Quality Assurance Engineer

4 weeks ago


Suzhou, Jiangsu, China Roche Full time
Main Responsibilities
As a Quality Assurance Engineer at Roche, you will be responsible for managing and coordinating external regulatory requirements, notifying stakeholders, and driving compliance assessment for mitigation actions. You will also review process documents, submit manufacturing registration documents, and coordinate internal audit programs. Additionally, you will prepare inputs for the Quality Management Review and evaluate Q-data for corrective and preventive actions. Your expertise will be shared with global teams and other sites as a China GMP expert.

Key Responsibilities
1. Manage external regulatory requirements and notify stakeholders.
2. Drive compliance assessment for mitigation actions.
3. Review process documents and submit manufacturing registration documents.
4. Coordinate internal audit programs and ensure compliance.
5. Prepare inputs for the Quality Management Review and evaluate Q-data.

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