Associate Process Expert

**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-functiona...

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