The Packaging Analyst plays a critical role in ensuring the effectiveness of packaging operations by training and qualifying Inspectors, updating SOPs and Work Instructions, performing periodic reviews in OneVault, creating and maintaining defect qualification sets, trending inspection data, and supporting investigations and process improvements.

Responsibilities:

Training/Qualification
- Train and qualify Inspectors for Core 1 Products
- Create and manage defect qualification sets
- Trend batch data from inspection records
- Generate and update controlled documents, procedures, and work instructions in OneVault
- Initiate, document, and support change controls (Global Trackwise) and process updates
- Complete and document investigations, CAPAs, non-conformances, root cause analysis, and system risk assessments
Administration/Meetings
- Attend Tier and CAPA Investigation meetings with internal stakeholders
- Support other duties as required

Knowledge of regulatory requirements in a pharmaceutical GxP environment
Minimum 3 years’ experience in a regulated environment
Preferred: Experience with S4 HANA, OneVault, Global Trackwise, MS Office

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