**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
🏢 Novartis
📍 Baja California Sur