GMP Compliance Expert in QA
vor 1 Tag
TN Switzerland is a global leader in life sciences with a strong commitment to innovation and collaboration. We are seeking a dedicated Senior Quality Assurance Specialist for Analytics to join our team.
In this role, you will work closely with our Quality Control and Analytical Development departments to ensure the quality of GMP-relevant activities. This includes reviewing and approving SOPs, analytical methods/specifications, and validation plans/reports to ensure compliance with our standards, customer requirements, and health authority expectations.
You will also be responsible for representing QA concerns and ensuring cGMP requirements are met. Key responsibilities include:
- Representing QA concerns to the Quality Control department and ensuring cGMP requirements are followed.
- Controlling and releasing GMP relevant documents of the QC department.
- Reviewing and approving SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports issued by the QC/AD departments.
- QA supervision for OOX events during investigation in QC/AD: Reviewing and approving Out-of-Specifications/-Expectations/-Trend results.
- Writing or revising SOPs in the area of expertise and ownership of these documents.
- Ensuring compliance with cGMP in the areas of stability testing and reference standards.
- Cooperating, reviewing, and approving deviations (DRs), investigations (INV), changes (CRs), and CAPAs within analytics (QC).
- Participating in customer audits and inspections.
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GMP Compliance Manager
Vor 2 Tagen
Visp, Schweiz Cpl Healthcare VollzeitAbout the PositionWe are seeking an experienced expert to lead our cleaning operations and ensure compliance with GMP standards in a mammalian manufacturing facility.This role requires a strong understanding of manufacturing operations, quality compliance, and cleaning validation. The ideal candidate will have experience in Manufacturing Specialist or...
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GMP Compliance Expert
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Visp, Schweiz EPM Scientific - Phaidon International VollzeitAbout the RoleThis is an exciting opportunity to join our EPM Scientific - Phaidon International team as a Thermal Validation Subject Matter Expert.You will be working in a GMP-compliant bio-technology environment, ensuring the qualification and validation of process and support equipment.Responsibilities:Validation of process and support equipment,...
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QA Expert – Utility Systems
Vor 3 Tagen
Visp, Schweiz TN Switzerland VollzeitTN Switzerland is dedicated to finding talented individuals who share our passion for improving lives through innovative solutions in life sciences.Role Summary:This QA expert will be responsible for providing Quality Assurance oversight to the company's sites and facilities, ensuring that shared utility systems and logistics areas are carried out by the...
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GMP Specialist Lead
vor 1 Tag
Visp, Schweiz BioTalent Ltd VollzeitWe are seeking a GMP Specialist Lead to oversee the implementation of quality systems and ensure compliance with regulatory requirements. This includes adhering to ISO/cGMP standards, PIC/S GMP (part 1-2) or EU Guidelines (Annex 1).The successful candidate will have 5-10 years of QA experience in commercial drug substance/product or aseptic processing,...
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QA-Spezialist für GMP-Produkte
Vor 3 Tagen
Visp, Schweiz Lonza VollzeitZielsetzungUnser Ziel besteht darin, eine optimale Qualität unserer Produkte zu gewährleisten und so unsere Kunden zufriedenzustellen.ArbeitsaufgabenAls QA-Spezialist sind Sie verantwortlich für die Durchführung von Qualitätskontrollen und -tests our Herstellungsprozesse, sowie die Prüfung und Freigabe von Produkten.Ihre Hauptaufgaben...
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GMP Compliance Officer
vor 8 Stunden
Visp, Schweiz Lonza VollzeitJob Description:About the Role:The successful candidate will develop and implement a training strategy and roadmap for the site, aligning with BioAtrium QA GMP Training Manager, local and global strategy and roadmap.Develop effective training programsTrain and qualify other trainersSupport technical and GMP trainingLiaise with operations teamSupport...
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GMP Compliance Trainer
vor 1 Tag
Visp, Schweiz TN Switzerland VollzeitKey ResponsibilitiesThe GMP Compliance Trainer will be responsible for ensuring that our production operations comply with Good Manufacturing Practice (GMP) regulations. You will achieve this by assessing training needs, designing and implementing comprehensive training concepts, and ensuring regulatory compliance.In addition, you will evaluate the...
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Hybrid QA Lead
Vor 3 Tagen
Visp, Schweiz TN Switzerland VollzeitTN Switzerland is committed to hiring top talent who can contribute to the company's mission of improving lives through innovative solutions in life sciences.Job Details:This Hybrid QA Lead will be responsible for providing Quality Assurance oversight to the company's sites and facilities, ensuring that shared utility systems and logistics areas are carried...
