美時化學製藥股份有限公司

1. 工作態度正向、積極主動學習、樂於接受工作挑戰之人格特質
2. 具英文溝通能力 (TOEIC>750)
3. 兼具工程/機械/機電/藥學/science/資訊等背景，並有志於製造業者發展者。

1.協助主管規劃廠房、設備、生產、Artwork、品質制度等運作落實，以提昇部門績效。
2.協助各類專案之規劃與執行。
3.完善人才培訓體系及晉升發展管道。
4.100％藥廠CGMP訓練。

1. Familiar with PIC/S
2. Experience with US/EU/TFDA inspections
3. Familiar with electronic management system
4. Familiar with CFR Title 21
5. Familiar with EudraLex Vol. 4
6. Good interpersonal/communication skills, ability to interact effectively in a team environment within the functional team and with all cross functions and attention to details.

Maintain and update the Corporate Quality Manual and Standards to comply with FDA, EMA, ANVSIA, ICH, and PIC/S regulations.

Conduct regulatory surveillance, monitor updates, and revise quality standards as needed.

Ensure compliance across all Lotus sites through collaboration, audits, and corrective actions.

Oversee supplier and third-party qualifications, including GMP audit scheduling, report reviews, and responses to findings.

Support regulatory inspections and customer audits, develop CAPA plans, and implement necessary revisions.

Manage GMP compliance, non-conformance investigations, and adherence to quality agreements.

Collaborate with cross-functional teams to meet GxP requirements and drive continuous improvement.

Handle document control, quality investigations, and compliance enforcement. Manage budgets effectively, ensuring optimal resource allocation.

Possessing the following qualifications is considered advantageous:
1. Familiar PIC/S GMP
2. Experience with US/EU/TFDA inspections

★輪班制，做二休二平均工作日15天
日班：08:00 - 20:00
夜班：20:00 - 08:00

★加發津貼
輪班：3,500-4,000 元/月
夜班：400 元/天

1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines.
2. Support day-to-day Quality Assurance - Operations.
3. Perform batch disposition activities within specified timelines.
4. Ensure timely review of batch records, SOPs, investigations, and adherence to
quality agreements.
5. Set meaningful goals, metrics for groups, and manage performance.
6. Ensure safe, quality, and timely work.
7. Participate in continuous improvement projects, including QA systems and
shopfloor processes.
8. Manage non-conformances investigation and compliance.
9. Ensure quality production and operation in accordance with schedule.
10. Quality Assurance management, covering documentation control, batch record
review, investigations, production support, training, and compliance initiatives.

1.化學系, 應用化學系,食品營養系,醫藥化學系畢業者佳
2.具藥廠相關經驗者佳

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校
2.執行實驗室設備3Q
3.研擬審查藥典相關產品規格及分析測試，建立藥典規格
4.操作化學分析儀器進行分析，協助產品放行

語文條件
英文(聽:精通、說:精通、讀:精通、寫:精通)
擅長工具
Excel
Power BI
SAP

1.Responsible for procurement data analysis, cost tracking, and SAP S4 HANA system expertise.

2.Generate historical data reports across functions (Procurement, Finance, SAP, HANA, CAR) and develop Power BI reports, dashboards, and KPI scorecards.

3.Assist in spending analysis, procurement strategy setup, and preparation of reports (cost savings, KPI tracking, process flow).

4.Ensure systematic purchasing delivery tracking to prevent material shortages.

5.Enhance cost analysis reports and maintain analytical tools (templates, configurator).

6.Act as SAP power user/SME, manage BPM across all ERP systems, and design methodologies and project documentation.

7.Prepare reports, plans, budgets, and handle documentation and administrative tasks.

8.Required to work at the Nantou site at least 2-3 days per week.

■ Familiarity with Microsoft platform development and Agile methodologies
■ Experience in project management and IT service management (ERP, CRM)
■ Strong analytical and problem-solving skills
■ Excellent technical abilities, including experience with database management and project management software
■ Knowledge of enterprise application integration software (net core 8, C#, Vue.js, SQL Server)
■ Understanding of software development and web technologies
■ BS/BA in Computer Science, Engineering or a related field
※ 歡迎緯育TibaMe學員投遞履歷

1.Lead and oversee the development and enhancement of Commercial-off-the-Shelf applications.
2.Work with business and IT stakeholders to prioritize, plan, and schedule application development requests while guiding the development team.
3.Ensure application availability, performance, and ownership of incidents and release management.
4.Deliver quality applications with controlled change management and provide project updates to leadership.
5.Collaborate with other discipline leaders to align solutions with business, technology, infrastructure, and security needs.
6.Oversee project work, including technical specifications and code reviews, to ensure adherence to standards.
7.Manage relationships with vendors, consultants, IT teams, and internal stakeholders.
8.Stay hands-on with technology, explore new innovations, and balance technical expertise with team management.

1. Expertise/familiar with infrastructure tools
2. Strong collaboration and communication skills needed to ensure satisfaction and work in cross-cultural teams and across geographies (US and APAC region countries)
3. Very good debugging skills with an ability to handle complexity
4. Experience in performance related topics and test-driven developments a plus point
5. Expertise in various technologies including ABAP, HANA and/or Object-oriented concepts is a plus

1. Support and facilitate business user's requirement to seamlessly running at corporate SAP system in the landscape via analyzing, designing, and developing.
2. Work closely with the team (other SAP developers, infrastructure & system teammates) to understand business needs and deliver features in good quality at timely manner.
3. Be capable of creating and assessing software architecture/designs with multiple stakeholders.
4. Manage overall change request and/or incident backlog for the owned topics and ensure the high quality of corrections and notes for the owned topic areas and of stable assist packages with no regressions.
5. Exhibit learning agility by quickly upskilling on new tasks and concepts.
6. Assist our business users during product deployment, critical operations, and system rollout via standard infrastructure, creating maintenance notes and documentation.
7. Will be providing presentations and workshops.

科系要求
生物學相關,藥學相關,醫學技術及檢驗相關
語文條件
英文(聽:中等、說:中等、讀:精通、寫:精通)

1.Evaluate and provide technical recommendations for CMC documentation and CTD dossiers from a regulatory perspective.
2.Interpret and address regulatory queries from clients and authorities, providing action plans, solutions, and scientific justifications.
3.Assess registration feasibility and develop global registration strategies for new R&D products.
4.Work with R&D, technical teams, and RA PM to overcome technical challenges and complete dossiers for product approval.
5.Ensure all regulatory documents meet authority requirements for export product registration.
6.Prepare and submit responses to regulatory deficiencies, ensuring compliance with authority expectations.
7.Monitor registration regulation updates and provide relevant information and training to the team.

- From the accounting, finance, or business administrative related fields
- Around 2 years of prior experience in external audit (big Four required), internal audit, internal controls, or risk management related fields.
- Good communication and problem-solving ability
- Ability to work independently and as part of a team
- Meticulous attention to detail with the ability to multi-task
- Project management experience is a plus
- Pharmaceutical or healthcare industry experience is a plus

1. Plan and execute internal audits and special projects to evaluate the risks and the effectiveness of related controls.
2. Prepare reports for each engagement and communicate audit observations with corporate, regional, and local management. Apply problem solving skills to issues and provide practical and constructive recommendations.
3. Develop credibility and trust with operating functions to value-add internal controls and management.
4. Monitor changes in Company policies and procedures to align with the applicable Regulations, Standards, and industry practices.