Quality Assurance Consultant
3 weeks ago
Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.Key Responsibilities:QMS implementation, maintenance, and oversight in local affiliates.Maintenance of the local Quality Manual and Site Master File.Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.Change control management, QA assessment, site change control, QA review for change implementation and closure.Deviation management for internal, external, and transport deviations.CAPA management from deviations, internal audits, external audits, and self-inspections.Management of authority inspections and self-inspections.Local GxP surveillance and assessment.Product quality review (PQR).Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.Oversight of GDP requirements for local warehousing and distribution.Shipping lane qualification and local transport performance of secondary distribution.Secondary distribution transport performance review.Return management, including QA evaluation against return criteria and collaboration with distributors.Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.Qualifications:Bachelor's degree in Quality Management, Life Sciences, or a related field.Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.Strong knowledge of GxP regulations and quality standards.Excellent analytical, problem-solving, and communication skills.Ability to work independently and collaboratively in a team environment.Proficiency in using Quality Management Systems and Learning Management Systems (LMS).Key Competencies:Attention to detail and accuracy.Strong organizational and time management skills.Effective leadership and team management abilities.Proactive and results-oriented mindset. #J-18808-Ljbffr
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Quality Assurance Manager
5 days ago
Bodens Kommun, Sweden Kintec Global Recruitment Full timeJob Title: QC Construction Manager (Site Quality Manager)Client: Multi-national corporation which provides consulting, engineering, and architecture services InternationallyAssignment Type: Annually Renewable ContractLocation: Boden, SwedenResidential/ Rotation: 4 weeks on site, one week working on remote, on rotation. Working 5 days per week, 8 hours per...
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Quality Assurance Manager
1 week ago
Bodens Kommun, Sweden Digisourced. Full timeRole Description: Quality Manager:Act as a key enabler within the quality organization to support definition, implementation and improvement of the quality processes and activities in all phases and areas of the construction project.Working alongside the quality control manager, preservation engineer, and area quality Managers, this role ensures alignment,...
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Supplier Quality Assurance
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Finspångs Kommun, Sweden Jefferson Wells Sverige Full time 450,500 - 600,500 per yearVill du arbeta med leverantörskvalitet i en internationell miljö och bidra till hållbara energilösningar? Vi söker en Supplier Quality Assurance Professional till ett spännande uppdrag hos Siemens Energy. Du blir en nyckelperson i att säkerställa hög kvalitet i leverantörskedjan och driva förbättringsarbete.Dina ansvarsområdenKoordinera och...
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Supplier Quality Assurance
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Finspångs Kommun, Sweden Unik Resurs i Sverige AB Full time 600,000 - 800,000 per yearFöretagspresentationTill vår kund Siemens Energy, en ledande global aktör inom energibranschen, söker vi nu en Supplier Quality Assurance för ett uppdrag på deras site i Finspång.Företaget är tack vare högteknologisk och innovativ produktutveckling en etablerad partner inom energisektorn som levererar avancerade samt hållbara lösningar för...
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Quality Assurance Manager, Bjuv
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Bjuvs Kommun, Sweden Logent Full time 600,000 - 800,000 per yearOm tjänstenI denna roll blir din absolut viktigaste arbetsuppgift blir att kontrollera att produkter och processer håller högsta möjliga standard. Du får en nyckelroll gällande att driva och utveckla företagets kvalitet- och produktutvecklingsarbete, både strategiskt och operativt. Huvudsakliga arbetsuppgifter somQuality Assurance Manager:Underhålla...
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Project Assurance Auditor
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Norrtälje Kommun, Sweden CO-WORKER TECHNOLOGY Full time 550,000 - 850,000 per yearJob details:The Project Assurance Auditor is a key member of the Quality Team, responsible for the definition, maintenance and delivery of the project assurance plan. This role ensures that the project adheres to the standards, regulatory requirements, and industry best practices; as well as that the risks are identified and mitigated by the implemented...
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Quality Assurance Manager, Bjuv
2 weeks ago
Bjuvs Kommun, Sweden Logent Full time 450,000 - 650,000 per yearOm tjänstenI denna roll blir din absolut viktigaste arbetsuppgift blir att kontrollera att produkter och processer håller högsta möjliga standard. Du får en nyckelroll gällande att driva och utveckla företagets kvalitet- och produktutvecklingsarbete, både strategiskt och operativt. Huvudsakliga arbetsuppgifter som Quality Assurance...
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Principal Quality Operations Specialist
21 hours ago
Bodens Kommun, Sweden Lutech Resources Full timeDescriptionJob Overview:The Principal Quality Operations Specialist interprets internal or external business issues and recommends best practices. They may be tasked with solving complex operations-related problems and will work independently with minimal guidance. The Principal Quality Operations Specialist may be responsible for leading functional teams or...
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Lead Site Quality Team
2 weeks ago
Bodens Kommun, Sweden Eccoci AB Full time 90,000 - 120,000 per yearWe are looking for a Lead for our Site Quality Team, responsible for overseeing all quality assurance and control activities on site. In this role, you will ensure that EPC contractors and vendors comply with project standards, specifications, and contractual requirements.You will review and supervise contractors' reports and daily activities, identify...
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Quality Inspector
1 week ago
Finspångs Kommun, Sweden Jefferson Wells Sverige Full time 60,000 - 120,000 per yearLocation Finspång, Sweden (with travel across Sweden and Europe) Company Siemens EnergyAbout The TeamOur Oil & Gas and Complex Projects Quality team ensures compliance with quality requirements from proposal stage through execution and final handover to clients. We manage project quality, inspection activities, and coordinate with classification societies....