Quality Assurance Manager

hace 4 semanas

Santiago de Chile Novartis A tiempo completo

1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?
- The people we serve need you to achieve the extraordinary. That´s why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.-
**Your responsibilities**:
Your responsibilities include, but are not limited to:
- To lead the quality organization in the country in order to ensure that global and local regulations are in compliance.
- Assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
- Ensure that retesting is performed in the country according to local regulations and in compliance with Novartis guidelines.
- Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly.
- Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
- Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation. -Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products
- Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
- Ensure that coordinated contact is maintained with all part Support quality oversight within the Country for 3rd parties/vendors/outsourced activities in alignment with the relevant stakeholders. Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Bachelor's degree in Chemistry and Pharmacy obtained by a national university in Chile.
- Ability to work and lead (a cross-functional team) in a matrix environment
- English and Spanish at an advanced level
- Audit Methodology: Identifying and Testing Controls for Business Risk
- Minimum 5 years working experiences in the pharmaceutical industry with direct experience in QA/QC operations.

**You’ll receive**:
Competitive salary, annual bonus, life insurance, home office policy, flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, Gympass, and virtual self-development tools.**Why consider Novartis?**

21.000. That’s how many people Novartis hires globally every year, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can th

  • Quality Assurance Engineer

    hace 1 semana

    Santiago de Chile Accedo A tiempo completo

    **Santiago**: QAE Intermediate Full-time QAE **About the position**: Quality Assurance Engineer Santiago Intermediate Full-time The multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV, Android TV,...

  • Quality Assurance Engineer Intermediate

    hace 2 meses

    Santiago de Chile Accedo A tiempo completo

    **Santiago**: QAE Intermediate Full-time QAE **About the position**: Quality Assurance Engineer Intermediate Santiago Intermediate Full-time The multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV,...

  • Quality Assurance Engineer Intermediate

    hace 3 días

    Santiago de Chile Accedo A tiempo completo

    **Santiago**: QAE Intermediate Full-time QAE **About the position**: Quality Assurance Engineer Intermediate Santiago Intermediate Full-time The multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV,...

  • Quality Assurance Tester

    hace 2 semanas

    Santiago de Chile Soft Dev Team A tiempo completo

    We are seeking a talented QA Tester to join our team! If you are passionate about software quality, have experience in both automated and manual testing, and possess excellent English language skills, then this position is perfect for you! **Requirements**: - Minimum of 3 years of proven experience in quality assurance, both in automated and manual...

  • Quality Manager

    hace 2 meses

    Santiago de Chile P&P Team A tiempo completo

    ACERCA DE LA VACANTE Funciones del Puesto Manages and executes the compliance assurance processes of the quality management system. Establishes direction and guidelines of quality assurance and quality control processes in the medical devices manufacturing work flow. Oversees the assurance of compliance with the corresponding standardization...

  • Quality Manager

    hace 2 meses

    Santiago de Chile P&P Team A tiempo completo

    **Acerca de la vacante**: **Funciones del Puesto**: Manages and executes the compliance assurance processes of the quality management system. Establishes direction and guidelines of quality assurance and quality control processes in the medical devices manufacturing work flow. Oversees the assurance of compliance with the corresponding standardization...

  • Quality Assurance Engineer Intermediate

    hace 2 meses

    Santiago de Chile Accedo A tiempo completo

    The multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV, Android TV, Chromecast, Web, Smart phones, tablets and more. Accedo is a leading company in this sector and is hiring at multiple locations (Madrid,...

  • Quality Assurance Manager

    hace 1 semana

    Santiago, Metropolitana, Chile Novartis A tiempo completo

    That's the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you're given opportunities to make a genuine impact on our patient driven mission. Here you're surrounded by people who share your determination to tackle the world's toughest medical challenges. Did you ever...

  • Senior Manager, Quality Assurance

    hace 1 semana

    Santiago de Chile Jobs for Humanity A tiempo completo

    Company Description Jobs for Humanity is dedicated to building an inclusive and just employment ecosystem. Therefore, we have dedicated this job posting to individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or hard of hearding, Black, Hispanic, Asian, Military Veterans, the Elderly, the...

  • Clinical Fsp Quality Manager

    hace 3 semanas

    Santiago de Chile Novasyte A tiempo completo

    Job Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define...

