Job Description

Title: QA Associate Deviation

Mon-Fri: 9 AM - 5 PM

Details:

The candidate is responsible for hands on, day-to-day cGMP activities as trained and required per schedule. They interact directly with site staff, who are performing the daily operational functions (e.g. manufacturing, QC, etc.), in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support area ensure adherence to policies, SOPs, and cGMP requirements.

• Initiation, review and approval of initials & Impact assessment, deviation (with focus on minor and major), quality event and OOS/OOE/OOT investigations and CAPA plan establishment in accordance with applicable SOPs.
• Participates in activities associated with event resolution and CAPAs
• Implements and ensures adherence of appropriate regulations and Novartis quality standards.

Exp-3 years to 5 years

• Additional activities may be assigned for training and completion as required.
• Demonstrates and role models the Novartis values and behaviors.

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