement, and maintain project-specific Quality Assurance and Quality Control (QA/QC) plans in alignment with project requirements and industry best practices. Maintain comprehensive Quality Documentation, including checklists, Inspection Test Plans (ITPs), Non-Conformance Reports (NCRs), and calibration records. Ensure all quality records are meticulously maintained, readily accessible, and traceable throughout the Engineering, Procurement, and Construction (EPC) lifecycle. Implement and improve Standard Operating Procedures (SOPs) and standard templates to streamline quality processes and ensure consistency across projects. Inspection and Testing Conduct thorough Incoming Material Inspection for critical components such as modules, inverters, structures, and cables to verify compliance with specifications and quality standards. Oversee and monitor civil and electrical work at project sites to ensure workmanship aligns with design specifications, industry codes, and established quality benchmarks. Perform random checks and audits at various project stages, including civil foundation, structure erection, module mounting, and cabling, to identify and address potential quality issues proactively. Coordinate and supervise third-party inspections and testing activities to ensure objective assessment and validation of project quality. Ensure all inspection and testing equipment is properly calibrated and maintained to ensure accurate and reliable results. Document all inspection and testing results meticulously and communicate findings to relevant stakeholders promptly. Compliance and Standards Ensure strict compliance with ISO 9001, IEC, IS, and other applicable industry standards and regulatory requirements throughout the project lifecycle. Liaise with vendors and contractors to enforce adherence to established quality benchmarks, specifications, and contractual obligations. Support internal and external audits, certifications, and regulatory inspections by providing necessary documentation, data, and support. Monitor and track changes in industry standards and regulations to ensure project compliance and alignment with evolving requirements. Develop and improve corrective action plans to address non-compliance issues identified during audits or inspections. Maintain up-to-date knowledge of relevant standards and regulations and provide guidance to project teams on compliance requirements. Problem Solving and Continuous Improvement Conduct thorough root cause analysis of defects, failures, or non-conformances to identify underlying causes and implement effective Corrective and Preventive Actions (CAPA). Identify recurring quality issues and recommend process improvements, procedural enhancements, and training initiatives to prevent future occurrences. Work collaboratively with procurement, design, and site execution teams to enhance project quality through proactive problem-solving and continuous improvement efforts. Track and monitor the effectiveness of corrective actions and preventive measures to ensure sustained improvement in project quality. Participate in regular quality review meetings to discuss project performance, identify areas for improvement, and share best practices. Promote a culture of continuous improvement and quality excellence throughout the organization by encouraging employee involvement and feedback. Vendor Qualification and Management Develop and improve the Vendor Qualification process to assess and select suppliers based on their ability to meet quality requirements and project specifications. Conduct regular audits of vendor facilities and processes to ensure compliance with quality standards and contractual obligations. Collaborate with procurement teams to negotiate quality agreements and performance metrics with key vendors. Monitor vendor performance and address any quality issues or non-conformances promptly. Provide technical support and guidance to vendors to improve their quality processes and capabilities. Maintain a database of qualified vendors and track their performance over time. General Expectations and Past Experiences: Possess 1-5 years of experience in QA/QC roles within solar EPC, renewable energy, or infrastructure projects. Demonstrate a strong understanding of solar power systems, components, and the project execution lifecycle. Exhibit in-depth knowledge of QA/QC procedures, ISO standards, and industry codes (IEC, IS). Proficient in Incoming Material Inspection, Site Inspections, and Compliance Management. Experienced in the Development of SOPs and Standard Templates. Capable of conducting Root Cause Analysis and implementing Corrective and Preventive Actions (CAPA). Skilled in utilizing Document Management Systems (DMS) and applying Sound Quality Control principles.

