Summary
~确保并支持整体GxP合规性和诺华质量管理体系的合规性。
About the Role
Major Accountabilities
Operational
- Provide shop-floor QA support and oversight of production and testing activities, ensures compliance with cGxP, ISO9001, incl. data integrity and eCompliance
- Batch document review, support product release
- Support deviation and compliant investigations within MU, QC, Engineering and warehouse and other relevant areas.
- Performs routine documentation activities
- Supports change control activities
- Review and approval of production and QC documents and records
- MBR review
- IPC oversight
- Support OpEx improvement projects
- Support internal and external audit or inspection activities
HSE
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
Key Performance Indicators
- Executes product-related activities in timely manner according to cGxP and in compliance with registration
- Demonstrated positive trends in key quality management process measures. Successfully support continuous improvement projects
Experience:
- More than 3 years of experience in pharmaceutical quality control, quality assurance or production
- Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
Education & Qualification:
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- Qualified Person (depending on local requirements)
Languages:
Good (oral and written) in English; fluent in local language (oral and written)
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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无障碍及便利 设 施
诺华 承 诺 与残障人士共事并 为 他 们 提供合理的便利 设 施。如果您由于健康状况或残障 在招聘 过 程的任何 环 节 需要合理便利 设 施 或者 为 了履行 职 位的基本 职 能 请发 送 电 子 邮 件至 [email protected] 告知您的需求和 联 系方式，并在 邮 件中附上您的 职 位申 请编 号。
