Quality Assurance Coordinator
hace 1 mes
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.The purpose of the role is to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions.In support of this mission, the purpose of this role within an Affiliate/Region is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The role will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements. Provide updates on internal/external GxP trends and changes through the country/regional affiliate leadership team(s). Acting as a contact person regarding quality and business process compliance concerns between affiliates and global.ResponsibilitiesImplement and Manage Quality SystemsContribute to the development and review of country/region specific quality system documents to ensure requirements and accountabilities are represented.Approve regional and/or local required tools, resources, forms, templates.Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates.Recommend new procedures or changes to existing procedures where applicable.Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).Support activities and processes related to external party management (such as, third-party organizations, business alliance partners) as assigned.Perform quality self-assessments, as needed.Provide Quality Oversight for business area(s)Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).Communicates and escalates compliance issues to management locally and globally, as appropriate.Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions and provide updates to business and quality leadership.Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.Monitor completion of quality related required actions such as: CAPA associated with deviations, change controls, audit or inspection commitments.Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.Share key learning to drive simplification and replicate best practices in the region and globally.Coordinate quality improvement initiatives.Seek and implement simplification and process improvement.Audits and InspectionsFacilitate audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).Manage audit and/or inspection responses.Communicate and ensure inspection readiness requirements are in place, being organization and availability of documents such as training records, job description, backroom and/or front room organization.Ensure completion of audit or inspection CAPA plans and timely resolution.Partnership with other area(s)Functions as the initial point of consultation for business areas on quality related questions.Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.Shares key learning to drive simplification and replicate best practices.Collaborates with other quality groups as appropriate and develops quality network.Establishes good working relationships with assigned business area(s).Actively participates in team, business and quality related meetings.Utilize a risk-based approach in guiding business areas.Support key projects as assigned.Other responsibilitiesUnderstand the handling of confidential information (patient privacy, confidential audits and regulatory inspections).Understand the role and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV) and as applicable, any locally required pharmacovigilance qualified person role.Minimum Qualification Requirements:Bachelor’s or Master’s degree in health sciences.Three years experience in quality and/or drug product safety/regulatory.Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (such as GMP, GCP, GVP).Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies.Demonstrated ability to communicate effectively, both written and verbal, and to influence others.Demonstrated ability to prioritise and handle multiple concurrent tasks.Demonstrated ability to apply risk-based decision making in a regulated environment.Other Information/Additional PreferencesDemonstrated ability to work in a global environment.Ability to travel.Cultural sensitivity.
#J-18808-Ljbffr
-
Quality Assurance Engineeer
hace 2 semanas
España buscojobs España A tiempo completoHoltec Europe is seeking an experienced professional with project engineer expertise to support the growth of the company’s core business in the energy industry, specifically in Quality Assurance Engineering. S / he will be responsible for helping to shape and manage the development and deployment of the SMR quality assurance arrangements, processes, and...
-
Quality Assurance Engineeer
hace 1 mes
España Holtec International A tiempo completoHoltec Europe is seeking an experienced professional with project engineer expertise to support the growth of the company’s core business in the energy industry, specifically in Quality Assurance Engineering. S/he will be responsible for helping to shape and manage the development and deployment of the SMR quality assurance arrangements, processes, and...
-
Quality Assurance Specialist
hace 5 días
España Amentum A tiempo completoThis position is not currently funded and is contingent upon funding to Amentum. At this time, Amentum is seeking candidates to fulfill contingent roles. The expected award timeframe is Fall 2025.We are seeking a highly skilled Quality Assurance Specialist (QAS) to oversee and ensure the quality and compliance of government contractor performance in Rota,...
-
Quality Assurance Specialist
hace 1 mes
España Merck Gruppe - MSD Sharp & Dohme A tiempo completoJob DescriptionJoin our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute...
-
Quality Assurance Analyst
hace 1 mes
España Pepsi-Cola Products Philippines, Inc. (PCPPI) A tiempo completoWHAT YOU WILL DO The Quality Assurance Analyst will assist the Quality Assurance Manager in managing the Quality Assurance operations through the effective execution of manufacturing standards and procedures at the set frequency. Quality Management - Ensure adherence to quality standards and product quality through physical, analytical, and microbiological...
-
Quality Assurance
hace 4 semanas
España Fagron GmbH & CO. KG A tiempo completoOver de functieCarry out specifically defined activities in terms of quality guarantees and/or quality assurance systems with the aim of contributing to the optimisation of quality within the organisation.Key Responsibility tasks:Releases and conformity of batches of raw materials.Review and drafting of documentation (internal protocols, change controls,...
-
Quality Assurance
hace 1 mes
España Fagron A tiempo completoOver de functieCarry out specifically defined activities in terms of quality guarantees and/or quality assurance systems with the aim of contributing to the optimisation of quality within the organisation.Key Responsibility tasks:* Releases and conformity of batches of raw materials.* Review and drafting of documentation (internal protocols, change controls,...
