轉職熱搜工作

1.製程技術與新產品開發、量產導入 2.監控製程品質及良率改善 3.製程能力提昇、測試實驗規劃與結果分析 4.降低生產成本，優化製程品質及參數 5.遵守SOP流程，處理及排除異常 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––- *理工相關科系畢 *積極主動、邏輯清晰能力佳 *具備溝通協調能力佳

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. 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. 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.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

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. Establish analytical methods of microbial and execute method validation to ensure analytical method accuracy. 2. Issue blank test report for conduct raw material/package material, semi- product/product and stability analysis, sampling and records, to ensure product quality meets PIC/S GMP requirements. 3. Review of project plans and analysis result reports, inspection/test reports, and SOPs. 4. Conduct test on water for production, Total organic Carbon of water system in laboratory systems and microbial test to ensure the quality of the water. 5. Conduct preparations of growth mediums and potency and growth tests of growth mediums to ensure microbial test run smoothly. 6. Conduct bacterial sub-culturing ,culturing, identification and counts to ensure microbial tests run smoothly. 7. Conduct environmental monitoring of production zones A,B and C(bacterial test on air conditioning system to ensure the conditions of production environment meets GMP requirements. 8. Conduct cleaning and maintenance of all instruments and equipment, calibrations/validations and sort yearly assessment reports to maintain normal usage of instruments and equipment. 9. Perform self-inspections or internal audits as required by the audit schedule.