美時化學製藥股份有限公司
English Required
品質合規(資深)專員 Quality Compliance (Sr.) Specialist
10/16 Updated
Full-time
Mid to Senior Level
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
南投縣南投市
Required
Language Requirements
English
聽/中等、說/中等、讀/中等、寫/中等
Work Experience
2年以上
Job Description
1. Review and enforce adherence to quality standards and agreements.
2. Manage non-conformance investigations and compliance.
3. Oversee GMP and regulatory compliance.
4. GMP Supplier Oversight:
-Oversight the GMP Vender Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both auditors and vendors.
-reviewing supplier audit reports, ensuring they meet Lotus QA Standards and are compliant with Lotus SOPs.
-Submitting observation reports to vendors, communicating response timelines and tracking them to ensure timely responses.
Review of vendor audit responses and managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy.
5. Manage quality assurance tasks including document control and investigations.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
生物學相關、化學相關、藥學相關
Work Schedule
08:00~17:00
Leave Policy
依公司規定
Job Category
Document Controller
QA / QC Engineer
QA / QC Supervisor
南投縣南投市
藥品製造業
美時化學製藥成立於 1966 年，是一個立足台灣、放眼國際的學名藥廠，目前為台灣營收規模最大的製藥公司，專注生產口服癌症用藥並銷售全世界。
美時以亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PMDA、中國 FDA 及巴西 ANVISA 認證的藥廠，全力以高品質、高近用性的藥物滿足未竟的醫藥需求，改善人類生活品質，致力為病患、員工與所有利害關係人創造最大利益。
透過目前足跡廣布台灣、韓國、泰國、越南、新加坡、香港、馬來西亞、菲律賓、與中國的直營市場，以及與一線藥廠成為合作夥伴，美時的高價值產品得以銷售至世界各角落，是少數能進軍所有國際市場的台灣藥廠。
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