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Validation Engineer What you will do Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. QA Manager What you will do Role Description: In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited tosupplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams Roles & Responsibilities: Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner. Ensure team members are appropriately qualified and trained to perform needed activities per company procedures. Conduct goal setting, performance reviews, and compensation planning to align with organizational goals. Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements. Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation. Develop, monitor and report metrics to senior management to assess the health of the team’s performance. Develop solutions that are thorough, practical, and consistent with functional objectives. Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in quality management systems or a related field OR Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Experience managing staff in a GXP environment Functional Skills: Must-Have Skills: Working foundation in quality assurance roles and proven team leader. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Specialist Quality Assurance - Global Supply Quality What you will do Let’s do this. Let’s change the world. In this vital role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers. Roles & Responsibilities: Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type. Documentation review and approval includingsupplier records, investigation reports, Amgen quality records, and validation records. Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles Oversight and completion of supplier assessments and documentation to support product complaints. Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Review and approval of change control records for supplier changes. Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Develop solutions that are thorough, practical, and consistent with functional objectives This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree with 4+ of experience in quality management systems or a related field OR Bachelor’s degree with 6+ years of experience in quality management systems or a related field OR Diploma with 8+ years of experience in quality management systems or a related field. Preferred Qualifications: Must-Have Skills: Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Good-to-Have Skills: Experience in creating digital solutions and working within computerized systems Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes and regulatory requirements (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, and combination products). Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Role & responsibilities Hands on experience on various production processes like castings, forging, press parts, heat treatment, painting, zinc flake coating and assembly. Explore various suppliers for the outsourcing processes and conduct capacity and capability assessment. Co-ordinate with SCM and suppliers for commercial settlements. Co-ordinate and liaison with various suppliers for outsourcing of parts. Capacity planning at suppliers against the target requirements. Prepare Monthly plan of outsourcing parts and monitoring it on daily basis. Arranging and sending the material to various suppliers for further processing. Planning and scheduling the material deliveries from suppliers as per project plans. Resolve the quality issues at suppliers and CAPA initiations. If required, involve QA to resolve the issues with suppliers. Plan and arrange Inspection by QA at suppliers if required. Co-ordinate and liaison with suppliers for new product development Responsible for zero customer complaints in outsourced parts received from suppliers Rejection analysis and CAPA initiation at final inspection. Customer Complaint Analysis and CAPA initiations. Implement improvement initiatives at supplier for cost reduction and quality improvements. Internal Auditor for ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 Preferred Candidates is Male only.

Role & responsibilities Lead the FAT & Final Inspection Team. ( 4-6 Members ) Co-ordinate and liaison with customer / TPIs for conducting Factory Acceptance Tests. Planning, scheduling & conducting Factory Acceptance Tests Inspection and test reports submission and approvals from customer Co-ordinate and liaison with Project Management Team for inspection calls to customer / TPIs. Provide necessary assistance to Engineering team in new projects related to inspection, test and test facilities. Submission of New Projects MQP / QAP to Project Management / Customers as per tender requirements. QA Member of New Product Development Team. Support and co-ordination for new development parts. Responsible for final inspection and ensure zero customer complaints. Rejection analysis and CAPA initiation at final inspection. Customer Complaint Analysis and CAPA initiations. Implement 5 S and improvement initiatives in Lab and QA. Responsible for NABL Lab Mechanical Stream testing. Preferred Male Candidates only. shifts details : 3 shifts.

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Marketing Operations - Quality Management Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designAct of overseeing all activities and tasks needed to maintain a desired level of excellence. This may include the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. What are we looking for Quality AnalysisQuality AuditingService Quality ManagementHTML5Hyper Text Markup Language (HTML)Ability to perform under pressureProblem-solving skillsResults orientationCommitment to qualityWritten and verbal communication Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Handling of Quality management system like Market complaints, Change Control, Deviations, OOS, OOT, Incidents, CAPA, Self-Inspection, Vendor Qualification. Review and Approval BMR/BPRs, Prepare of Standard Operation Procedure, Process Validation, Hold Time Study Protocol and Reports, Annual Product Quality Review & trending, Cleaning validation. Qualification/ requalification of Equipments. Release of Finished Product, Continuous Process Verification, Trainings etc.

To review site responses to CAC audit foradequacy & supporting exhibits in ZyACTM. Tracking and review of regulatory/ Corporatecommitments. To organize compliance meeting, follow upmeetings / communication with site and CQ Leads to discuss unresolvedobservations or findings. To Present the progress in monthly reports forthe site (include ZyACTM Response of audit reports) and participation indepartmental meetings. To ensure SOP on Corporate Audit andCompliance is followed effectively. To participate in need based corporate auditsand compliance verification as per schedule. To support site for compliance duringpreparedness and follow up for updates compliance. assignedby management) for adequacy and appropriateness. To identify and escalate specific issue tomanagement for compliance & support. To maintain all portals updated (ZyACTM, CQACalendar, Regulatory commitment) Participation in development of new initiatives Preparation of monthly reports and participationin departmental meetings. Any other task assigned by reporting authoritytime to time for enhancement of compliance. System harmonization-Identification of need,escalation & Tracking for resolution. Travel to multiple sites as per requirement foraudit purpose. Candidate Requirements: Candidate Must have rich experience in API auditand compliances. Must have Excellent Communication, Drafting andInterpersonal skills. Must have experience of audit andcompliances of API. Must be ready to travel on multiple sites foraudit purpose.

