Senior Specialist, Quality Assurance Auditor
hace 4 días
.Job DescriptionThe PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.Responsibilities:Evaluate Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements.Schedule and conduct GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.Prepare audit reports and manage follow-up activities with limited guidance.Conduct meetings with Senior Management to discuss audit observations and responses.Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan.Responsible to ensure audit tracking tools are up to date.Participate in regulatory inspections and external audits, when required.Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF).Maintain a high degree of knowledge of global industry expectations and GVP/GCP regulations.Train and mentor junior team members.Required Education, Experience, and SkillsBachelor's degree in a relevant field (Pharmacy, Life Sciences, etc.).Minimum of five (5) years of experience in the pharmaceutical industryMinimum of one (1) years of experience in GVP/GVP auditing with EU/FDA /global regulatory requirementsStrong knowledge of EMA, FDA and ICH guidelines.Attention to detail and ability to work independently.Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).Preferred Education, Experience, and SkillsFluency in written and spoken English, additional language skills a plus.Primary skills include but are not limited to:Collaboration and Partnering : Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.Communication Skills: Strong verbal skills and experienced effective writing skills.Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within R&D are compliant with regulations and appropriate procedures
-
Senior Specialist, Quality Assurance Auditor
hace 1 mes
Madrid, España Organon A tiempo completoJob DescriptionThe PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention...
-
Senior Specialist, Quality Assurance Auditor
hace 3 semanas
Madrid, España Organon A tiempo completoJob DescriptionThe PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention...
-
Senior Specialist, Quality Assurance Auditor
hace 1 semana
Madrid, Madrid, España bioM?rieux BV A tiempo completoJob Description The Position The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and...
-
Senior Clinical Trials Quality Assurance Auditor
hace 3 semanas
Madrid, España Novasyte A tiempo completoSummary: - The Work we do at IQVIA impacts lives all over the world. At IQVIA, the Largest Human Data Science Company in the world, we accelerate innovation for a healthier world. Come and join us to help our customers and partners do extraordinary things for healthcare!- The IQVIA Enterprise QA team is a dynamic, talented, and experienced global team that...
-
Quality Assurance Specialist
hace 1 semana
Madrid, Madrid, España Iqvia A tiempo completoJOB OVERVIEWThe Linguistic Solutions team within PCS Instrument Services is seeking a motivated and detail-oriented entry-level Quality Assurance Specialist.The ideal candidate will support the quality assurance of translation project deliverables of Clinical Outcomes Assessments (COAs), ensuring the highest standards of accuracy and consistency.This role...
-
Senior Clinical Trials Quality Assurance Auditor
hace 1 semana
Madrid, Madrid, España Novasyte A tiempo completoSummary: The Work we do at IQVIA impacts lives all over the world. At IQVIA, the Largest Human Data Science Company in the world, we accelerate innovation for a healthier world. Come and join us to help our customers and partners do extraordinary things for healthcare The IQVIA Enterprise QA team is a dynamic, talented, and experienced global team that owns...
-
Quality Assurance Specialist
hace 1 semana
Madrid, Madrid, España IQVIA A tiempo completoJOB OVERVIEW The Linguistic Solutions team within PCS Instrument Services is seeking a motivated and detail-oriented entry-level Quality Assurance Specialist. The ideal candidate will support the quality assurance of translation project deliverables of Clinical Outcomes Assessments (COAs), ensuring the highest standards of accuracy and consistency. This...
-
Quality Assurance Specialist
hace 1 semana
Madrid, Madrid, España IQVIA A tiempo completoJOB OVERVIEWThe Linguistic Solutions team within PCS Instrument Services is seeking a motivated and detail-oriented entry-level Quality Assurance Specialist. The ideal candidate will support the quality assurance of translation project deliverables of Clinical Outcomes Assessments (COAs), ensuring the highest standards of accuracy and consistency. This role...
-
Quality Assurance Specialist
hace 3 semanas
Madrid, Madrid, España IQVIA A tiempo completoJOB OVERVIEWThe Linguistic Solutions team within PCS Instrument Services is seeking a motivated and detail-oriented entry-level Quality Assurance Specialist. The ideal candidate will support the quality assurance of translation project deliverables of Clinical Outcomes Assessments (COAs), ensuring the highest standards of accuracy and consistency. This role...