  • SAP Quality Assurance

    hace 1 semana

    Santiago de Chile PUMA A tiempo completo

    **YOUR TALENT**: - 2-3 years minimum of experience in SAP Quality Assurance field - Knowledge of development methodologies - Knowledge about ALM tool, Solman Quality Gate and Charm, and Solman Testing Suite - Advance English **YOUR MISSION**: - Lead the S/4HANA EBP Project testing function, do the test planning and test readiness review. This includes...

  • Quality Manager

    hace 1 semana

    Santiago, Metropolitana, Chile P&P Team A tiempo completo

    ACERCA DE LA VACANTEFunciones del PuestoManages and executes the compliance assurance processes of the quality management system.Establishes direction and guidelines of quality assurance and quality control processes in the medical devices manufacturing work flow.Oversees the assurance of compliance with the corresponding standardization...

  • Quality Market Manager, Chile

    hace 2 meses

    Santiago de Chile Marriott International, Inc A tiempo completo

    **Job Number** 23085654 **Job Category** Procurement, Purchasing, and Quality Assurance **Location** Chile Office, Av Presidente Kennedy 5741, Santiago, Región Metropolitana de Santiago, Chile **Schedule** Full-Time **Located Remotely?** Y **Relocation?** N **Position Type** Management **JOB SUMMARY** The Market Quality Manager partners with the...

  • Intermediate Quality Assurance Engineer

    hace 3 semanas

    Santiago de Chile Apply Digital A tiempo completo

    **Who we are**:We’re a global digital transformation partner for change agents. We offer connected thinking to deliver connected results that realize a business’ vision. **What we do**:We empower enterprises to shift to evolving business opportunities, gain powerful insights and deliver experiences that drive growth. **Who we help**:Our 600+ digital...

  • Quality Assurance Engineer- Chile

    hace 3 semanas

    Santiago de Chile Modernizing Medicine, Inc. A tiempo completo

    **At Modernizing Medicine, we look for passionate, innovative, creative Rock Stars!** - **South Florida Business Journal, Best Places to Work 2021**: - **Inc. Magazine Best Workplaces of 2020**: - **Inc. 5000 Fastest-Growing Private Companies in America - 2015 - 2019**: - **Marketing Campaign of the Year for Telehealth - Business Intelligence Group's...

  • Senior Manager, Quality Assurance

    hace 2 semanas

    Santiago de Chile Jobs for Humanity A tiempo completo

    Company Description Jobs for Humanity is dedicated to building an inclusive and just employment ecosystem. Therefore, we have dedicated this job posting to individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or hard of hearding, Black, Hispanic, Asian, Military Veterans, the Elderly, the...

  • Especialista en Quality Assurance

    hace 2 meses

    Santiago de Chile STEFANINI LATAM A tiempo completo

    ¡Sé parte de Stefanini! En Stefanini somos más de 30.000 genios, conectados desde 41 países, haciendo lo que les apasiona y co-creando un futuro mejor. El Especialista en Quality Assurance (QA) en Seguros y Finanzas con enfoque en la metodología Agile desempeña un papel esencial en garantizar la calidad y la eficiencia de los productos y servicios...

  • Especialista en Quality Assurance

    hace 3 semanas

    Santiago de Chile STEFANINI LATAM A tiempo completo

    ¡Sé parte de Stefanini! En Stefanini somos más de 30.000 genios, conectados desde 41 países, haciendo lo que les apasiona y co-creando un futuro mejor. El Especialista en Quality Assurance (QA) en Seguros y Finanzas con enfoque en la metodología Agile desempeña un papel esencial en garantizar la calidad y la eficiencia de los productos y servicios...

  • Quality Specialist

    hace 2 meses

    Santiago de Chile Normet A tiempo completo

    We are a fast growing and innovative company with a mission to lead the transformation into a more digital and sustainable tomorrow. At Normet everyone is provided with opportunities to reach their full potential, valuing the differences of diverse backgrounds and experiences. - Preparing and implementing quality assurance policies and procedures. -...

  • Quality Assurance Specialist for Educational Videos

    hace 1 semana

    Santiago de Chile Edpuzzle A tiempo completo

    **About us** Have you always wanted to put your passion for education to use on the job? Would you like to work with an incredible team making an impact on learning around the world? If you answered yes, we can't wait to meet you! And just who are we? Edpuzzle is a leading edtech company with offices in San Francisco and Barcelona and nearly 10 years of...