6082 Qms Jobs - Page 50

Role & responsibilities : Production Manager and Upkeeping of QMS & EMS Preferred candidate profile : Degree/Diploma in Mechnical Engineering and experience as Management Representative for QMS & EMS Work experience: 5 - 10 Years

Role & responsibilities : Production Manager and Upkeeping of QMS & EMS Preferred candidate profile : Degree/Diploma in Mechnical Engineering and experience as Management Representative for QMS & EMS Work experience: 5 - 10 Years

What you will do In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current...

What you will do In this vital role you will The Sr. Associate QA position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain. Responsibilities : Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant sta...

HOW MIGHT YOU DEFY IMAGINATION Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a cr...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is...

JOB Description: Designation/Role: Assistant Manager IP DRG Department: Coding - Quality Reporting to: Director - Quality Location of work: Hyderabad Eligibility : For AM : candidates should have Experience TL for 2 years. Competency & Knowledge Requirements: Experience: Minimum 6 years in Medical Coding, specifically in Inpatient coding and Medical Coding business. Technical Knowledge: Strong expertise in ICD-10, CPT coding guidelines, and techniques. In-depth knowledge of Anatomy & Physiology, Advanced Medical Terminology, Psychology, and Pharmacology. Tools: Proficient in MS Office. Soft Skills: Excellent communication and interpersonal skills. Key Responsibilities: Lead and manage a team...

Must to have exp. in QA documents related to QMS, BMR, ECR, Specification, MOA, TDS, formats & SOPs controlled copy. distribution of SOPs. Handling of Change Control Systems, out of specification, deviations etc. Required Candidate profile Candidate must be from API / Chemical Industry only

The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...

So what does a Quality Manager really do? Think of yourself as a champion for operational excellence. You will closely monitor program metrics, provide insights and analysis, offer recommendations, and help manage the implementation of service and process improvement programs and efforts. Your contribution will help ensure program metrics and service level requirements for quality are met consistently. You will also take the lead in conducting quality audits, report on findings, and propose new systems and policies for continuous improvement. Consider yourself a consultant to stakeholders, a mentor and guide to Teams, and an important asset to our passionate pursuit for quality . Imagine you...

So what does a Quality Manager really do? Think of yourself as a champion for operational excellence. You will closely monitor program metrics, provide insights and analysis, offer recommendations, and help manage the implementation of service and process improvement programs and efforts. Your contribution will help ensure program metrics and service level requirements for quality are met consistently. You will also take the lead in conducting quality audits, report on findings, and propose new systems and policies for continuous improvement. Consider yourself a consultant to stakeholders, a mentor and guide to Teams, and an important asset to our passionate pursuit for quality . Imagine you...

We are seeking a highly motivated and experienced Senior Manager, Digital Solutions Engineering to join our team. The ideal candidate will have a strong background in Technology, Operations and possess exceptional skills in facilitating and overseeing product demos, ensuring successful roll-out and adoption, gathering feedback, and driving overall customer success. As a Senior Manager, you will support the Sales and Customer Service Team organization in crafting compelling technology solutions for our clients. She/he will have a good understanding of all the technical pieces (software and hardware) that fit in the BPO/Contact Center industry. Key Responsibilities: Provide Technical and Consu...

We are seeking a highly motivated and experienced Senior Manager, Digital Solutions Engineering to join our team. The ideal candidate will have a strong background in Technology, Operations and possess exceptional skills in facilitating and overseeing product demos, ensuring successful roll-out and adoption, gathering feedback, and driving overall customer success. As a Senior Manager, you will support the Sales and Customer Service Team organization in crafting compelling technology solutions for our clients. She/he will have a good understanding of all the technical pieces (software and hardware) that fit in the BPO/Contact Center industry. Key Responsibilities: Provide Technical and Consu...

We are seeking a highly motivated and experienced Senior Manager, Digital Solutions Engineering to join our team. The ideal candidate will have a strong background in Technology, Operations and possess exceptional skills in facilitating and overseeing product demos, ensuring successful roll-out and adoption, gathering feedback, and driving overall customer success. As a Senior Manager, you will support the Sales and Customer Service Team organization in crafting compelling technology solutions for our clients. She/he will have a good understanding of all the technical pieces (software and hardware) that fit in the BPO/Contact Center industry. Key Responsibilities: Provide Technical and Consu...

We are seeking a highly motivated and experienced Senior Manager, Digital Solutions Engineering to join our team. The ideal candidate will have a strong background in Technology, Operations and possess exceptional skills in facilitating and overseeing product demos, ensuring successful roll-out and adoption, gathering feedback, and driving overall customer success. As a Senior Manager, you will support the Sales and Customer Service Team organization in crafting compelling technology solutions for our clients. She/he will have a good understanding of all the technical pieces (software and hardware) that fit in the BPO/Contact Center industry. Key Responsibilities: Provide Technical and Consu...

