南投縣轉職工作機會，轉職跳槽推薦工作，提供履歷健診等強化服務|1111轉職專區-第275頁

秘書 Secretary
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資面議（經常性薪資達4萬元或以上）40000~40000元
工作內容 1. Coordinate schedule, including meetings, appointments, and travel to ensure smooth running 2. Screen and manage mails and documents, and communicate with other departments and staff 3. Prepare presentation decks, materials and meeting minutes, and attend meetings as requested 4. Prepare and manage correspondence, and summarize documents 5. Maintain confidentiality of sensitive information 6. Handle and process documentation and other administrative tasks 7. Prepare reports, plans, and budgets for meetings

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應徵

工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

(資深)品管專員(Sr.) QC Specialist (微生物Microbiology)
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資面議（經常性薪資達4萬元或以上）40000~40000元
工作內容 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.

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應徵

工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

SAP(資深)專員 SAP (Sr.) Specialist (ABAP)
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資面議（經常性薪資達4萬元或以上）40000~40000元
工作內容 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.

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工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

法規主任 Regulatory Affairs Section Lead
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資面議（經常性薪資達4萬元或以上）40000~40000元
工作內容 1. Organize regulatory information and track and control submissions, review and advise on submission strategy for compliance with regulatory filings. 2. Evaluate new proposed change from operation team and assessment impact and requirement on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues and RA team. 3. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 4. Represent Regulatory Affairs on project teams to ensure all regulatory requirements are met throughout the product lifecycle. 5. Regular update RA status in order to align with business objectives, deliver outstanding launches. 6. Keep closer communication with marketing team and related department proactively to get correct and immediate updates of our products. Need to ensure the variation not disturb the inventory. 7. Effective in working with multifunctional team and to fix complex matrices. Strong communication, interpersonal, organizational skills and problem solving skills. 8. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 9. Relocated in Nantou Operation Center for training for above 6months to a year.

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應徵

工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

品保專員 OQ Specialist (歡迎應屆畢業生加入)
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 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.

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工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

(資深)研發品保專員 (Sr.) DQA Specialist
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 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

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工作適配度－%

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6/6

(資深) 品保專員 (Sr.) QA Specialist, AP
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 1. Facilitate the Lotus disposition process including: -Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis. -Managing timelines and resources to ensure the disposition of material in accordance with Lotus‘ SOPs and within agreed timelines. 2. Support and ensures the successful day-to-day operations for the company. 3. Perform batch disposition activities in accordance with Lotus‘ SOPs and within agreed timelines. 4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner. 6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor functio

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應徵

工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

(資深)品管專員(Sr.) QC Specialist
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 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

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工作適配度－%

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6/6

法規(資深)專員 Regulatory Affairs (Sr.) Specialist
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 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.

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工作適配度－%

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品質系統經(副)理 Quality Systems (Assistant) Manager
企業名美時化學製藥股份有限公司
工作地點南投縣南投市
薪資月薪37000~0元
工作內容 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.

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應徵

工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

6/6

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