BORA PHARMACEUTICALS CO., LTD._保瑞藥業股份有限公司

*上班地點為台北保盛 (位於內湖保瑞藥業) *此職位入職後即有出差北美的行程安排 - 每月營運資料彙整與分析及管理報表編制(美國關係企業) - 董事會、工商登記、員工認股權及通報重大訊息予母公司(保瑞)等股務相關作業 - 支援財會部門作業(如收付款作業、月結及預算編製) - EGS窗口與母公司對接 - 各項專案規劃及推動執行 - 不定時編製或提供主管所需報表或文件 - 其他主管交代之事項

•新產品評估 •規劃協調新產品查驗登記策略、時程與執行。 •規劃產品上市後變更、展延案件之送件時程與策略 •藥品名稱之商標申請與維護 •監督整合規劃eCTD文件之產出 •解決其他部門之法規相關問題 •計劃與執行預算 •監督管理訓練屬員所屬事宜 •輸入藥品之查驗登記(藥品許可證、PMF、DMF) •審核出口國查驗登記所需文件 •藥品許可證生命週期維護：展延、上市後變更

Job Summary: We are seeking a strategic and globally minded C&B Manager to serve as the key lead for total rewards in Taiwan, working in close partnership with the Global Head of Total Rewards based in the United States. This role will be instrumental in implementing and adapting global total rewards strategies locally while ensuring alignment with Taiwan-specific practices, laws, and culture. The successful candidate will bring strong analytical capability, a collaborative mindset, and the ability to operate effectively in a dynamic, multicultural environment as the company continues to expand globally through acquisition and organic growth. Key Responsibilities: Compensation: • Implement and adapt global compensation frameworks within the Taiwan context. • Lead salary structure design, job grading, and compensation benchmarking aligned with global methodologies. • Analyze market trends and conduct compensation surveys to inform competitive pay positioning. • Manage annual compensation cycles (merit increases, bonuses, equity awards) in partnership with global team. • Provide input and support on executive compensation, sales incentives, and variable pay programs. • Partner with Finance and HRBPs to ensure compensation strategies are aligned with both business and budget priorities. Benefits: • Oversee the local delivery of global benefit strategies, while maintaining local competitiveness and compliance. • Collaborate with regional/global HR teams and external providers to manage and evaluate benefits offerings. • Support benefits harmonization across the growing enterprise as part of integration efforts. • Monitor emerging trends (e.g., mental health, DEI-focused benefits) and recommend enhancements aligned with global direction. Policy Shaping & Governance: • Support the implementation and local adaptation of global compensation and benefits policies. • Partner with Legal, Compliance, and HR to ensure compliance with local labor laws, tax regulations, and data privacy. • Balance global consistency with local flexibility to ensure fairness, equity, and practicality. • Serve as a trusted advisor to senior leadership and HRBPs on policy interpretation and best practices. • Contribute to the development of global mobility, relocation, and remote work policies with regional relevance. Analytics & Technology: • Leverage global and local data to assess program effectiveness and inform decision-making. • Maintain or contribute to the management of compensation tools and platforms (e.g., Workday, 104, Willis Towers Watson, Mercer). • Prepare dashboards and reports for internal stakeholders, ensuring accuracy and insight-driven recommendations. ' Global Collaboration & Stakeholder Management: • Serve as the primary Taiwan-based partner to the Global Head of Total Rewards and the broader global Total Rewards team. • Ensure effective two-way communication between global and local teams. • Actively contribute to global projects, frameworks, and initiatives while representing Taiwan-specific insights and needs. • Collaborate across regions to support harmonization, integration, and the development of scalable C&B solutions. Language & Communication Requirements: • Fluency in English and Mandarin required (spoken and written). • Must be able to work and communicate effectively with English-speaking colleagues, including the direct manager based in the United States. • Comfortable operating in a multicultural, multi-time-zone environment.