Role & responsibilities Quality Engineer 1) Carry Daily Incoming to final inspection . 2) CAPA ,8D for customer complaints 3) Audit awareness 4) Required candidate from sheet metal fabrication manufacturing background 5) Should have awareness of laser cutting, CNC Bending ,Welding and Powder coating process 6) Should have awarenss about Autocad . Preferred candidate profile Sheet metal fabrication manufacturing background. Can speak English Mail your resume to : venkateshengg1@gmail.com

Description External Job Description Assure industrial health & Safety of employees at plant through awareness among employees, audits & inspection, etc Training and Employee involvement 1 Conduct safety Induction program for all new joinees and continuous training programs for all employees working in the plant 2 Conduct Mock drills for emergency situations 3 Attend safety meetings in the plant and close safety points of such meetings 4 Communicate safety arrangements through Displays, Safety Signs, In House Magazines, Safety Literature, Annual Plant Safety Performance Report etc 5 Participate in safety goal/target setting, improvement project, Safety Suggestion Scheme, Safety Promotional activities etc Safety Audits and Inspections 1 Conduct safety inspections and share observation report on daily basis 2 Oversee statutory inspection for all lifting tools& tackles and pressure vessels through third party 3 Comply to ESS and GRC portal 4 Participate in safety audits and implement corrective and preventive actions CAPA for observations of safety audits 5 Process of hazard identification and risk assessment 6 Conduct Job safety analysis for construction activities 7 Conduct statutory assessment of contractor from safety point of view 8 Control contractors through regular monitoring, reward & penalty system and performance review of Contractor 9 Inspect all safety equipment and maintain the same Safety and fire Control system 1 Ensure good health of safety guards, safety interlocks, hand tools and power tools in the plant 2 Ensure 100% compliance with work permit system and safe isolation procedure 3 Observe and control hazardous substances at the plant 4 Procure and maintain personal protective equipment at the plant 5 Monitor noise, ventilation and dust at workplace 6 Inspect electrical equipment and installation 7 Assess fire risk at plant 8 Maintain firefighting equipment Safety performance & measurement 1 Report all incidents including near miss on ESS 2 Investigate all incidents including near miss and maintain data of incident trend analysis 3 Recognize and manage Potential Loss Areas Workplace safety 1 Ensure hygiene & 5S at workplace

Must to have experience into inspection of Fabricated parts at Inhouse, fabricated part Inspection as per Drawing, BOM, basic knowledge of MPI & UT testing. Quality documents requirements of fabricated Parts & Vibrating Screens, CAPA from supplier.

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Handling of Laboratory Incidents, Change Control, Deviations OOS & OOT Handling of CAPA, Coordinate with technical team for timely closure of QMS documents. Writing SOP's. Support Internal & External Audit Finding Responses.

Job Title: Engineer & Sr. Engineer Quality Control Department: Quality Reports To: Manager or Sr. Manager Quality Company Name: Irillic Pvt ltd (part of Motherson group) Job Responsibilities: 1.Perform the Incoming, In-process and Final product inspection. 2.Perform the Supplier qualification and product qualification at supplier end. 3.Maintan the timely calibration for measuring equipments. 4.Perform the process audits. 5.Review the verification and validation plans and reports. 6.Data analytical skills. 7.Knowledge on handling of NC materials and arrange the MRB for timely disposal. 8.Knowledge on CAPA/SCAR preparation or reviewing skills. 9.Knowledge on ISO 9001 and ISO 13485 QMS requirements. 10.Knowlege on Internal audit process. 11.Knowledge on FMEA and Risk Management process as per ISO 14971. 12.Knowledge on Design review process. 13.Knowledge on Change management process. 14.Knowledge on handling the external audits. 15.Knowledge on Process improvement activities. 16.Basic Knowledge on Medical Device Regulatory requirements. Qualification: Diploma in Mechanical or Electrical Or Batchelor Degree in Mechanical or Electrical Engineering. Experience: Minimum of 4 years of experience in medical device manufacturing Quality control. About the Company: Irillic pvt ltd is an Indian med-tech company pioneering in design, development and manufacturing leading-edge technologies in healthcare. In its pursuit of surgical excellence, Irillic leads the way with its Make in India products, transcending boundaries of innovation. With real time intraoperative image guidance that has augmented details becoming an acute requirement for both open and laparoscopic surgeries, it was Irillic s vision primarily to develop a surgical product technology that can enhance outcomes of operative procedures for customers globally. Health & Medical is now a key sector for expansion & growth for our overall group. With an aspiration to “Positively Impact Human Lives Worldwide”. Our global presence and capabilities to manufacture at scale would be complementary to the healthcare industry at large to enable creation of access to quality & affordable healthcare across the world. Our Group was founded in 1975, Motherson is a US$ 10 Billion group consisting of long-standing partnerships with technology leaders worldwide, 190,000+ people, and over 400 manufacturing facilities in 44 countries across the globe. Motherson is a globally preferred supplier to automotive OEMs around the world. Globally, we have large capacities and deep manufacturing expertise in wires and wire harnesses, polymers, elastomers, metals, mirrors, and electronics. This is augmented by our large global product design and engineering team of 500+ people, highly resilient globally local supply chain, global logistics, global sourcing, and global IT and software capabilities delivered through 1800+ IT professionals. We are trusted and well recognized by our customers and partners for our high quality and cost-effective operations. We have partnered with Universities, research centers, start-ups to help them design, develop, manufacture, and commercialize innovative medical devices and equipment globally. As part of our growth strategy we intend to setup exclusive Medical Device Manufacturing Plants in India and the following role would be a requirement for the same.

