**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.

📌 Associate Process Expert (Baja California Sur)
🏢 Novartis
📍 Baja California Sur