We are seeking a proactive and experienced HR Business Partner to join our team at the Luzhu manufacturing site in Taoyuan. This role acts as a strategic HR partner to factory leadership, driving key human resources initiatives to support business operations, foster a positive employee experience, and ensure compliance. The ideal candidate brings strong experience in employee relations, talent management, and HR operations within a manufacturing or industrial environment. Business Partnering -Collaborate with plant leadership to understand operational goals and provide HR strategies to support them. -Serve as the primary HR contact for factory managers, supervisors, and employees. -Lead HR initiatives aligned with production needs and organizational culture. Employee Relations & Engagement -Promote a positive work environment through effective employee relations practices. -Address and resolve employee concerns and disciplinary issues in compliance with labor laws and internal policies. -Support employee engagement efforts, including surveys, action planning, and communication. Talent Management & Development -Support recruitment efforts for hourly and salaried factory roles. -Partner with managers on onboarding, training, and career development for factory employees. -Lead talent reviews, performance management, and succession planning within the plant. Workforce Planning & HR Operations -Analyze workforce data to recommend staffing, shift planning, and productivity improvements. -Ensure accurate and timely HRIS data entry, timekeeping, and payroll support. -Support organizational changes, such as team restructuring or new line launches. Compliance & Health/Safety Support -Ensure HR practices comply with labor laws and occupational health and safety regulations. -Partner with EHS (Environmental, Health & Safety) on incident reporting and investigations. -Participate in audits and manage documentation for HR-related compliance.

1. 熟悉上櫃法規,及公告申報 2. 熟悉公開發行公司內控及相關規章辦法訂定 3. 財報及經營管理分析 4. SPO及員工認股 5. 銀行額度維護及轉投資事業之財務規劃 6. 配合專案事項 7. 工作地點: 台北/新竹

1.客戶訂單管理 A.每日訂單輸入及維護 B. 退貨處理 2.處理銷售後端之內部行政作業 A.客戶訂單修改/變更發票等相關事宜 B.處理物流異常出貨情形及後續追蹤 C.醫療單位採購網銷貨資訊輸入及驗收確認 D.經銷商佣金計算及請款 E.健保藥價/管製藥品申報作業 F.每日帳款核對每日業績報表彙整 3.客戶資料管理 A.客戶資料建檔及紙本歸檔 B.客戶信用額度之建立及維護 4.定期進行管制藥品申報及管制藥品簿冊製作 5.庫存管理/異動盤點/年終盤點 6.其他主管交辦事項

1. 機器維修能力(故障分析與排除) 2. 機器保養系統操作維護改善。 3. 部門工作計畫及相關專案之執行。 4. 自動化系統維護及提升系統效能 。

1.設定/組裝/拆解/清潔 製程設備：例如混合機、造粒機、打錠機及膠囊充填機。 2.調製藥品主成分及水溶液。 3.依據規劃排程執行製造生產。 4.依據優良製造規範及標準作業程序記錄生產活動於批次記錄。 5.執行主管交付之其他任務。 6.需配合輪班，早班:07:00~15:30,中班:15:00~23:30,夜班:23:00~07:30，現以早中班為主。 7.週休二日，休國定假日 9.Team Award獎金$2,000/月 10.輪班津貼/加班費另計/免費工作餐/超大停車場 工作地點: 保瑞藥業竹南廠(益邦製藥)

工作內容 1.組裝/拆解/清潔 製程設備：例如數粒機、鎖蓋機及說明書機。 2.依據規劃排程執行製造生產。 3.依據優良製造規範及標準作業程序記錄生產活動於批次記錄。 4.執行主管交付之其他任務。 5.需配合三班制輪班，現在主要以早班、中班為主，暫無夜班。 6.績效獎金/輪班津貼/加班另計 7.提供免費工作餐，提供汽/機車停車場。 工作地點: 苗栗縣竹南鎮竹南科學園區科東三路1號 (新竹科學園區竹南園區)，保瑞藥業竹南廠(益邦製藥)

工作內容 1 .執行例行微生物分析，包含原物料、RD分析方法確效、中間體、成品。 2. 執行非例行工作，包含分析方法轉移、確效、驗證、計劃書編訂、品質事件調查。 3. 共同維護實驗室運作。 4. 執行水質取樣，包含自來水、純水與注射用水。 5. 協助執行環境監控與中間體取樣。 6. 針對品質事件，需辨識問題、協助收集數據、繪製事件真相與提出有效的結論。 7. 遵循公司與部門制定之環境安全衛生規範，以及公司政策。 8. 維護儀器及實驗室環境，已符合cGMP之要求。 9. 其他主管交辦事項。 工作地點: 桃園市蘆竹區長安路一段80號，保瑞藥業桃園蘆竹廠(景德製藥)