Job Responsibility: 1.Handling and Monitoring of Supplier related NC for containment action and repairs, RCA and CA, PA through 8D approach and Problem-solving techniques 2.Work and communicate with India DQE and HQ China DQE members time-to-time for category and Components specific Issue resolution be it China or India sourced items 3.Troubleshoot and resolve through containment action for the N&H Assembly Components in areas like Electrical, Mechanical, Gearbox Bearing and Composite and Steel Fabrication, Casting and Fasteners and Generator, Control Panels, Cables etc. especially during incoming and assembly to minimize downtime and ensure the recovery if there any issue on-time and right Quality Repair/Salvage and CA or PA done overall 4.Do time to time required minimum Failure analysis by RCA/QC Tool Approach to improve components receipt Quality Assured for the smooth N&H production 5.Ensure adherence to EHS (Environment, Health & Safety) standards on the supplier activities in shop floor when there is scenario to work / repair / Salvage jointly in-line 6.Collaborate with planning, logistics, and quality departments to manage workflow, resolve bottle necks, and ensure optimal resource utilization. 7.Coordinate daily shop floor activities related to nacelle and hub assembly to ensure timely production targets. 8.Gain and follow and guide suppliers technicians on standard assembly practices, electrical safety, and updated technical procedures. 9.Attitude to learn and adopt and work new skill and new challenges. Job Requirement with Education & Experience: 1.Diploma in Mechanical Engineering or Electrical Engineering or Chemical Engineering 2.5 7 Years of experience in wind turbine manufacturing, assembly, or electrical integration 3.Preferably in Nacelle and Hub production, Process and Supplier Quality etc 4.Experience in coordinating shop floor activities and cross-functional collaboration. 5.Knowledge in Quality Tools like, PPAP, FMEA, Control Plan, 8D, NC and NC Claim etc.

Quality Control Documentation & Procedures: Create and update quality control documentation and procedures to ensure compliance and reflect industry best practices. Regularly review to keep protocols current. Lead Customer and IMS Audits: Conduct and manage customer and IMS audits, ensuring adherence to standards and promptly addressing any issues. Use audit feedback to drive continuous improvement. Real-Time Data Migration: Oversee the migration of electrical data and IV graphs to the cloud, ensuring accuracy and timeliness. Resolve any data migration issues swiftly to maintain system integrity. Calibration Module Availability: Ensure calibration modules are available and functioning properly through regular maintenance and calibration. Coordinate with teams to prevent production delays. Training and Development: Develop and deliver training on calibration and quality control, incorporating industry advancements to enhance staff skills and compliance. Promote continuous learning. Documentation and Reporting: Prepare and maintain reports on calibration and audit activities, ensuring timely and accurate documentation. Provide insights on performance metrics to support decision-making. Key Stakeholders - Internal: Calibration Team Quality Assurance Managers Maintenance Team Production Managers Key Stakeholders - External: Calibration Service Providers Certification Agencies Regulatory Bodies Suppliers

Role & responsibilities Conducting and Documenting Internal and Refresher Trainings Training Coverage and Participant Documentation Issuance and Retrieval of QMS Formats (OOS, Change Control, Deviation, Calibration) Collection, Review, and Archival of Calibration Records Compliance with ISO/IEC 17025, ISO 17034, and ISO 9001 Requirements Issuance and Archival of Instrument Usage and Calibration Logs Preparation and Control of Master SOPs, Specifications, and STPs Withdrawal and Return of Superseded Master Documents Preparation and Distribution of TDS Masters for New Samples Preparation of Protocols and Reports for Qualification/Validation/Verification/Method Transfer Completion and Verification of QMS Monitoring Formats (e.g.,Temp & Humidity, Data Backup) Review of Audit Trails for GxP Computerized Systems Preferred candidate profile Bachelors or Master's degree in Science or related field. Professional certifications related to Quality Management Systems (QMS), ISO standards, or calibration (e.g., Six Sigma, ISO 9001 Lead Auditor) are an advantage

Handle in-process & final inspection, IMS documentation, root cause analysis, process, product &system audits, continuous quality & process improvement projects. Coordinate with production R&D & purchase to ensure quality compliance Required Candidate profile know IMS 7 QC tool CAPA FMEA &inspection instrument Strong documentation communication &team handling Mfg or eng industry background pref with hands-on qlty assurance exp Handle customer complaints