面試趣
Thank you for your interest in Lotus Pharmaceutical! ※※※ 感謝您對美時製藥的關注 ※※※在美時製藥,我們重視多元、尊重,致力於打造一個友善且包容的工作環境。本專區為「身心障礙/原住民人才就業媒合專區」,誠摯邀請對美時製藥有興趣的朋友踴躍投遞履歷。如果你對美時製藥有一點點好奇,或正在尋找一個適合自己的地方,都很歡迎你把履歷交給我們。在美時製藥,我們提供多元職務機會:有些需要專業背景與經驗(如技術、品保、化學分析、製造、行政等)也有一些,是讓環境更舒服、讓團隊更順利運作的重要支援性職務(如環境整理、庶務協助、清潔維護等)。無論您的專長、經驗或期待的工作型態,都歡迎您主動應徵,讓我們有機會更認識您。★ 欲了解目前開放職缺,歡迎參考公司官網或104 人力銀行各項職務說明 ★請透過公司官網或104 系統投遞履歷,並於履歷中註明「有興趣的職務類型或方向」,我們將依據您的背景與需求,協助進行合適的職務媒合,並由專人與您聯繫後續安排。若目前暫無適合機會,亦將納入人才資料庫,未來有合適職缺時優先聯繫。 面試當日將進行身心障礙證明文件之確認。 At Lotus Pharmaceutical, we value diversity and inclusion and are committed to creating a respectful, supportive, and inclusive workplace. This page is dedicated to our Talent Pool for Persons with Disabilities and Indigenous Candidates, and we warmly welcome individuals who are interested in exploring career opportunities with us. If you are even a little curious about Lotus Pharmaceutical, or are looking for a place where you can grow and belong, we encourage you to submit your resume. At Lotus Pharmaceutical, we offer a wide range of career opportunities.Some roles require specific professional backgrounds and expertise (such as technical, quality assurance, chemical analysis, manufacturing, and administrative roles),while others play an essential role in maintaining a comfortable and well-functioning work environment (such as facility support, general assistance, and cleaning services). Regardless of your background, experience, or preferred type of work,we welcome your application and look forward to getting to know you better. ★ To learn more about our current openings, please visit our job postings on the Lotus official website 104 Job Bank platform. ★ Please submit your application through Lotus official website or the 104 system and indicate your preferred job functions or areas of interest in your resume. Based on your background and preferences, we will help match you with suitable opportunities and contact you regarding next steps. If there are no suitable openings at the moment, your profile will be added to our talent pool, and we will reach out when relevant opportunities become available. Please note that verification of disability certification will be conducted on the day of the interview.
Responsibilities: 1. Assist supervisors in planning and implementing plant facilities, equipment, production operations, artwork management, and quality systems to enhance overall departmental performance. 2. Support the planning and execution of various projects. 3. Develop and完善 talent training programs and career development pathways. 4. Provide 100% pharmaceutical cGMP training. Qualifications: ● Demonstrates a positive work attitude, proactive learning mindset, and willingness to take on challenges. ● Proficient in English communication skills (TOEIC score above 750 preferred). ● Background in Engineering, Mechanical, Electrical, Pharmaceutical, Science, or Information-related fields, with a strong interest in developing a career in the manufacturing industry. * This position involves job rotation across Manufacturing, Engineering, Technical Services, Supply Chain, and Quality functions to develop future leadership talent for the company.
Responsibilities: 1. Responsible for executing relevant engineering projects and performing independent operations, with full understanding of each plant system to ensure proper maintenance. 2. Assist in conducting temperature and humidity uniformity tests. 3. Manage utility systems, including HVAC, chilled water systems, purified water, and CDA; perform operation, maintenance, emergency troubleshooting, and supervision of outsourced contractors, while proposing effective improvement solutions based on current conditions. Qualifications: Preferably holds certifications in Pressure Vessel Operation, Class B Boiler Operation, or related Electrical/Power certifications. Knowledge of plant utility systems, HVAC systems, and electrical systems. Experience in energy management for plant utility systems. Proficient in Microsoft Office and related software. Pharmaceutical industry experience or familiarity with GMP is a plus. Fresh graduates are welcome to apply.
Responsibilities: 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 (CoA). Manage timelines and resources to ensure material disposition in accordance with Lotus SOPs and agreed timelines. 2. Support and ensure the successful day-to-day operations of the company. 3. Perform batch disposition activities in accordance with Lotus SOPs and within agreed timelines. 4. Ensure timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 5. Ensure all work is performed safely, with high quality, and in a timely and compliant manner. 6. Participate in continuous improvement projects across the group and facility operations, including QA systems, processes, and shop floor activities through the QA on the Floor function. Qualifications: Minimum of 1 year hands-on experience operating HPLC. Educational background in Food Science, Pharmacy, Chemistry, or a related field.