工作內容 1. CDMO專案： (1) 參與CDMO客戶會議討論，並配合討論內容修改製程設計。 (2) CDMO專案技術轉移相關文件(protocol, report, and master batch records)之制定、教育訓練及執行。 (3) CDMO專案之預試驗、試製及GMP生產批 (Lab-scale & Submission/Commercial batch scale)，並執行廠內教育訓練。 (4) 料號管理、原物料請購及庫存管理。 (5) 專案進度追蹤及其他因異動而進行之即時性調整。 2. 製程相關驗證確效作業： (1) 製程設備之性能驗證計畫書及報告書之制訂及審閱、協調相關部門依計畫書內容執行及分析結果，並於執行前安排教育訓練。 (2) 確效主計畫書之維護及更新。 (3) 製程確效、清潔確效、無菌製程模擬確效 (Aseptic process simulation; media fill)及其他。 (4) 驗證確效排程及進度管理。 3. 市售產品trouble shooting： (1) 市售產品發生異常事件時，協助品質部門執行相關技術性之調查。 (2) 市售產品安定性數據發生異常時，經調查後依規定進行處方或製程優化。 4. 部門行政事務： (1) 請購清冊及固資清冊管理。 (2) 主管交辦事項。 工作地點: 桃園市蘆竹區長安路一段80號，保瑞藥業桃園蘆竹廠(景德製藥)

工作內容 1. CDMO專案： (1) 參與CDMO客戶會議討論，並配合討論內容修改製程設計。 (2) CDMO專案技術轉移相關文件(protocol, report, and master batch records)之制定、教育訓練及執行。 (3) CDMO專案之預試驗、試製及GMP生產批 (Lab-scale & Submission/Commercial batch scale)，並執行廠內教育訓練。 (4) 料號管理、原物料請購及庫存管理。 (5) 專案進度追蹤及其他因異動而進行之即時性調整。 2. 製程相關驗證確效作業： (1) 製程設備之性能驗證計畫書及報告書之制訂及審閱、協調相關部門依計畫書內容執行及分析結果，並於執行前安排教育訓練。 (2) 確效主計畫書之維護及更新。 (3) 製程確效、清潔確效、無菌製程模擬確效 (Aseptic process simulation; media fill)及其他。 (4) 驗證確效排程及進度管理。 3. 市售產品trouble shooting： (1) 市售產品發生異常事件時，協助品質部門執行相關技術性之調查。 (2) 市售產品安定性數據發生異常時，經調查後依規定進行處方或製程優化。 4. 部門行政事務： (1) 請購清冊及固資清冊管理。 (2) 主管交辦事項。 工作地點: 桃園市蘆竹區長安路一段80號，保瑞藥業桃園蘆竹廠(景德製藥)

1. GMP/客戶查廠相關活動；校正及教育訓練的相關文件管理與執行。 2. 配合生產作業，安排與調整設備維修作業。 3. 負責各項委外修繕工程的監督與管理。 4. 提供穩定的公用系統。 5. 廠內修繕作業。 6. 緊急異常處理。 7. 上級交辦任務。 工作地點:桃園市蘆竹區長安路一段80號，保瑞藥業桃園蘆竹廠(景德製藥)

To perform independently one or a limited number of specific functions within QA, the specific QA function could be: Job description: Under management’s supervision to complete the assigned jobs independently for maintaining of the quality systems, including documentation system, training program, change control system, internal audit, regulatory inspection, supplier quality management, computerized system, regulatory intelligence, distribution management, investigation and CAPA system, product complaint, annual product review (APR) and annual report (AR), quality control alert limit (QCAL), cleaning validation (CV), and quality improvement project. Location: The place of work is in Luzhu, Taoyuan City. The company is Bora Pharmaceutical Zhunan Site(景德製藥)

To perform independently one or a limited number of specific functions within QA, the specific QA function could be: Job description: 1、Create and/or revise controlled documents, and ensure relevant trainings are completed in a timely manner through a robust change control process. 2、Plan, execute and follow up on internal audit and external audit programs to assure conformance with cGMPs. 3、Coordinate, accompany, and follow up Regulatory Authorities GMP inspection, PAI, and Client audit. Ensure procedure compliance by managing regulatory updates and implementation. 4、Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system. 5、Ensure Bora GDP procedures are established, followed, and executed appropriately in compliance with Current Good Distribution Practices (cGDPs) 6、Participate, facilitate, and manage samples for analysis; ensuring correct and timely sample collection and delivery. 7、Collect, compile, and review annual product review document. 8、Other assigned tasks Location: The place of work is in Luzhu, Taoyuan City. The company is Bora Pharmaceutical Zhunan Site(景德製藥)

