Quality Assurance Associate

hace 2 días

Tlahuac, México Marken A tiempo completo

**Title**:Quality Assurance Associate**Job Purpose**:The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies.The QAA I also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.**Main Duties and Responsibilities**:- Implement, communicate and maintain company’s quality systems, in compliance with Marken’s Global QMS requirements.- Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.- Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.- Support on internal audits.- Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.- Coordinate and complete Client Quality Questionnaires including supporting documentation as applicable, in accordance with the SOP.- Collate issues, CAPA, Risk Assessment, Change Control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.- Identify relevant GxP/ Quality related training needs and deliver training where required.- Ensuring that the Marken Quality System and GxP Program are implemented and maintained.- Ensuring the accuracy and quality of records and documents.- Participate actively in all the internal Quality and/ or designated meetings.**Requirements**:- Minimum of 1 year of experience working in a Quality Assurance role within a GSP/GMP/GDP/GCP regulated position- High/ Secondary School diploma/ or equivalent with experience in relevant job-related skill- Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice and Good Storage Practice guidelines- Related knowledge of local regulations- Detailed oriented- Oral and written communication skills- Good interpersonal skills- Organized, methodical, and efficient approach to work- Proficient use of Microsoft Office- Fluent in English, Multilingual in Spanish and English preferred- Knowledge of Cold chain supplies and logistics, Storage, and distribution for pharmaceutical products preferred- Knowledge and understanding of GDP and ISO Compliance desired- Previous experience in Quality Management Systems preferred**Marken** is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.**Moving Our World Forward by Delivering What Matters.

  • Quality Assurance Associate Ii

    hace 1 semana

    Tlahuac, México Marken A tiempo completo

    **Title**: **Quality Assurance Associate II** **Job Purpose**: The Quality Assurance Associate II (QAA II) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation,...

  • Quality Assurance Associate

    hace 3 semanas

    Tlahuac, México Marken A tiempo completo

    **Title**:Quality Assurance Associate**Job Purpose**:To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review.**Main Duties and Responsibilities**:Maintain the culture of the importance of an integrated quality system within the companyTrainer of topics related to Quality for vendors and MKN employeesSupport...

  • Quality Assurance Specialist I

    hace 3 semanas

    Tlahuac, México Bausch Health Companies A tiempo completo

    Quality Assurance Specialist I (7884)**Career Opportunities: Quality Assurance Specialist I (7884)**Requisition ID **7884** - Posted - **Mexico - Tecnofarma** - **Quality** - **MX - Tecnofarma** - City (4)**Químico de Aseguramiento de Calidad**- Garantizar que la documentación de los expedientes de fabricación se resguarde segura, controlada y disponible,...

  • Quality Assurance

    hace 1 semana

    Tlahuac, México P3 GROUP CONSULTING A tiempo completo

    Important company of the Automotive Sector requests Quality Assurance**Description**:- Create and maintain test cases and test matrix- Perform multiple types of tests (integration, smoke tests, functional, gray & black box test, etc)- Test case execution- Report execution results, and report defects founds- Tracking and sign off on reported defects- Create...

  • Auditor, Quality Assurance

    hace 1 semana

    Tlahuac, México ICON A tiempo completo

    **Title: Senior Auditor (Technology & CSV)**: **At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.** **Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as...

  • Quality Assurance

    hace 1 semana

    Tlahuac, México Capital Intelectual A tiempo completo

    **Quality Assurance** **Requisitos**: **Experiência mínima de 3 años en las áreas**:Tecnologías de la información, Sistemas, Informática, Desarrollo **Experiência mínima de 3 años en los siguientes puestos **:Testing en general, Analista de Calidad de sofware, Analista de Operaciones. **Licenciatura**:Informática, Ingeniería Sistemas,...

  • Quality Assurance Anaylst

    hace 2 semanas

    Tlahuac, México AGS LLC A tiempo completo

    **Job Overview** The goal of the QA Analyst is to focus on the overall quality of the products before release. A skilled analyst will spend a significant amount of time on risk evaluation and requirements tracking, then use that information for preparing test plans. A minority of time will be spent on test execution. Career growth can be directed towards QA...

  • Quality Assurance Analyst

    hace 5 días

    Tlahuac, México GP Strategies Corporation A tiempo completo

    GP Strategies Corporation is one of the world's leading talent transformation providers. By delivering award-winning learning and development solutions, we help organizations transform through their people and achieve meaningful change. GP Strategies has delivered our innovative consulting, learning _services,_ and talent technology solutions to over 6,000...

  • Quality Assurance Analyst

    hace 3 días

    Tlahuac, México GP Strategies Corporation A tiempo completo

    GP Strategies Corporation is one of the world's leading talent transformation providers. By delivering award-winning learning and development solutions, we help organizations transform through their people and achieve meaningful change. GP Strategies has delivered our innovative consulting, learning _services,_ and talent technology solutions to over 6,000...

  • Quality Assurance Specialist

    hace 1 semana

    Tlahuac, México DiDi Global A tiempo completo

    Company Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...