成大專區

主要工作內容： 1. 拆圖、零件用量表、成本分析表 2. 產品機構驗證與改善 3. 產品功性能/可靠度驗證 4. 技術文件規劃與導入 5. 主管交辦事項 *.略懂模具製作 *.懂沖壓,塑膠,壓鑄,粉末冶金,鑄造等成型技術者佳 *.有機械加工經驗尤佳

徵求 【CNC車床/铣床加工技術員】 工作內容: 1.CNC車床/銑床工件上下料定位作業，並協助換模時準備刀具、治具。 2.以游標卡尺/檢具進行尺寸測量。 3.機台異常時反應狀況。 4.執行主管交辦事項。 5.需配合加/輪班。

現場機械維修 及 自動控制檢查維修 並可配合支援現場作業

具大貨車駕照 1.依路線別有不同班別 線路一：配送生鮮菇類至各果菜市場 線路二：至產地載回生鮮菇類 2.理貨及備貨作業 3.空苔、棧板回收及管理 4.主管交辦事項

協助製作原種.菌種菌母.栽培包接菌,及實驗室.菌母室.環境管控

1.會計.出納.記帳.核對進/銷貨帳物銷帳核對資料. 2.人事行政工作.總務採購.零用金支出. 3.現場出貨.盤點資料. 4.協助現場作業.

1.化驗工程人員提出之金針菇作雜菌物質、成分等分析並記錄觀測值結果 2.研究優良之植物品種，以提高植物產量並增進品質 3.於實驗室工作研究金針菇菌種. 4.庫房栽培巡視.

具小貨車駕照，會駕駛手排車 1.收發要運送的生鮮菇類；將貨品送到客戶手中 2.運送貨物並保護貨物的完整 3.協助或自行裝卸貨物 4.有責任感肯吃苦耐勞及肯學習 5.態度親切有禮，無不良嗜好 6.主管交辦事項

1.庫存管理作業 2.理貨、出貨作業 3.原料及成品出入庫作業 4.主管交辦事項 低溫作業 需具備堆高機證照（另加2000～3000元）

1.理貨、出貨作業 2.原料及成品出入庫作業 3.主管交辦事項 低溫作業，具備堆高機證照者，另有加給

1.負責洗、剝、削、切各種食材，以完成烹飪的前置工作。 2.協助測量食材容量、重量及備料。 3.具備調理技能。 4.主廚交辦事項。 * 此職務為朝九晚六班，非兩頭班或需要輪班，職務內容單純壓力小。 * 享有完整考核制度，視工作表現及能力調薪。

1.領料、倒料、接料 2.混料(會產生粉塵，易過敏者請自行斟酌) 3.機台與環境清潔 4.本職務需長期久站及搬運重物 5.視業務情況需配合加班 6.主管交辦事項 (生產線提供多元工作機會，面試將一併介紹，並分發合適職務。)

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.

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. Per Each planning cycle to organize monthly sales forecast into campaign demand plan/bulk plan for production planning team to calculate the capacity requirement, material procurement plan and form the master schedule. 2. Prepare required data, challenge, reviews to report in monthly Domestic/Export S&OP meeting; confirming market demand with CS and Marketing team in the meeting. 3. Track demand forecast and sales/B2B order progress to ensure the supply schedule meets customer requirement. 4. Track production, testing and release progress to ensure the shipment schedule is followed. 5. New product launches-Ensure that all activities are aligned and provide timely submission of net requirements and orders. 6. Trigger escalation process as necessary. Identify and address potential supply issues pro-actively. Inform sales & marketing team on the potential supply risk timely. Recording all delay root cause for each shipment. 7. As Supply planner coordinate with demand planner, who oversees domestic market product, to manage local CMO PO Placement to meet inventory requirement. SPOC, escalation to TPP representatives for domestic TW CMO. 8. Intradepartmental communication and coordination and assisting in completing work assigned by superior.

1. Develop analytical methods, perform analytical tests, and assist the RD team in screening formulations for the NDA and ANDA drug development. 制定分析方法，進行分析測試，並協助RD團隊篩選用於NDA和ANDA藥物開發的製劑。 2. Follow laboratory SOPs and ensure GMP compliance. 遵循實驗室SOPs並確保符合GMP規範 3. Prepare technical documents and review data for the R&D projects and drug submission. 為研發專案和藥物開發準備技術文件並審查數據 4. Responsible for performing the R&D tasks and projects, such as analytical method development, method validation, formulation screening, raw material tests, finished product release, stability study, and dissolution testing.負責執行研發任務及專案，例如分析方法開發、方法確效、配方篩選，原料測試、成品放行、安定性研究和溶出度測試。 5. Use and maintain analytical instruments, GC, HPLC, UPLC,LC-MS Dissolution Tester, Titrator, Particle size analyzer, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues. 使用和維護分析儀器，GC，HPLC，UPLC，LC-MS溶出度測試儀，滴定儀，粒徑分析儀等。研究，診斷，故障排除和識別解決方案以解決分析儀器問題。 6. Train, lead, and supervise junior analysts in day-to-day laboratory opera

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.

1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective. 2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification. 3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products. 4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval. 5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority‘s requirements. 6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements. 7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.

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.

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.