Responsibilities: 1. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements. 2. Establish meaningful goals and metrics for groups in conjunction with the Function Lead, and manage the performance to those goals. 3. Ensure that all work is performed safely, with quality, and in a timely, compliant manner. 4. Manage and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensure the group is doing the same as required. 5. GMP Compliance Oversight: • Oversee the GMP Vendor Audit Schedule. Ensure vendor and auditor availability (internal/external/consultant), and confirm audit dates with both auditors and vendors. • Review supplier audit reports, ensuring they meet Lotus QA standards and are compliant with Lotus SOPs. • Request documented evidence of closure when necessary, and file both electronically and in hard copy. • Review vendor audit responses and manage the review/editing cycle until responses are acceptable. • Submit observation reports to vendors, communicate response timelines, and track them to ensure timely responses. • Submit observation reports to customers/regulatory bodies, communicate response timelines, and track to ensure timely responses. • Ensure regulatory compliance from both dossier and site operation perspectives. 6. Quality Assurance Management: • Documentation control (e.g., master batch record, specification, and method) • Investigations, complaints, deviations, CAPAs, APRs Qualifications: • Educational background in Pharmacy, Biotechnology, Medical Devices, Food Science, Engineering, or a related field. • Minimum of 5 years of experience in the pharmaceutical industry. • Experience in GMP management and participation in international regulatory inspections (e.g., US FDA, EMA, TFDA, ANVISA) is highly preferred.
Summary: The QA Senior Manager is responsible for leading a group of QA specialists focusing on management of deviations, CAPA, laboratory investigations, complaints and change controls. QA Senior Manager is also responsible for managing communications with external stakeholders with regard to the investigation handling and closure. Responsibilities: 1. Responsible for ensuring deviations, laboratory investigations and complaints are investigated in a timely manner and thoroughly to determine the root cause(s) and determine appropriate CAPAs with the area owners. 2. Provide oversight for the investigation lead training program. Conduct training and assess the participants to certify investigation lead(s). 3. Responsible for review and approval of change controls related to batch manufacturing, packaging, testing and release. 4. Responsible for managing communications with external stakeholders with regard to investigation handling and closure. This includes both written and verbal communication. 5. Collaborate with Quality Compliance, Quality Systems and Shopfloor Quality to meet GMP requirements. This includes participating in continuous improvement projects and supporting audits. 6. Manage costs within budget allocated to the team and be involved in budget planning for Quality function. 7. Coach team members on both technical and soft skills and work with them on their development plan. 8. Ensure inspection readiness and serve as the primary liaison with regulatory inspectors and/or clients during regulatory and customer audits. Qualifications: • With experience in US FDA, EMA, and TFDA inspection. • 8+ years' relevant work experience. • Highly organized with excellent attention to detail.
Job Description: 1. Develop and optimize analytical methods (HPLC, GC, IC, etc.) to support product process development and analytical method validation. 2. Perform laboratory equipment qualification (IQ/OQ/PQ; 3Q). 3. Prepare and review pharmacopeial product specifications and analytical testing requirements; establish pharmacopeial specifications. 4. Operate chemical analytical instruments to conduct testing and support product release activities. Qualifications: ● Bachelor’s degree in Chemistry, Applied Chemistry, Food Science and Nutrition, Pharmaceutical Chemistry, or a related field is preferred. ● Prior experience in the pharmaceutical industry is a plus. ● Hands-on experience with HPLC operation is required.
1. Utilizing strategic sourcing process to identify, negotiate and implement packaging materials, indirect materials, procurement initiatives to drive cost savings. 2. Align with sourcing team to provide local business requirements and market information to support effective collaborative regional strategy creation and execution 3. Partnering with RD / RA/ NPL, and other Functional groups (Executives, Quality, R&D, Regulatory Affairs, Finance, Legal, Engineering….) in discovery, contract negotiation, optimizing economic value, on-time delivery of product & services, cost management & reduction, supplier & partner risk mitigation, and scope of work development. 4. Develop and implement forward thinking procurement strategies to both optimize spending and minimize risk. 5. Creation of effective preferred supplier program and instillation of organizational discipline on onboarding new vendors. 6. Development of KPIs for strategic sourcing with cyclical delivery which drives continuous improvement. 7. The primary work location for this position can be based in Taipei or Taichung offices, in addition to the Nantou site. The incumbent is required to work on-site at the Nantou facility at least 1 to 2 days per month, subject to business needs. Interview Arrangement & Notes:Please prepare a 1–2 page presentation introducing yourself and highlighting your relevant work experience.The interview will be primarily conducted on-site at our Taichung office. Thank you for your preparation. We look forward to learning more about your background and experience.