-
Senior Principal Quality Auditor
hace 4 días
Madrid, España Precision For Medicine A tiempo completo.Senior Principal Quality Auditor (Remote) Senior Principal Quality Auditor | Precision For Medicine |SpainPrecision for Medicine is hiring a Senior/Principal QualityAuditor to join our team, candidates can be based in either UK, Spain,Hungary, Poland, Romania, Serbia or Slovakia.... Login to continue Precision for Medicine is hiring a Senior/Principal...
-
Quality Assurance Es – Tester
hace 4 semanas
Madrid, España Itrecruiter A tiempo completoQUALITY ASSURANCE ES – TESTER (REMOTE/HYBRID) QUALITY ASSURANCE – TESTER (REMOTE / HYBRID MADRID)Portuguese company hires for remote/hybrid workFLUENT ENGLISH AND SPANISH (C1/C2)DescriptionDescription: As a TV Software Quality Assurance (QA) Tester, your main responsibility will be to ensure the quality and functionality of our TV software products. This...
-
Quality Assurance Es – Tester
hace 1 semana
Madrid, Madrid, España Itrecruiter A tiempo completoQUALITY ASSURANCE ES – TESTER (REMOTE/HYBRID)QUALITY ASSURANCE – TESTER (REMOTE / HYBRID MADRID)Portuguese company hires for remote/hybrid workFLUENT ENGLISH AND SPANISH (C1/C2)DescriptionDescription: As a TV Software Quality Assurance (QA) Tester, your main responsibility will be to ensure the quality and functionality of our TV software products. This...
-
Quality Specialist
hace 3 semanas
Madrid, Madrid, España ersg A tiempo completoROLE : Quality Specialist Location : Multiple locations within the EU Start Date : Immediate Length of Contract : 6 Months Language skills : English & Spanish (Both written & speaking)Experience Needed:5 years quality Quality auditor 's experience knowledge in Quality ,Health & Safety and Environment Experience in Offshore Wind Must have full GWOs...
-
Quality Specialist
hace 1 mes
Madrid, Madrid, España ersg A tiempo completoROLE : Quality Specialist Location : Multiple locations within the EU Start Date : Immediate Length of Contract : 6 Months Language skills : English & Spanish (Both written & speaking)Experience Needed:5 years quality Quality auditor 's experience knowledge in Quality ,Health & Safety and Environment Experience in Offshore Wind Must have full GWOs...
-
Quality Assurance
hace 4 semanas
Madrid, España Inverge Studios A tiempo completoProject Ava is a new indie IP published by 11bit studios ( This War of Mine, Frostpunk ) and developed by Inverge Studios ( Effie ). We're looking for a Quality Assurance role to join our small team, in order to improve and give a quality boost to the game. This is a full-time, on-site position at our offices in Valencia.What our Quality Assurance do Play...
-
Quality Assurance
hace 4 semanas
Madrid, España Inverge Studios A tiempo completoProject Ava is a new indie IP published by 11bit studios ( This War of Mine, Frostpunk ) and developed by Inverge Studios ( Effie ). We're looking for a Quality Assurance role to join our small team, in order to improve and give a quality boost to the game. This is a full-time, on-site position at our offices in Valencia.What our Quality Assurance do Play...
-
Quality Assurance
hace 1 semana
Madrid, Madrid, España Inverge Studios A tiempo completoProject Ava is a new indie IP published by 11bit studios ( This War of Mine, Frostpunk ) and developed by Inverge Studios ( Effie ). We're looking for a Quality Assurance role to join our small team, in order to improve and give a quality boost to the game. This is a full-time, on-site position at our offices in Valencia.What our Quality Assurance do Play...
-
Quality Assurance Manager
hace 2 meses
Madrid, España NonStop Consulting A tiempo completoAre you a skilled Quality Assurance professional looking to make a significant impact in the pharmaceutical industry? Our client, a leading CRO specializing in clinical research nationally and internationally, is seeking a talented individual to join their team as a Quality Assurance Manager. You will have the opportunity to play a crucial role in...
-
Quality Assurance Es – Tester
hace 1 semana
Madrid, Madrid, España Itrecruiter A tiempo completoQUALITY ASSURANCE TESTER (REMOTE / HYBRID MADRID)Portuguese company hires for remote / hybrid workFLUENT ENGLISH AND SPANISH (C1 / C2)DescriptionDescription : As a TV Software Quality Assurance (QA) Tester, your main responsibility will be to ensure the quality and functionality of our TV software products.This will primarily involve conducting manual...
-
Quality Assurance Specialist
hace 4 días
Madrid, España Galderma A tiempo completoGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...
