Sr. Specialist External Quality
hace 3 semanas
.Job Description Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. The Product Quality Manager (PQM) is the Sr. Specialist within External Quality responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies, and guidelines governing the External Partners (EP/ExP's) manufacture and release of Vaccine or Biologic Drug Substances and/or Drug products by means of risk-based quality oversight and on-site supervision, as appropriate. The PQM will work within the Focus Factory Team to support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity. Primary Activities may include, but are not limited to the following: Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records. Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer. Provide support for audits of EP/ExP by ourselves and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted. Conduct routine and solve complex analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly. Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements. Track and monitor operational and quality performance of the external manufacturer/partner and work with suppliers to develop CAPA plans
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Quality Assurance Specialist
hace 2 días
Zaragoza, Zaragoza, España K-LAGAN A tiempo completoQuality Assurance SpecialistWe are seeking a Quality Assurance Specialist to join our team at K-LAGAN. As a Quality Assurance Specialist, you will be responsible for developing and implementing quality control and quality assurance procedures that comply with industry standards and regulations.Key Responsibilities:Develop and implement quality control and...
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Quality Assurance Specialist
hace 1 mes
Zaragoza, Zaragoza, España K-LAGAN A tiempo completoQuality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at K-LAGAN. As a Quality Assurance Specialist, you will be responsible for developing and implementing quality control and quality assurance procedures that comply with industry standards and regulations.Key Responsibilities:Develop and implement quality...
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Quality Assurance Specialist
hace 1 mes
Zaragoza, Zaragoza, España K-LAGAN A tiempo completoQuality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at K-LAGAN. As a Quality Assurance Specialist, you will be responsible for developing and implementing quality control and quality assurance procedures that comply with industry standards and regulations.Key Responsibilities:Develop and implement quality...
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Quality Specialist
hace 1 mes
Zaragoza, España Worldwide Recruitment Solutions (Wrs) A tiempo completoQuality Specialist - MadridOn behalf of a major PMC, I am looking for a Quality Specialist to work in Rome on a contract basis. This will be a long-term contract, based residentially in Rome, paying an hourly rate in USD.The role will be supporting the development of a large Petrochemical facility, which is currently in FEED stage.Please note: You must have...
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Plant Quality Assurance Specialist
hace 1 mes
Zaragoza, Zaragoza, España K-LAGAN A tiempo completoPlant Quality Assurance SpecialistWe are an international strategic company of technological services, committed to our team and society. We offer solutions in IT services, engineering developments, electronics, and R&D projects.We are looking for a Plant Quality Assurance Specialist for our Tier 1 client located in Zaragoza.The selected person will be...
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Plant Quality Assurance Specialist
hace 1 mes
Zaragoza, Zaragoza, España K-LAGAN A tiempo completoPlant Quality Assurance SpecialistWe are an international strategic company of technological services, committed to our team and society. We offer solutions in IT services, engineering developments, electronics, and R&D projects.We are looking for a Plant Quality Assurance Specialist for our Tier 1 client located in Zaragoza.The selected person will be...
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Quality Assurance Specialist
hace 3 días
Zaragoza, Zaragoza, España Zigup Plc A tiempo completoQuality Assurance SpecialistAre you a detail-oriented individual with a passion for quality? Do you want to work in a dynamic team that values technical excellence? We're looking for a Quality Assurance Specialist to join our team at Zigup Plc.As a Quality Assurance Specialist, you will be responsible for ensuring that our vehicle repairs meet the highest...
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Sr. Specialist, Distribution And Logistics
hace 5 días
Zaragoza, España Moderna Inc A tiempo completo.Sr. Specialist, Distribution and LogisticsJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues...
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Quality Engineer
hace 4 semanas
Zaragoza, España Cummins Quality A tiempo completo.DESCRIPTIONWe are looking for a talented Quality Engineer – Senior to join our team specializing in Quality for our Powergen Office in San Fernando de Henares, Spain.This is a hybrid role, with onsite expectations in Madrid. It also requires both domestic and international travel to audit and assess supplier sites as needed.Relocation is not eligible....
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Quality Assurance Specialist
hace 2 semanas
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Title: Quality Customer SpecialistDescription:At HITACHI ENERGY SPAIN, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a...
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Quality Assurance Specialist
hace 1 semana
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Title: Quality Customer SpecialistDescription:At HITACHI ENERGY SPAIN, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a...
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Quality Assurance Specialist
hace 1 semana
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Title: Quality Customer SpecialistDescription:At HITACHI ENERGY SPAIN, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a...
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Quality Assurance Specialist
hace 2 semanas
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Title: Quality Customer SpecialistDescription:At HITACHI ENERGY SPAIN, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a...
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Sr. Credit Collection Specialist
hace 1 semana
Zaragoza, España Align Technology, Inc. A tiempo completo.Join a team that is changing millions of lives.Transforming smiles, changing lives.At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost...
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Quality Assurance Specialist
hace 3 días
Zaragoza, Zaragoza, España Oilandgas.Org A tiempo completoJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Oilandgas.Org. The successful candidate will be responsible for developing and implementing quality strategies to ensure the highest level of quality and safety in our supplier relationships.Key Responsibilities:Deploy the Vestas Quality, Safety and Environment...
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Quality Assurance Specialist
hace 3 días
Zaragoza, Zaragoza, España Welocalize A tiempo completoWelocalize OpportunityWe are seeking a skilled Quality Assurance Specialist to join our team of linguists who specialize in Linguistic Validation of Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), and Clinician Reported Outcomes (ClinRO).Key Responsibilities:Review translated files prior to client delivery to ensure accuracy and...
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Senior Quality Assurance Specialist
hace 2 días
Zaragoza, Zaragoza, España Alk Abello Spa A tiempo completoJob Title: Senior Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Alk Abello Spa. As a Senior Quality Assurance Specialist, you will be responsible for providing support and guidance on quality assurance activities, including change control, deviations, and CAPA. You will also...
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Zaragoza, Zaragoza, España Quality Enterprises Usa A tiempo completoAbout the RoleAs a Quality Specialist, you will contribute to improving and extending people's lives by supporting the qualified person during the release activities of medicinal products used in clinical trials and managed access programs.You will collect and check documentation from different databases involved in the release process, exchange with...
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Quality Customer Specialist
hace 3 semanas
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Description:At Hitachi Energy Spain, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a timely and effective...
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Quality Customer Specialist
hace 3 semanas
Zaragoza, Zaragoza, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoJob Description:At Hitachi Energy Spain, S.A.U., we are seeking a highly skilled Quality Customer Specialist to join our team. As a Quality Customer Specialist, you will play a crucial role in deploying and supporting a Quality Culture within our organization.Your Responsibilities:Manage customer complaints and feedback in a timely and effective...
