Sterility Assurance Expert
2 settimane fa
Role OverviewThe Sterility Assurance Expert is responsible for ensuring full compliance of aseptic and sterility processes with international regulatory standards (EU GMP, Annex 1, FDA, EMA) and company procedures, while actively contributing to the development and maintenance of a robust Contamination Control Strategy.This position serves as a technical point of reference for all sterility assurance activities, with a strong focus on biological manufacturing processes, sterile facilities, and critical support systems.Key ResponsibilitiesEnsure the correct implementation, maintenance, and continuous improvement of the Site Sterility Assurance Program.Support and oversee aseptic processing activities (dry heat and filtration) and APS within sterile manufacturing departments.Collaborate with Production, Engineering&Maintenance, MS&T, Validation and Quality Assurance teams to analyze and mitigate microbiological contamination risks, defining technical standards for sterile operations, design, qualification and validation activities.Draft, review, and approve SOPs, protocols, reports, CAPAs, and change controls related to sterility and aseptic processes.Support deviation management, root cause analysis and CAPA definition for microbiological events.Define and monitor the Contamination Control Strategy (CCS) and ensure its proper application and periodic review.Act as subject matter expert during inspections and audits (regulatory authorities, clients, corporate) for sterility assurance topics.Provide training and mentoring to operational and QA / QC personnel on asepsis, sterility, and sterile area behavior.Deliver technical guidance and coaching to the Sterility Assurance team.Support technology transfer, qualification/validation, and continuous improvement projects in the sterile manufacturing area.Ensure alignment with Corporate guidelines, international best practices and relevant regulatory updates.Manage technical interactions with clients on all sterility assurance aspects, supporting audits, technical meetings, and scientific or quality discussions.Minimum RequirementsMaster's degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, or related fields).At least 5-10 years of experience in Sterility Assurance, Microbiology, or Quality Operations within sterile or biological pharmaceutical environments.In-depth knowledge of GMP, EU GMP Annex 1 (revised), and FDA/EMA guidelines.Hands-on experience with APS, aseptic processing, and environmental monitoring.Familiarity with electronic quality systems (TrackWise, Veeva, SAP-QM, or equivalent).Excellent written and spoken English.Strong communication, analytical, and technical leadership skills in cross-functional and multinational environments.#J-*****-Ljbffr
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Sterility Assurance Expert
2 settimane fa
latina, Italia Jefferson Wells A tempo pienoRole OverviewThe Sterility Assurance Expert is responsible for ensuring full compliance of aseptic and sterility processes with international regulatory standards (EU GMP, Annex 1, FDA, EMA) and company procedures, while actively contributing to the development and maintenance of a robust Contamination Control Strategy.This position serves as a technical...
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Sterility Assurance Expert
2 settimane fa
latina, Italia Jefferson Wells A tempo pienoRole OverviewThe Sterility Assurance Expert is responsible for ensuring full compliance of aseptic and sterility processes with international regulatory standards (EU GMP, Annex 1, FDA, EMA) and company procedures, while actively contributing to the development and maintenance of a robust Contamination Control Strategy.This position serves as a technical...
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Sterility Assurance Expert
1 settimana fa
Latina, Italia Jefferson Wells A tempo pienoRole Overview The Sterility Assurance Expert is responsible for ensuring full compliance of aseptic and sterility processes with international regulatory standards (EU GMP, Annex 1, FDA, EMA) and company procedures, while actively contributing to the development and maintenance of a robust Contamination Control Strategy. This position serves as a technical...
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Sterility Assurance Expert
3 settimane fa
latina, Italia Jefferson Wells Italia A tempo pienoPer conto di azienda cliente del settore farmaceutico stiamo cercando su Latina una figura di Sterility Assurance Expert.La figura sarà responsabile di garantire la piena conformità dei processi asettici e di sterilità agli standard normativi internazionali (EU GMP, Allegato 1, FDA, EMA) e alle procedure aziendali, contribuendo attivamente allo sviluppo e...
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Sterility Assurance Expert
2 settimane fa
LATINA, Italia Jefferson Wells Italia A tempo pienoPer conto di azienda cliente del settore farmaceutico stiamo cercando su Latina una figura di Sterility Assurance Expert.La figura sarà responsabile di garantire la piena conformità dei processi asettici e di sterilità agli standard normativi internazionali (EU GMP, Allegato 1, FDA, EMA) e alle procedure aziendali, contribuendo attivamente allo sviluppo e...
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Sterility Assurance Leader — Gmp Compliance
2 settimane fa
LATINA, Italia Jefferson Wells A tempo pienoA leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies.The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments.Excellent English and strong technical leadership skills are...
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Sterility Assurance Leader — GMP Compliance
2 settimane fa
latina, Italia Jefferson Wells A tempo pienoA leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies. The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments. Excellent English and strong technical leadership skills are...
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Sterility Assurance Leader — GMP Compliance
1 settimana fa
Latina, Italia Jefferson Wells A tempo pienoA leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies. The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments. Excellent English and strong technical leadership skills are...
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Esperto Di Sterility Assurance E Controllo Contaminazione
2 settimane fa
LATINA, Italia Jefferson Wells Italia A tempo pienoUn'azienda del settore farmaceutico cerca un esperto di Sterility Assurance per garantire la conformità dei processi sterili.La posizione richiede competenze in GMP, leadership tecnica e comunicazione interfunzionale.Il candidato ideale ha una laurea scientifica e un'esperienza significativa in ambienti farmacologici.Lavorerà a Latina e contribuirà a...
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Quality Assurance Pharma
1 settimana fa
latina, Italia Altro A tempo pienoWho are we? Join our team and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in the pharmaceutical field, but above all being an ambassador of our...