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GMP-Experte für Reinigung und Analyse
Vor 3 Tagen
Visp, Schweiz Lonza VollzeitUnser Unternehmen Lonza ist ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeiter, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeiter ihre Karriere...
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GMP Compliance Specialist
Vor 2 Tagen
Visp, Schweiz TN Switzerland VollzeitSenior QA Specialist Role SummaryTN Switzerland is seeking a Senior Quality Assurance Specialist to join its team in Visp. In this role, you will oversee quality assurance activities related to raw materials and collaborate with interdisciplinary teams to ensure product quality throughout the manufacturing process.ResponsibilitiesMaintain quality standards...
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Operations Cleaning Expert
Vor 2 Tagen
Visp, Schweiz Cpl Healthcare VollzeitAbout the RoleWe are seeking a seasoned expert to oversee and optimize GMP-compliant cleaning operations in a mammalian manufacturing facility.This role requires a strong understanding of manufacturing operations, quality compliance, and cleaning validation. The ideal candidate will have experience in Manufacturing Specialist or Bioprocess Engineer roles...
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Regulatory Compliance Specialist
Vor 3 Tagen
Visp, Schweiz TN Switzerland VollzeitTN Switzerland is looking for a highly skilled Regulatory Compliance Specialist to join our QA Projects and Change Controls group in BioAtrium. The successful candidate will support QMS GMP compliance, promote adherence and continuous improvement of Quality Systems, and ensure Quality oversight in the specified area.Responsibilities:Own quality records such...
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Quality Systems Compliance Officer
vor 1 Tag
Visp, Schweiz BioTalent Ltd VollzeitBioTalent Ltd is hiring a Quality Systems Compliance Officer to guarantee adherence to regulatory requirements. This includes ensuring compliance with ISO/cGMP standards, PIC/S GMP (part 1-2) or EU Guidelines (Annex 1).The role involves providing oversight, making independent quality decisions, and overseeing audits, validation, change controls, CAPAs, and...
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QA PL Drug Product Expert
Vor 7 Tagen
Visp, Schweiz Experis Switzerland VollzeitJoin Experis Switzerland as a QA PL Drug Product Expert and take on a challenging role in our team in Visp.Role OverviewThe selected candidate will be responsible for supervising compliance and customer quality agreements (QAA) activities for Drug Product Visp, establishing and negotiating quality agreements (QAA) with external partners, and acting as point...
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Prozessspezialist in der GMP Produktion
Vor 4 Tagen
Visp, Schweiz Lonza Biologics Porriño SLU VollzeitUnser Ziel ist es, die Qualität unserer Herstellungsprozesse kontinuierlich zu verbessern. Dazu gehört auch die Schulung und Weiterbildung unserer Mitarbeitenden. Sie werden Teil unseres QA Operations Teams sein und eng mit verschiedenen Qualitäts- und Betriebsfunktionen zusammenarbeiten, um die Sicherstellung von cGMP-konformen Herstellungsaktivitäten...
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Quality Systems Compliance Expert
vor 8 Stunden
Visp, Schweiz Actalent VollzeitKey ResponsibilitiesAs a Senior Quality Systems Manager at Actalent, you will be responsible for:Ensuring adherence to ISO/cGMP quality system requirements.Providing expert guidance to operations and quality control staff on compliance matters.Making informed quality-related decisions leveraging regulatory and compliance expertise.Evaluating and improving...
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QA Project Leader for Drug Product
vor 1 Woche
Visp, Schweiz Proclinical Group VollzeitProclinical is seeking a dedicated QA Project Leader to oversee compliance and customer quality agreement activities for drug products. This role involves establishing and negotiating quality agreements, acting as a point of contact for QA-related inquiries, and supporting manufacturing operations. The successful candidate will play a crucial role in...
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QA Analytics Specialist
vor 1 Tag
Visp, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Hybrid Working Model (3 days in the office, 2 days WFH)Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to...
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QA PL Drug Product
vor 1 Woche
Visp, Schweiz Real Staffing VollzeitSales Consultant at Real Staffing - SThreeQA PL Drug Product SpecialistDuration: 8 months initialTasks:Supervise compliance and customer Quality Agreement (QAA) activities for Drug Product Visp.Establish and negotiate QAAs with Drug Product Services (DPS) and Drug Substance (DS) sites.Address QA-related questions, topics, and complaints from customers.Manage...
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Manufacturing Operations Cleaning Expert
vor 4 Wochen
Visp, Schweiz Experis Switzerland VollzeitManufacturing Operations Cleaning Expert (BBBH609525) Visp, SwitzerlandDescription:This position focuses on overseeing and optimizing cleaning operations in a GMP-compliant manufacturing environment, particularly within a mammalian asset that is in its startup phase. The expert will be responsible for managing the cleaning processes, ensuring regulatory...