Site Head Of Qa Compliance

1 settimana fa


Monza, Italia Thermo Fisher Scientific A tempo pieno

**MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**:
Ensure that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements, through the guidance, coordination and control of the reporting structure.
Promote proper and proactive business partnership with site functions.
Facilitate people and organization development.
**ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES**:
**Quality Systems & Compliance**
- Support and collaborate with Training&Quality System Team to implement the.Pharmaceutical Quality System, according withcGMP regulations and Corporate Standards
- Ensure a proactive site cGMP inspection readiness program, evaluating potential gaps, identifying action plans in collaboration with the involved functions and providing follow up
- Ensure the proper preparation, management and follow up of Regulatory Authorities and Clients inspections
- Ensure timely execution of the internal and external auditing program
- Ensure proper management of suppliers
- Ensure timely preparation of APRs
**Validation and Calibration**
- Collaborate with technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards
- Ensure that production processes and cleaning validation meet cGMP and Corporate Standards through the guidance, coordination and control of the reporting structure
- Ensure that an effective and complaint change control system is in place
**Organization Management**
- Manages performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment
**Budget**
- Support the Quality Director in the budgeting process
**RELATIONS**:
**Internal**
- All the Monza operational functions
- Patheon Sites and Corporate depts.
**External**
- Clients, Regulatory Agencies
**REQUIREMENTS**
**ESSENTIAL**
- Degree in a Scientific Area
**Technical skills**:
- Practical knowledge in GMPs and Regulatory Compliance
- Familiarity with production, validation and supply chain processes.
**Professional Experience**:
- At least 10 years of experience in Pharma Operations.
- Experience in Quality Units of pharmaceutical company.
- Experience in people management and development
**Foreign Languages**:
- Italian
- English
**Personality traits**:
- Leadership, including change management
- Team work
- Listening, negotiation and communication skills
- Strategic thinking
- Pragmatic and oriented to prioritization and results achievement
**(B) DESIRABLE**:
- Knowledge of Sterility Assurance.
- QP nomination by AIFA



  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**: Ensure that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements, through the guidance, coordination and control of the reporting structure. Promote proper and proactive business partnership with site...


  • 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

    3 settimane 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,...

  • Head of Admissions

    2 mesi fa


    Monza, Italia International School of MonzaItaly A tempo pieno

    **Job type**: Full Time, Permanent 28 November 2024 **Job overview**: **International School of Monza**: The International School of Monza is situated in the heart of the city and is in the ideal vicinity of buzzing Milan, the beautiful Italian lakes and ski resorts. We welcome approximately 350 students of nearly 40 nationalities, from ages 2.5 to 18. An...

  • Head Of Admissions

    4 settimane fa


    Monza, Italia International School Of Monzaitaly A tempo pieno

    **Job type**:Full Time, Permanent28 November 2024**Job overview**:**International School of Monza**:The International School of Monza is situated in the heart of the city and is in the ideal vicinity of buzzing Milan, the beautiful Italian lakes and ski resorts. We welcome approximately 350 students of nearly 40 nationalities, from ages 2.5 to 18. An...

  • Head of Wellbeing

    4 giorni fa


    Monza, Italia International School of MonzaItaly A tempo pieno

    **Job type**: Full Time, Permanent 31 January 2025 **Job overview**: Inspired Education is the leading global group of premium schools, with a portfolio of over 116 premium private schools spanning six continents which utilise proven educational practices from every corner of the globe, ensuring over 90,000 students receive a world-class learning...


  • 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...


  • 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...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale! Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and enable the future of...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale! Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and enable the future of...

  • 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...

  • Manager, Qa

    3 settimane 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...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale!Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.You'll find the resources here to achieve your career goals and help take science a...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About Thermo Fisher ScientificWe are a leading provider of innovative solutions in the life sciences industry.Estimated Salary: $80,000 - $110,000 per yearJob DescriptionCompany OverviewThermo Fisher Scientific Inc. is a multinational biotechnology product development company that offers a range of products and services to help our customers advance their...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**: Ensure that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements, through the guidance, coordination and control of the reporting structure. Promote proper and proactive business partnership with site...

  • Head of Wellbeing

    4 giorni fa


    Monza, Italia Inspired A tempo pieno

    Head of Wellbeing **Location**:Monza, IT **Date**:15 Jan 2025 **Application closing date**:14/02/2025 - Inspired Education is the leading global group of premium schools, with a portfolio of over 116 premium private schools spanning six continents which utilise proven educational practices from every corner of the globe, ensuring over 90,000 students...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale!Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.You'll find the resources here to achieve your career goals and help take science a...