Associate Process Expert

hace 2 semanas

Insurgentes, México Novartis A tiempo completo

**Summary**:
This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department.

**About the Role**:
**Deviation and Investigation Management**:

- Open deviations and assess the criticality of the deviation within required timeframes
- Assess impact to any products involved in deviations, ensuring product impact is assessed in alignment with batch release activities
- Author investigations
- Owning investigations and developing corrective actions
- Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
- Ensures robustness (complete, accurate and defendable) of all critical and major investigations
- Author and execute any experiments or runs to support investigations
- Work cross-functionally to assess and analyze deviations and investigations to determine impact
- Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.

**Corrective and Preventive Actions**:

- Generation and documentation of effective corrective and preventative actions
- Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
- Monitor and ensure effectiveness checks of CAPAs are conducted
- Communicate to the production team any training or awareness events to reinforce quality behaviors.

**MES Order Management**:

- Generation of manufacturing orders within the MES system, as required.

**Training**:

- Develop training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.
- Maintain compliance with training requirements.

**Key Performance Indicators**:

- Quality measures (e.g., deviations, oos rate)
- Schedule adherence to operational model
- Opening and closing investigations within time frame
- Production right first time
- Costs and budget (e.g. overtime)

**Ideal Background**:
**Education**: Bachelor's degree with 2-5 years of work experience in the pharmaceutical industry or equivalent. An advanced degree is desirable.

**Languages**: Fluent in speaking / writing in English

**Experience**:

- 2-5 years of related pharmaceutical experience preferably in a production, QA, and/ or QC related role preferred. Direct experience working in a GMP and aseptic or sterile environment is required. Cell & gene therapy experience highly desired.
- Investigator Certified required
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Experience with 1QEM

Division

Operations

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Associate Process Expert

    hace 6 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: This role will author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. **About the Role**: **Deviation and Investigation Management**: - Open deviations within required timeframes - Author investigations - Owning investigations and developing corrective...

  • Associate Process Expert

    hace 2 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department.**About the Role**:**Deviation and Investigation Management**:- Open deviations and assess the criticality of the deviation within required timeframes- Assess impact to any...

  • Payroll Expert

    hace 3 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:Support the development of Payroll and P&O processes, principles, and guidelines for clients, as well as coordinate data analysis and evaluation, in support of the implementation and/or maintenance of processes / services / continuous improvement in Payroll.HybridLocation: México, CDMX**About the Role**:Key Responsibilities:- Support evaluation...

  • P2p Process Excellence

    hace 2 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: This position is responsible for overseeing operational stability and excellence throughout the E2E process and the extended team of TCS. Ensuring standards, performance and KPIs within their Regions and across other global NGSCS. Ensuring the design, global standardization and implementation of Service Delivery tools and models to improve and...

  • Senior Associate, Manufacturing Technical Support

    hace 6 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: The Remote Senior Associate, Manufacturing Technical Support, provides support for all process-specific issues to manufacturing. **About the Role**: **Responsibilities**: - Authors manufacturing investigations and meets all targets for timely closure and CAPA completion. - Supports steward for assessment of technical changes, establishment of...

  • Admin Process Expert

    hace 4 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:Responsable de la entrega independiente de servicios administrativos completos en un contexto local y global. Garantizar que los níveles de servicio se cumplan de acuerdo con los requisitos del sitio.**About the Role**:**Principales responsabilidades**:- ** Apoyo administrativo general**: Se encarga de tareas administrativas generales y mantiene...

  • Human Resources Expert

    hace 2 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:As a Human Resources Expert (People Engagement Expert) you will have an exciting opportunity to gain hands-on experience using innovative Huma Resources systems and positively impact the employee life cycle. You will play a crucial role in upholding the quality of services for our US and Mexican employees and partners by promptly and effectively...

  • Project Manager Process Governance Assoc. Dir. Ddit

    hace 1 semana

    Insurgentes, México Novartis A tiempo completo

    **Summary**:As an Associate Director Assoc. Dir. DDIT M&A DE Process Governance, you will play a crucial role in the Deal Enablement team.This role acts as the guardian of process adherence, ensuring that all M&A IT teams follow the established frameworks, tools, and methodologies when planning and executing M&A IT deals. While governance is the foundation,...

  • Benefits Expert

    hace 2 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:**About the Role**:- #LI-Hybrid**Key Responsibilities**:- Support the team in the operational conversion of Benefit strategic objectives.- Support and implement competitive and cost effective benefit programs that are in line with corporate Rewards guidelines to attract and retain talent.- Provide data support for survey submissions.- Participate...

  • Benefits Expert

    hace 2 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**: **About the Role**: - #LI-Hybrid **Key Responsibilities**: - Support the team in the operational conversion of Benefit strategic objectives. - Support and implement competitive and cost effective benefit programs that are in line with corporate Rewards guidelines to attract and retain talent. - Provide data support for survey submissions. -...