美時化學製藥股份有限公司
Tiếng Anh Điều kiện
(資深)研發品保專員 (Sr.) DQA Specialist
11/13 Cập nhật
Toàn thời gian
Mới tốt nghiệp
Tiếng Anh Điều kiệnLương & địa điểm làm việc
Thỏa thuận
(Thường từ 40.000NTD trở lên)
南投縣南投市
Điều kiện
Yêu cầu ngôn ngữ
Tiếng Anh
聽/中等、說/中等、讀/精通、寫/精通
Kinh nghiệm
不拘
Mô tả công việc
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
Số lượng tuyển dụng
1~1人
Trình độ học vấn
大學(學院)以上
Yêu cầu ngành học
生物學相關、化學相關、醫藥衛生學科類
Giờ làm việc
08:00~17:00
Chế độ nghỉ
週休二日
Loại công việc
Pharmaceutical Research and Development Staff
QA / QC Engineer
ISO / Quality Assurance Staff
