美時化學製藥股份有限公司
English Required
品質系統經(副)理 Quality Systems (Assistant) Manager
10/18 Updated
Full-time
Executive 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/精通、說/精通、讀/精通、寫/精通
Work Experience
10年以上
Job Description
OVERALL OBJECTIVES:
-Provide leadership and oversight of designated GxP Computerized Systems (that have are relevant for Lotus Pharmaceutical) and their support teams to ensure successful delivery of key objectives, as well as compliance with applicable business and regulatory requirements.
-Work with teams to implement quality systems and improvements that meet local business and regulatory requirements.
-Responsibilities include administration and management of the Electronic Document Management System (EDMS), Electronic Quality Management System (EQMS), Learning Management System (LMS), as well as extended support and oversight of other GxP systems.
GENERAL DUTIES:
-Ensure the following key areas of GxP computerized system governance are established and maintained for applicable systems
-Management: Validation planning, supplier assessment, risk management
-Development
1. Validation approach & deliverables – maintain current “as is” validation state
2. Configuration and design
3. Management, development, testing, and review of software
4. Data management
-Operation
1. Support services, performance monitoring, incident management, security, training, user authorizations
2. CAPA, change management, updates/patches, repair activity
3. Data integrity, periodic review, backup and restore, business continuity
-Quality lead on designated Computer Systems implementations, ensuring all regulatory and compliance issues are addressed and documented
-Mentor staff working on GxP computer system validation
-Lead and support improvement projects to solve problems, enhance system capabilities, and expand use of GxP systems to new sites and functional areas in need.
-Work with relevant teams to maintain capabilities for collecting and reporting Quality data and projects, including maintaining Quality SharePoint Portals where necessary.
-Participate in internal and supplier audits as requested.
-Participate in improvement initiatives and programs as requested.
-Stay current with GxP and industry standards
QUALIFICATIONS:
-Bachelor’s degree in pharmacy or life science, or higher degree, with the right combination of extensive experience and success in the pharmaceutical industry
-Education in computer science, coding or programming is a benefit
-Thorough knowledge of pharmaceutical industry, quality systems, computerized system validation, GAMP 5, and relevant GxP and data integrity requirements.
-Experience and skills related to the operation, administration, and overall governance of GxP computer systems and software applications.
-Working knowledge of help desk software/support, databases, SaaS, and analytical reporting
-Strong technical background and ability to explain complex information in simple, clear terms to non-IT personnel. Ability to assess customers IT knowledge and provide appropriate support.
-Proven track record of successful GxP Computer System implementations and governance.
-More than 10 years’ experience in different quality related roles within the pharmaceutical industry
-Good knowledge and experience in Project Management principles and techniques.
-Thorough knowledge of Quality Systems and risk-based decision making.
-Experience dealing directly with regulatory agencies
-Experience and skills in operating across and between different national cultures.
-Good command of Mandarin and English
SKILLS:
-Strong leadership/team management skills
-Credible and confident communicator with good presentation skills (written and verbal).
-Strategic thinker with the ability to influence at all levels
-Strong analytical and problem-solving ability, including identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution.
-Able to work proactively and independently.
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
Pharmaceutical Research and Development Staff
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。