We are seeking a highly motivated and experienced Senior Manager, Digital Solutions Engineering to join our team. The ideal candidate will have a strong background in Technology, Operations and possess exceptional skills in facilitating and overseeing product demos, ensuring successful roll-out and adoption, gathering feedback, and driving overall customer success. As a Senior Manager, you will support the Sales and Customer Service Team organization in crafting compelling technology solutions for our clients. She/he will have a good understanding of all the technical pieces (software and hardware) that fit in the BPO/Contact Center industry. Key Responsibilities: Provide Technical and Consu...

Key Responsibilities: Supervise and coordinate quality control activities during production. Inspect raw materials, in-process production, and finished goods for compliance with quality standards. Ensure adherence to company quality policies, procedures, and safety regulations. Train and guide quality control staff on inspection techniques and quality standards. Identify defects and non-conformities; recommend corrective actions. Maintain and update quality records, inspection reports, and documentation. Collaborate with production, engineering, and supply chain teams to resolve quality issues. Conduct root cause analysis and support continuous improvement initiatives. Monitor quality metric...

Key Responsibilities: Supervise and coordinate quality control activities during production. Inspect raw materials, in-process production, and finished goods for compliance with quality standards. Ensure adherence to company quality policies, procedures, and safety regulations. Train and guide quality control staff on inspection techniques and quality standards. Identify defects and non-conformities; recommend corrective actions. Maintain and update quality records, inspection reports, and documentation. Collaborate with production, engineering, and supply chain teams to resolve quality issues. Conduct root cause analysis and support continuous improvement initiatives. Monitor quality metric...

Role & responsibilities 1.Candidate should be core mechanical(B.tech, Diploma). 2.Person should have hands on experience in troubleshooting of vial washing machine. 3.Person should have hands on experience in troubleshooting of Depyrogenating tunnel. 4.Person should have hands on experience in troubleshooting of Filling machine. 5.Person should have hands on experience in troubleshooting of vial capping/sealing machine. 6.Person should have hands on experience in troubleshooting of sterilization autoclave. 7. Person should have hands on experience in troubleshooting of Formulation and Filtration vessels. 8. Person should be capable of attending the breakdowns on time and closing the same. 9....

The Director - corporate Quality will be responsible for designing, implementing, and overseeing the organization's Quality, Security, and Compliance programs. This role demands expertise in managing ISMS, QMS, HITRUST, SOC, PCI-DSS, and BCMS frameworks. The incumbent will lead internal audits, interface with external auditing bodies, ensure regulatory compliance, and maintain client trust through proactive governance and communication. KEY RESPONSIBILITIES Develop, maintain, and improve QMS and ISMS frameworks in alignment with industry standards (ISO 9001, ISO 27001, PCI-DSS, SOC, and BCMS) Expertise in managing the HITRUST certification Ensure compliance with security and quality requirem...

Develop Quality Standards Implement & Monitor Quality Systems Conduct Audits & Inspections: Lead & Manage Teams Data Analysis & Reporting Process Improvement Customer Engagement Compliance

The QA/QC Lead Auditor conducts internal and supplier audits to ensure compliance with ISO/GMP standards, identifies quality gaps, drives corrective actions, and supports continuous improvement in quality systems. Required Candidate profile Conduct internal & supplier audits, ensure ISO/GMP compliance, prepare reports, track CAPA, support certifications, and drive continuous improvement in quality systems. ISO 9001, ISO 13485, GMP pref.

SUMMARY Associate - Business Systems Ahmedabad, INDIA I Position Code: 1201XA About the Role: We are looking for an Associate - Business Systems, who thrives in a high performance and fast paced technical environment. As an Associate within the Business Systems team, you will be responsible for independently performing most function tasks, ensuring that our customer receives a great product. What you'll deliver: Work to team plan & deliver your tasks on-time & within budget Evaluate your work progress to the plan and make required course corrections Develop & Implement 'real-time audit ready QMS' as per AS9100, Nadcap and customer specific standards Effective implementation of lean manufactu...

SUMMARY Associate - Business Systems Ahmedabad, INDIA I Position Code: 1201XA About the Role: We are looking for an Associate - Business Systems, who thrives in a high performance and fast paced technical environment. As an Associate within the Business Systems team, you will be responsible for independently performing most function tasks, ensuring that our customer receives a great product. What you'll deliver: Work to team plan & deliver your tasks on-time & within budget Evaluate your work progress to the plan and make required course corrections Develop & Implement 'real-time audit ready QMS' as per AS9100, Nadcap and customer specific standards Effective implementation of lean manufactu...

Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgens Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issu...