面議(經常性薪資達4萬元或以上) 新竹縣竹北市 5年工作經驗 1天前更新
1.Review and approve validation/qualification/re-qualification protocols and reports for manufacturing and laboratory equipment.
2.Review and approve calibration records, ensuring traceability and accuracy.
3.Ensure accurate documentation and records management in alignment with GMP guidelines.
4.Experience in change control, deviation management, environmental monitoring, or microbiology is a plus.
5.Experience with TrackWiae is an advantage.
6.Familiarity with computerized system validation (CSV) and data integrity compliance.
7.Strong knowledge of GMP regulations and quality management systems.
8.Excellent problem-solving and communication skills.
9.More than 3 years of experience in pharmaceutical QA or related fields.
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