-
Quality Assurance Specialist
hace 1 mes
España nucleoo A tiempo completoAbout this position: Nucleoo is looking for a talented test engineer to join us. Ready to elevate your career? We are looking for an entrepreneurial and proactive problem solver to join our Quality Assurance team! As a QA Tester, you will play a pivotal role in ensuring the quality, reliability, and performance of our software products. Requirements: -...
-
Quality Assurance
hace 3 semanas
España Fagron GmbH & CO. KG A tiempo completoOver de functieCarry out specifically defined activities in terms of quality guarantees and/or quality assurance systems with the aim of contributing to the optimisation of quality within the organisation.Key Responsibility tasks:• Releases and conformity of batches of raw materials.• Review and drafting of documentation (internal protocols, change...
-
Quality Assurance
hace 1 mes
España Fagron A tiempo completoWho we are Fagron is the world's leading pharmaceutical compounding company and offers prescribers the broadest possible range of therapeutic options. We are committed to improving the lives of millions of people across the world by developing unique concepts and innovative solutions to meet the growing global demand for customized medication. We focus on...
-
Quality Assurance Specialist
hace 1 mes
España BioSystems A tiempo completoQuality Assurance Specialist - Computer Systems ValidationDo you want to join a global biotechnology company? In BioSystems, we design, develop, produce, and market analytical solutions for five biotechnological areas:Clinical AnalysisVeterinary AnalysisFood & Beverage AnalysisAgricultural AnalysisBioprocesses AnalysisWe look for a person with customer...
-
Quality Assurance Analyst
hace 1 mes
España NN Group A tiempo completoNationale Nederlanden Individual Protection Solutions S.L is a subsidiary company of Nationale Nederlanden Group located in Madrid, Spain. We provide specialized services for the development and maintenance of insurance products for the different international Business Units from NN Group. On this occasion, we offer an indefinite Quality Assurance Analyst...
-
Quality Assurance Specialist
hace 2 semanas
España SoftBank Investment Advisers (SBIA) A tiempo completoAbout TravelPerkTravelPerk is a hyper-growth SaaS business travel platform and a pioneer in the future of business travel. It’s all-in-one platform gives travellers the freedom they want whilst providing companies with the control they need. The result saves time, money, and hassle for everyone.About TravelPerkTravelPerk is a hyper-growth SaaS business...
-
Quality Assurance Specialist
hace 4 semanas
España Softbank Investment advisers A tiempo completoAbout TravelPerkTravelPerk is a hyper-growth SaaS business travel platform and a pioneer in the future of business travel. It’s all-in-one platform gives travellers the freedom they want whilst providing companies with the control they need. The result saves time, money, and hassle for everyone.Job DescriptionThe Vendor Management Office team is looking...
-
Quality Assurance Specialist
hace 4 semanas
España Softbank Investment advisers A tiempo completoAbout TravelPerkTravelPerk is a hyper-growth SaaS business travel platform and a pioneer in the future of business travel. It’s all-in-one platform gives travellers the freedom they want whilst providing companies with the control they need. The result saves time, money, and hassle for everyone.Job DescriptionThe Vendor Management Office team is looking...
-
TÈcnic/a de Quality Assurance
hace 2 semanas
España Marlex A tiempo completoDes de Marlex Human Capital estem col-laborant amb una empresa multinacional del sector químic situada a la Garrotxa que actualment està en cerca d’un/a Tècnic/a de Quality Assurance. **¿Quina seria la teva missió a l'empresa?** En dependència de la direcció de la planta, la persona seleccionada s'encarregarà de dur a terme les següents tasques...
-
Quality Control Quality Assurance Officer
hace 1 mes
España Ferrer Internacional SA A tiempo completoEn Ferrer utilizamos nuestro negocio para luchar por la justicia social. Somos una compañía que lleva años buscando hacer las cosas de manera diferente; en lugar de maximizar el retorno de los accionistas, devolvemos gran parte de nuestros beneficios a la sociedad y los destinamos allí donde verdaderamente hacen falta. Vamos más allá del cumplimiento y...
-
Quality Assurance Specialist
hace 1 mes
España TravelPerk A tiempo completoAbout Us We're TravelPerk, a hyper-growth SaaS platform offering companies a one-stop-shop for booking, managing and reporting business travel. We've revolutionized the business travel market by offering an unrivaled selection of travel options, a powerful booking and management platform, and 24/7 customer support. It's why we've become the leading...
-
Quality Assurance
hace 1 semana
España buscojobs España A tiempo completoMerlin Digital Partner: Your Strategic Talent Partner in the Digital EcosystemAt Merlin, we are a leading talent acquisition consultancy with over 20 years of experience in the digital world. We proudly support startups, scaleups, and corporates in more than 10 countries, helping them find the talent they need to thrive across 15+ areas of...
-
Trainee Quality Assurance
hace 4 semanas
España Kymos A tiempo completoActualmente, la compañía se encuentra en búsqueda de un Trainee para el departamento de Quality Assurance. Las principales funciones de la posición serán: - Planificar y realizar auditorías e inspecciones de estudios, instalaciones y procesos para verificar el cumplimiento de los principios de las GMP en los departamentos de análisis de Kymos, S.L -...
