Qa Sterility Assurance Manager, Nerviano Site
Pubblicato il 31-07-2026 - Chiesi Group_Disabled in Milano
ppbWho we are /b Chiesi is an international research-focused biopharmaceutical group with 90 years of experience, present in over 30 countries, with headquarters in Parma, Italy. More than 8,000 employees across the group are united by a single purpose: to promote a healthier world for people, patients, and the planet. This is what drives us in researching, developing, and marketing innovative drugs in our main therapeutic areas. Learn more here. At Chiesi, we think about future generations, promoting sustainable and purpose-driven innovation. This fosters a culture of reliability, transparency, and ethical behavior at all levels. As a Benefit Corporation and certified B Corp, we have integrated sustainability into our statute and constantly measure our impact. Diversity and inclusion are at the heart of our identity. We believe that our differences make us stronger. We are a dynamic ecosystem of passionate and talented people, united by strong values, each bringing unique perspectives that help us continuously challenge the status quo for the better. /p ul libParma (Italy) /b, the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations, and sterile suspension vials for endotracheal administration are produced. /li libBlois-La Chaussée Saint Victor (France) /b, a center of excellence specialized in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and export to other markets, effectively responding to both local and international needs. /li libSantana de Parnaiba (Brazil) /b, specialized in the production of pressurized solutions for inhalation therapy (pMDI). Additionally, it has an area dedicated to nasal sprays for the European market. /li /ul pbQuesta posizione è in Chiesi Group /b /p pIl processo di selezione sarà interamente gestito Chiesi Group /p pQuesta possibilità è disponibile in Nerviano - Italy, Milan - Italy. /p pbWho we are /b Chiesi is an international research-focused biopharmaceutical group with 90 years of experience, present in over 30 countries, with headquarters in Parma, Italy. More than 8,000 employees across the group are united by a single purpose: to promote a healthier world for people, patients, and the planet. This is what drives us in researching, developing, and marketing innovative drugs in our main therapeutic areas. Learn more here. At Chiesi, we think about future generations, promoting sustainable and purpose-driven innovation. This fosters a culture of reliability, transparency, and ethical behavior at all levels. As a Benefit Corporation and certified B Corp, we have integrated sustainability into our statute and constantly measure our impact. Diversity and inclusion are at the heart of our identity. We believe that our differences make us stronger. We are a dynamic ecosystem of passionate and talented people, united by strong values, each bringing unique perspectives that help us continuously challenge the status quo for the better. /p ul libParma (Italy) /b, the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries.
Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations, and sterile suspension vials for endotracheal administration are produced. /li libBlois-La Chaussée Saint Victor (France) /b, a center of excellence specialized in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and export to other markets, effectively responding to both local and international needs. /li libSantana de Parnaiba (Brazil) /b, specialized in the production of pressurized solutions for inhalation therapy (pMDI). Additionally, it has an area dedicated to nasal sprays for the European market. /li /ul pIn 2024, the bBiotech Center of Excellence /b was inaugurated in Parma, a new hub of excellence for the research, development, and production of biological drugs. The Biotech Center of Excellence focuses on biotechnological innovation, with particular attention to the development of monoclonal antibodies, enzymes, and other complex proteins. In 2025, a new investment in bNerviano /b (Italy) was announced with the construction of a new facility for the production of therapeutic solutions. The facility will be primarily dedicated to the production of low-carbon footprint inhalers, dry powder inhalers, and sterile biological products. /p h3What you will do /h3 pbQA Sterility Assurance Manager /b is responsible for defining, implementing, and overseeing the Sterility Assurance strategy for the Nerviano plant for the production of sterile forms under aseptic conditions. Ensures full compliance with EU GMP regulations, particularly Annex 1, and US FDA cGMP, ensuring that aseptic processes, critical utilities, sterile areas, and laboratory activities are designed and managed to prevent any risk of microbiological, particulate, and pyrogenic contamination. Guides the implementation of Contamination Control Strategies (CCS), continuous improvement, and process quality. /p h3You will be responsible for /h3 ul liDeveloping and maintaining the Site Sterility Assurance Program in accordance with EU Annex 1, EU GMP Vol.4, 21 CFR 210/211, and FDA Guidance, supervising microbiological aspects, sterilization, sanitization, disinfection, and bioburden management programs. /li liDefining the Contamination Control Strategy (CCS) and ensuring its implementation at the site level, coordinating microbiological risk assessment activities (risk assessment, FMEA…). /li liSupervising aseptic processes and supporting the definition of requirements for: /li liHVAC and room classification /li liClean utilities (WFI/PW, Clean Steam, Compressed Gas) /li liMaterial and personnel flow /li liEquipment design /li liSterilization processes /li liAir flow visualization studies (smoke test) /li liSupporting the design and validation of facility layout, personnel and material flows,
sanitization and sterilization processes, and aseptic manufacturing processes. /li liDefining and approving the Aseptic Process Simulation (APS) program, supervising operational activities, reviewing results, and managing associated deviations and trends. /li liDefining and supervising the Environmental Monitoring (EM) program: air, surfaces, personnel, and evaluating related microbiological and particulate trends with definition of improvement actions and CAPAs where necessary. /li liManaging the qualification strategy for classified rooms. /li liValidating cleaning procedures for microbiological contamination control and defining associated holding times. /li liSupervising investigations related to deviations concerning: /li liaseptic behavior /li lienvironmental and personnel monitoring /li liutilities microbiological excursion /li lipre-filtration bioburden excursion /lilisterility test failure /li liAPS failure /li liParticipating in Change Control processes for aseptic equipment/processes, environmental systems, layout, critical procedures, sterilization systems, personnel and material flows, and defining impacts with relative management of site CCS updates. /li liParticipating in and supporting regulatory inspections (AIFA, EMA, FDA) and defining CAPAs for any non-compliance. /li liMonitoring regulatory compliance and updates. /li /ul h3You must have /h3 ul liDegree in Pharmaceutical Chemistry and Technology, Biotechnology, Biology, or related fields. /li li7+ years in pharmaceutical contexts - production of sterile drugs under aseptic conditions - of which at least 5 in QA sterility assurance roles. /li liIn-depth knowledge of sterility assurance requirements, EU-GMP Annex 1, EU GMP Parts I II – Quality management manufacturing principles, PIC/S PI 007 PI 012 (harmonized with Annex 1), FDA Guidance - Aseptic Processing, USP 1211 Sterility Assurance, ISO guidelines in the cleanroom area, and ability to apply QRM (ICH Q9), QMS (ICH Q10), and data integrity (ALCOA+). /li liBackground in team management and cross-functional coordination. /li liExcellent knowledge of root cause analysis tools. /li liOrganizational skills, problem-solving, and teamwork. /li liGood knowledge of English. /li /ul h3Location /h3 pNerviano, Milan /p h3What we offer /h3 pWhenever your journey at Chiesi begins, it will lead you to exciting possibilities. Your future is at the center, and we are committed to supporting your development in a dynamic and friendly environment, with access to resources and training at every stage. We offer high-level benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. The compensation package is competitive and includes base salary, performance bonuses, and benefits aligned with the external market. Additionally, we offer flexible work arrangements, remote work options, and tax services for international colleagues, designed to help you thrive. /p pChiesi is an equal opportunity employer and is committed to hiring a diverse workforce at all levels. All qualified applicants are considered for employment based on aptitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other criterion protected by law. /p /p #J-18808-Ljbffr