北京招聘

1. Review batch documents and records to assure that the product quality conforms to specifications and that batch manufacturing activities are in compliance with Novartis Quality Policies and local regulatory and GMP requirements.
2. Ensure that product quality relevant Documentation is archived completely. The updated version is available in the working sites, and its content is understood and implemented properly.

3. Perform the oversight review as shift QA.
4. Provide effective compliance supporting and services to others
5. Access and availability of know-how in respect to state of the art GMP and future trends in the field of GMP, IPC, Validation etc.

Principal Tasks

1. Review of batch documents and records to assure that the product quality conforms with specifications and that batch manufacturing activities are in compliance with Novartis Quality Policies and local regulatory and GMP requirements.
2. Master BD management. Prepare, review and check the batch documentation for correctness, completeness in order to ensure that product is manufactured and controlled in compliance with cGMP and in accordance with the requirement of the marketing authorization. Safely archive the related documents for the prescribed date.
3. GMP monitoring in PUs, Perform the oversight review as shift QA to ensure the Products' production activity compliance with Novartis Quality Policy and GMP requirement.
4. Identify quality related weak-points and gaps in PUs and initiate corrective measures and support investigation.

Special Tasks

1. Assist QA investigation for noncompliance.
2. Give basic training for PU employees as the purpose of RFT improvement.
Others
1. Attend to any other work related assignment, which may be given by the superior.

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