Manager, Qa

1 settimana fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Monza site is looking for a Quality Assurance Manager and Qualified person to lead a QA Operations team and bring valuable contributions both as individual professional and people leader.
MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES:
As QA Manager and QP you will coordinate a team of Quality Operations professionals and wield authority inside the Plant in regards of what foreseen by law (D. Lgs 219/06 and later supplements) towards Authorities, in particular towards the Italian and European Public Health Authorities and being the liaison between Authorities and the plant.
You will be responsible, as foreseen by DPR 309/90 and later supplements, of management of the controlled drugs, only if authorized by Ministero della Salute.
ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:
- Acting as liaison between the Plant and the National Public Health Authorities (AIFA, UCS), National Public Safety Authority (Police, National Exercise and tax crimes authority, ASL) in regard of drugs and controlled drugs.
- Assure that each batch of drug is produced and controlled in compliance with current laws and with conditions defined in the product marketing authorization.
Assure that each batch of drug coming from a country not belonging to the European Union is properly analyzed, that a quantitative analysis of all active principles is made and that any other test necessary to assure the quality of products is made, in compliance with what indicated in the product marketing athorization, reserved the right of what defined by mutual agreements.
Certify and attest on specific documentation that each batch is produced in compliance with the provisions indicated in the product marketing authorization.
Release the finished products for the market (Batch Release).
- Authorize the unpacked products release for the delivery to clients.
Guarantee that all documentation required by law and by GMP is properly compiled and filed for the right period of time.
- Communicate immediately to AIFA and to the Company any substantial irregularity in the products already launched in the market.
- Collaborate actively in occasion of each inspection by Health Autorithies and guarantee that any action requested by the Authorities during the inspection is made. Certify that the pharmacologically active substances used within the plant have been produced in compliance with GMP
The QP, in order to carry out his role, avails himself of the staff settled in the legislative decree 219/06 and in the GMP (personnel) and assures, thanks to this structure, the
**Requirements**:
- MsC in CTF, Pharmacy, Biology or similar
- Deep understanding of GMP regulations and sterile injectable drugs manufacturing and batch release process
- Knowledge of regulatory matters and dossier
- At least 10 years of experience in a Sterile Injectables manufacturing faciltuy and at least 6 years of experience in the QA function
- Experience in a multinational/international environment is preferred
- Fluent English and Italian
- Proven People Leadership skills
- Active listener, with good communication and negotiation skills
- Problem solver, focused on data-informed decision making and risk analysis.
- Goal and client oriented
- Eligible to act as a QP in Italy
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Join Us

  • Electrical Qa/Qc Engineer

    3 settimane fa

    Monza, Italia Adh Personal Thüringen A tempo pieno

    Eurointerim S.P.A. filiale di Milano-società di Ricerca & Selezione del personale per affermata ed internazionale azienda cliente attiva nel settore della progettazione e del cablaggio di infrastrutture elettriche, ricerca un profilo professionale da inserire per ampliamento organico:ELECTRICAL QA/QC ENGINEER Job DescriptionIl candidato, dopo un primo...

  • Manager, QA

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Specialista QA del Progetto Deviazioni

    3 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **Descrizione del Lavoro:**Nella nostra squadra di Pharmaceutical Development Service (PDS) a Monza, impegnata nella produzione di prodotti iniettabili destinati alla sperimentazione clinica, cerchiamo un Specialista QA del Progetto che si occupi delle attività seguenti:• Controllo dei Lotti per Rilascio: Collaborare con la QP e il Quality Operations...

  • Sr Manager, QA Compliance

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...

  • Sr Manager, Qa Compliance

    4 giorni fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion.Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...

  • Lead QA Technician

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **SCOPO DELLA POSIZIONE/RESPONSABILITÀ**: Alle dipendenze del QOPS Team Leader di riferimento e del QOPS Supervisor, supporta la Persona Qualificata nel giudizio sui lotti prodotti e sull’ambiente di lavorazione, attraverso la verifica della documentazione e delle altre informazioni necessarie. Dietro la guida e il coordinamento del Team Leader effettua...

  • Lead QA Technician

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Other **Environmental Conditions** Office **SCOPO DELLA POSIZIONE/RESPONSABILITÀ**: Alle dipendenze del QOPS Team Leader di riferimento e del QOPS Supervisor, supporta la Persona Qualificata nel giudizio sui lotti prodotti e sull’ambiente di lavorazione, attraverso la verifica della documentazione e delle altre informazioni...

  • Pds QA Project Specialist

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Entrerai a far parte dell'unità Pharmaceutical Development Service (PDS) dello stabilimento di Monza, interamente dedicata alla produzione di prodotti iniettabili finalizzati alla sperimentazione clinica. In qualità di QA Project Secialist ti occuperai delle seguenti attività: **COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**: **Controllo lotti per rilascio** -...

  • Senior Quality Assurance

    3 mesi fa

    Monza, Italia Page Personnel A tempo pieno

    La risorsa , riportando al QA Manager, si occupera' di: Collaborare nella gestione di convalide di processo/cleaning, qualifica di apparecchiature ed impianti; Collaborare nella gestione di deviazioni, OOS/OOT, Root-Cause e relative CAPA; Collaborare nella redazione di Product Quality Review, SOP, VMP; Collaborare nell'implementazione del Sistema Qualità;...

  • QA Documentation

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) When you’re part of Thermo Fisher Scientific, you’ll do exciting work, and join a team that values performance, quality and innovation. As part of a...

  • Quality Assurance Support

    7 mesi fa

    Monza, Italia Viatris A tempo pieno

    Meda Pharma S.p.A. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Quality Compliance Sr Manager

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Are you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of approximately $40...

  • Quality Compliance Sr Manager

    4 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Are you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of...

  • Quality Compliance Sr Manager

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAre you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of approximately $40...

  • Quality Assurance Operations Specialist

    3 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office SCOPO DELLA POSIZIONE/RESPONSABILITà Alle dipendenze del QA Ops Team Leader di riferimento, supporta la Persona Qualificata nel giudizio sui lotti prodotti e sull’ambiente di lavorazione, attraverso la verifica...

  • QA Progettista di Qualità con Esperto delle Deviazioni

    2 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    La posizione si trova presso la nostra sede di Monza, nell'unità Pharmaceutical Development Service (PDS), dove collaborerai con un team di esperti nella produzione di prodotti iniettabili per la sperimentazione clinica.Compiti Specifici:Supportare il Quality Operations Manager e il Responsabile della Qualità nel rilascio dei lotti di prodotto, assicurando...

  • Quality On The Floor Specialist

    7 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World leader in Serving Science, è alla ricerca di un Sr QA Technician di supporto all'area Quality Operations. Le mansioni principali sono: In base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP...

  • Quality On The Floor Specialist

    7 giorni fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World leader in Serving Science, è alla ricerca di un Sr QA Technician di supporto all'area Quality Operations.Le mansioni principali sono:In base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel...

  • Quality On The Floor Specialist

    4 giorni fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World leader in Serving Science, è alla ricerca di un Sr QA Technician di supporto all'area Quality Operations.Le mansioni principali sono:In base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel...

  • Pds Purchasing&Finance Intern

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality, and innovation.As part of a successful, growing global organization, you will be encouraged to perform at your best.With revenues of more than $35 billion and...