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 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 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 Preventative 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 behaviours.
- ** 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 requirement

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.


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