美時化學製藥股份有限公司
(資深)研發品保專員 (Sr.) DQA Specialist
9/18 Updated
Array
English Required
Full-time
Entry-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/精通、寫/精通
Work Experience
不拘
Job Description
1. Responsible for ensuring “Good Laboratory Practices” required for analytical research and development , working knowledge of good development/manufacturing practices of formulation development will be added advantage.
2.Compliance review of API, Raw materials, Packaging materials documentation.
3.Compliance review of Stability data for submission batches documentation at regular intervals.
4.Ensure Document management archival procedure followed in place and support for compliance.
5.Active participate in Internal audit on all functional area pertaining to quality system and compliance and support regulatory audits readiness.
6.Ensure compliance of issuance/document control towards internal/external stake-holders.
7.Compliance review of raw data of Regulatory submission and Audit focused documents ensure error free documentation.
8.Conduct training-based training need identification, co-ordinate internal and external training programs and maintain training records of the team members.
9.Support document review for CTA documents.
10.Review and approve of New Equipment qualifications within R&D
11.Ensure Equipment/Instrument calibration and Qualification/Requalification programs adequacy as per the schedule.
12.Ensure Document compliance review at respective stages of Product development at kick off stage, Pilot Bio, Submission batches and filing stage.
13.Regular inspections on laboratories of development labs of both analytical and formulation
14.Any other responsibilities given Head of the Department /Management
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、醫藥衛生學科類
Work Schedule
08:00~17:00
Leave Policy
週休二日
Job Category
Pharmaceutical Research and Development Staff
QA / QC Engineer
ISO / Quality Assurance Staff
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。
