Quality Assurance Consultant
7 giorni fa
Job SummaryThe 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 ResponsibilitiesQMS 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.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.QualificationsBachelor'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).Attention to detail and accuracy.Strong organizational and time management skills.Effective leadership and team management abilities.#J-18808-Ljbffr
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Quality Assurance Consultant
7 giorni fa
Pomezia, Italia Steris Ims A tempo pienoJob 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,...
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Quality Assurance Consultant
7 giorni fa
Pomezia, Italia Steris Ims A tempo pienoJob SummaryThe 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,...
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Quality Assurance Consultant
1 settimana fa
Pomezia, Italia STERIS IMS A tempo pienoJob SummaryThe 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,...
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Quality Assurance Consultant
1 settimana fa
Pomezia, Italia STERIS IMS A tempo pienoJob 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,...
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Quality Assurance Consultant
1 settimana fa
Pomezia, Italia STERIS IMS A tempo pienoJob 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,...
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Senior GxP QA
1 settimana fa
Pomezia, Italia STERIS IMS A tempo pienoA leading pharmaceutical company seeks a Quality Assurance Consultant to implement and oversee the Quality Management System. Responsible for ensuring compliance with regulatory standards and managing quality risk, complaints, and local product release. The ideal candidate has a bachelor's degree in Quality Management or related fields and at least 5 years...
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Senior GxP QA
1 settimana fa
Pomezia, Italia STERIS IMS A tempo pienoA leading pharmaceutical company seeks a Quality Assurance Consultant to implement and oversee the Quality Management System. Responsible for ensuring compliance with regulatory standards and managing quality risk, complaints, and local product release. The ideal candidate has a bachelor's degree in Quality Management or related fields and at least 5 years...
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Senior Gxp Qa
7 giorni fa
Pomezia, Italia Steris Ims A tempo pienoA leading pharmaceutical company seeks a Quality Assurance Consultant to implement and oversee the Quality Management System.Responsible for ensuring compliance with regulatory standards and managing quality risk, complaints, and local product release.The ideal candidate has a bachelor's degree in Quality Management or related fields and at least 5 years of...
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Quality Assurance Lead
2 settimane fa
Pomezia, Italia Northrop Grumman Italia A tempo pienoSiamo un'azienda specializzata in sistemi di navigazione integrati, parte di un leader multisettoriale nel settore dell'alta tecnologia, elettronica avanzata e sistemi di difesa che opera attraverso le sue strutture in tutto il mondo. Stiamo cercando un Supplier Quality Assurance Lead che entri a far parte della nostra realtà. In questo ruolo, la risorsa si...
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Quality Assurance Lead
2 settimane fa
Pomezia, Italia Northrop Grumman Italia A tempo pienoSiamo un'azienda specializzata in sistemi di navigazione integrati, parte di un leader multisettoriale nel settore dell'alta tecnologia, elettronica avanzata e sistemi di difesa che opera attraverso le sue strutture in tutto il mondo. Stiamo cercando un Supplier Quality Assurance Lead che entri a far parte della nostra realtà. In questo ruolo, la risorsa si...
