美時化學製藥股份有限公司

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.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. Manage 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. Provides leadership to assigned staff by performing the following: ◆ Leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals. ◆ Building effective teams that apply their diverse skills and perspectives to achieve common goals. ◆ Driving engagement and creating a climate where staff is motivated to do their best. 3. Oversees, manages, and ensures the successful day-to-day operations of Quality Assurance-Operation departments for the company. 4. Ensure the QA successfully performs batch disposition activities to meet specified timelines. 5. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 6. Establish meaningful goals and metrics for groups in conjunction with the Site Head of Quality, and manage the performance to those goals. 7. Interfacing with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required by the QA staff. 8. Communicating priorities and distributing work assignments to direct reports. Ensuring that all work performed by Staff is performed safely, with quality, and in a timely, compliant manner. 9. Leading and ensuring the group is leading and participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and processes as well as those on the shopfloor through the A on the Floor function. 10. Leading, managing, and/or participating in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensuring the group is doing the same as required. 11. Providing feedback and coaching in technical skill development, job performance, and career growth, and taking necessary disciplinary actions if necessary. Advocating for employees when required. 12. Ensuring the quality and compliant production and disposition of batches and the quality and compliant operation of all systems throughout the facility in accordance with schedule requirements. 13. GMP Supplier Oversight: ◆ Oversight of the GMP Vendor Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both Auditors and Vendors. ◆ Review 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 vendor audit responses and manage the review/editing cycle until responses are acceptable. ◆ Requesting documented evidence of closure when necessary and filing electronically and in hard copy. ◆ Updating CAPA trackers. 14. Quality Assurance Management: ◆ Documentation control (master batch record, specification & method). ◆ Batch record review and product disposition. ◆ Investigations, complaints, deviations, CAPAs, APRs. ◆ Production support. ◆ APRs, GMP training, and SOP review. ◆ Validation/qualification documentation review & approval. ◆ QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support, and drive compliance throughout the site. ◆ Departmental budget development and compliance. ◆ Regulatory and customer inspections management. ◆ Quality management review – quality board and related KPIs.

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

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. - Analytical Method Development: Perform analytical method development, formulation screening, finished product testing, stability study, dissolution testing, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage. Support NDA and ANDA submission. Support the complete drug development lifecycle management. 分析方法開- 主要職責包括以下內容: 在開發階段進行分析方法開發、配方篩選、成品測試、安定性研究、溶出度測試、原廠藥逆向工程、技術轉移和實驗室相關工作。協助NDA和ANDA查驗登記。協助完整的藥物開發生命週期管理。 - Method Validation: Perform analytical method validation, analytical method verification for drug substances, finished products, cleaning analytical methods. Conduct method transfer. Support raw material and stability analysis. Support NDA and ANDA submission. 方法驗證: 執行原料藥、成品、清潔分析方法的分析方法確校、分析方法確認。執行方法轉移。協助原料和安定性分析。協助NDA和ANDA查驗登記。 2. Train, lead, mentor and supervise team members in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with GMP, correct procedures, policies, and health and safety regulations. 在日常實驗室操作中，訓練、領導並監督團隊成員。協助相關部門和客戶按時完成專案。確保所有活動和分析均符合藥品良好製造規範、正確的程序、政策以及健康和安全法規。 3. Responsible and accountable for the quality and timeliness of the project deliverables, resource management, technical support for team members, and communication of the progress to the senior management. 對專案交付的品質和及時性，資源管理，團隊成員的技術協助以及與高級管理階層的進度溝通負責並承擔責任。 4. Manage and lead day-to-day operations with the team, including prioritization, task assignment, workload management, and risk management. 與團隊一起管理和領導日常運作，包括優先順序調整、任務分配、工作負荷管理和風險管理。 5. Adequately utilize and maintain analytical instruments/equipment. Diagnose and identify solutions to resolve analytical instrument issues. Perform calibration, qualification, and preventive maintenance. Support for procurement and qualification of new analytical instruments/software. 充分利用和維護分析儀器/設備。診斷和識別解決方案以解決分析儀器問題。執行校正、驗證和預防性維護。協助採購和驗證新的分析儀器/軟體。 6. Review the documents, electronic records. Prepare analytical protocols and reports, and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity. 審查文件、電子記錄。準備分析計畫書和報告以及化學製造管制文件。監控數據趨勢並協助缺失信件回覆。確保優良文件化規範和數據完整性。 7. Lead and support CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and GMP inspection。 協助變更管制、偏差調查、矯正預防措施、實驗室調查報告、標準操作程序準備、稽核。 8. Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks, and scan copies. 負責管理檢規、經過驗證的Excel工作表、已批准的報告（紙質和電子版）、筆記本和掃描副本。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 如適用，依據分配責任，維持化學實驗室運作皆符合藥品良好製造規範。 10. Transfer analytical method to Quality control, QP sites, and other receiving laboratories. 轉移分析方法到品質管制，QP所在地和其他接收實驗室。 11. Lead and guide laboratory management work, e.g., reference/working standard management, instrument management, laboratory area cleaning, reagents and solvents, and other supporting systems. 領導和指導實驗室管理工作，例如參考/工作標準管理、儀器管理、實驗室區域清潔、試劑和溶劑以及其他支援系統。 12. Stay informed with the latest industry trends, techniques, and best practices. 隨時了解最新的行業趨勢、技術和最佳實踐。 13. Perform literature search, patent landscape review, regulation comparison, review guidelines, read the pharmacopeias, technical document to understand the latest knowledge of the pharmaceutical industry. 進行文獻檢索、專利態勢審查、法規比較、審查指南、閱讀藥典和技術文檔，以了解製藥行業的最新知識。 14. Ensure the laboratory Capex management. Review & approval 0f URS, DQ, IQ, OQ, PQ & Vendor qualification. 確保實驗室資本支出管理。 審閱和批准 URS、DQ、IQ、OQ、PQ 和供應商資格。 15. Promptly complete work and tasks assigned by the supervisor 及時完成上級下達的工作和任務。 16. Motivate and empower team members. Conduct performance review and appraisal for team members. 激勵和授權團隊成員。執行績效審查和評價。 17. Engage with the team and manage the conflict, making sure individual employees into a cohesive team and complete the project milestone. 與團隊互動並管理衝突，確保員工個人成為一個有凝聚力的團隊並完成項目里程碑。