To perform independently one or a limited number of specific functions within QA, the specific QA function could be: Job description: 1、Create and/or revise controlled documents, and ensure relevant trainings are completed in a timely manner through a robust change control process. 2、Plan, execute and follow up on internal audit and external audit programs to assure conformance with cGMPs. 3、Coordinate, accompany, and follow up Regulatory Authorities GMP inspection, PAI, and Client audit. Ensure procedure compliance by managing regulatory updates and implementation. 4、Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system. 5、Ensure Bora GDP procedures are established, followed, and executed appropriately in compliance with Current Good Distribution Practices (cGDPs) 6、Participate, facilitate, and review investigations of deviation, laboratory investigations and product complaint and relevant CAPAs to address the identified root cause(s). 7、Collect, compile, and review annual product review document. 8、Other assigned tasks Location: The place of work is in Luzhu, Taoyuan City. The company is Bora Pharmaceutical Zhunan Site(景德製藥)

The Specialist is mainly responsible for laboratory experiments executions, Lab equipment calibrations and preventive maintenance, preparation and/or revision QC relevant SOPs/SQARs/reports, lab control activities and compendia update related activities. Be able to host project activity or subject that may enhance the lab operations in quality and efficiency. • Performs QC Lab activities by following relevant present SOPs. • Prepares and revises QC relevant SOPs, associated training materials. • Prepares reagents that are to be used for analysis. Standardizes volumetric solutions by using standard written methods at specified intervals. • Analyses products, raw materials, packaging materials and stability samples according to laid down procedures in testing methods. • Records analytical data and results in notebooks, logbooks, Specification and Quality Assurance Report and laboratory analysis forms accurately. Records results in a trending monitor perspective. • Performs calibration and preventive maintenance activities of Lab equipment, in accordance with set methods and procedures. • Validate/Verify new analytical method for the characterization and quality control of active pharmaceutical ingredients, intermediates, excipients and drug products. • Perform the analytical testing for technical transfer projects or any requirement. • Reports malfunctioning equipment to Laboratory Supervisors or deputies for repair. • Alerts Laboratory Supervisors or deputies verbally in the event of any result not meeting specification or of any questionable results generated. • Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to Laboratory Supervisors or deputies. • Records expiry dates of analytical reagents developed in-house by noting the expiry date on container or document. • Handles and disposes dangerous materials, such as arsenic, cyanide, and concentrated acids, in accordance with standard safety practices. • Records regulated toxic controlled chemicals usage and disposition in accordance with standard predetermined procedures. • Maintains neatness of laboratory that following the concept of 6S – Sort, Set in order, Shine, Standardize, Sustain, and Safety. • Supports investigative testing and investigation activities. • Supports the compendia update and regarding assessment report preparation activities. • Perform in a continuous improvement attitude to meet the predetermined KPI. • Follows the training program schedule to complete the directed training courses. • Completes delegated tasks by the agreed completion date and treats as commitment. • Attends weekly laboratory meetings or delegated meetings. • Prepares and revises test methods. • Prepare and revise relevant technical reports. • Other duties as assigned by supervisors or company Location: The place of work is in Luzhu, Taoyuan City. The company is Bora Pharmaceutical Zhunan Site(景德製藥)

工作內容 1. 負責眼藥水、眼藥膏之調配、生產及產線維護。 2. 完成生產作業相關品質需求。 3. 機動性協助(包裝作業、包材領料)。 4. 其它主管交辦事項。 工作地點:桃園市蘆竹區長安路一段80號保瑞藥業桃園蘆竹廠(景德製藥)

• Perform assigned QC work, including routine and non- routine, independently The non-routine work may include method transfer/verificati on/ validation , protocol driven study, or investigations. • Trouble-shooting capability for QC technologies . • Assist in reviewing QC documents including notebooks, datasheets, experimental records, and logbooks • Provide guidance to specialists and lab technicians as assigned • Check the preparations of reagent, volumetric solutions, and test solutions • Perform method verification/ quali ficati on/ validation as required . • Assist in preparing SOP, protocol trai ning, and assigned analytical works

Job description: 1. Ensure change control system is robust and routed in a timely manner. Plan, execute and follow up on internal audit program to assure conformance with 2. Current Good Manufacturing Practices (cGMPs). 3. Coordinate, accompany and follow up Regulatory Authorities GMP inspection, PAI for new product and Third Party Audits by Customers. 4. Perform supplier qualification and maintenance 5. Manage the regulatory updates, implementation and compliance related procedures. 6. Participate, facilitate and review investigations of deviation, laboratory investigations and product complaint. Propose, review and implement corrective and preventive actions to address the identified root cause(s). 7. Collect, compile, review annual product review document. Maintain and provide statistics support of QCAL. 8. Support cleaning validation tasks. 9. Support and execute QIP fo for site innovation, improvement and enhancement of regulatory requirement 10.Other tasks as assigned by the company. Location: The place of work is in Zhunan Town, Miaoli County. The company is Bora Pharmaceutical Zhunan Site(益邦製藥)