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. Provide Quality Assurance support and/or lead projects in line with Alvogen/Lotus guidelines, procedures, cGMP, and ISPE guidelines and regulations related to authoring, executing, reviewing, and approval of specifications and validation documentation as appropriate according to the Validation Life Cycle, including but not limited to: - Validation Plans/Protocols - User Requirement Specification (URS) - Risk Assessment (RA) - Functional Specification (FS) - Configuration Specification (CS) - Design Specification - Commissioning - DQ, IQ, OQ, PQ - Summary reports - Requirements Traceability Matrix (RTM) - Periodic Review, etc. 2. Liaise and coordinate with all departments and relevant key stakeholders (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT) in providing quality assurance support for the Validation program. 3. Communicate validation approaches and requirements during audits if applicable. 4. Facilitate a continuous improvement culture with all departments (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT). 5. Provide Quality Assurance support for technical problems that impact products and processes. 6. Provide Quality Assurance support in regards to computerized systems and collaborate with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedure. 7. Provide Quality Assurance support in regard to deviations/exceptions during qualification activities. 8. Assist in the development of training material for qualification activities. 9. Serve as a Subject Matter Expert to support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork. 10. Manage Validation contractors to complete on-site validation, if required. 11. Lead and participate in cross-functional teams as defined by the site management team. 12. Must be able to maintain a “big picture” perspective without losing sight of the details necessary to meet deliverables and deadlines. 13. Interpret Regulatory Authority regulations, guidelines, and policies. 14. Communicate and ensure compliance with Quality objectives, policies, and procedures.

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 function

1. To establish training curricula in accordance with requirement of manufacturing activities, including manufacturing technology, GMP concepts and other working guidelines. 依照製造活動之需求建立訓練課程，包含製造技術、GMP概念與相關工作規範。 2. To establish wide variety of training materials, including SOPs, training slide deck, training video, testing questions and training checking list. 建立各種類型之訓練教材，包含SOP、訓練簡報、訓練影片、課程考題與訓練檢核表。 3. To optimize the current training materials, including revision of SOP, updating of slide deck and editing of training video. 針對現有的訓練教材進行優化，包含SOP改版、簡報更新與訓練影片製作。 4. To conduct effective induction and orientation sessions. 執行有效的新進人員培訓課程。 5. To conduct training activities in accordance with the training program, including newcomer training, SOP training, on-the-job training (OJT), and training activities related to GMP production. 依照訓練計畫執行訓練活動，包含新人訓練、SOP訓練、OJT與GMP生產相關之訓練活動。 6. Compile training document records and save them to training management system and assist in maintaining the training curricula in the training system. 彙整訓練文件紀錄保存至訓練管理系統並且協助維護訓練系統之訓練課程內容。 7. Other works assigned by manager. 其它主管交辦事項。

1.負責相關專案工程執行及能獨立作業充份了解每個廠務系統做好維護作業。 2.配合執行溫度及濕度均勻度測試。 3.負責供應系統: 空調系統、冰水主機、純水、CDA運轉及維護保養,以及緊急搶修、管理外包商執行細項，並針對現況提出良好的改善方案。

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。

※※※擴大徵才，工廠提升計畫完工，製藥產線擴大生產規模※※※ 依廠內標準作業程序和現行GMP規範，按排程和製造批次執行產品製造，工作內容包含： 1. 負責執行產品生產相關工作 2. 負責執行產品之製造 3. 負責生產進度及狀況，確實填寫批次記錄及相關表單 4. 執行設備及工作環境清潔及維護 5. 製程設備操作 (混和、打錠、造粒、充填、熔膠、壓丸、定型乾燥等)及相關GMP文件記錄填寫 6. 包裝機台操作(片裝、瓶裝、盒裝、裝箱等)及相關GMP文件記錄紀錄填寫 7. 其他主管交辦事項 加入我們的美時製藥產線團隊，讓您的技術熱情得到最大發揮！ 您將獲得製藥工藝和高品質生產技術的完善訓練及升遷制度，立即加入我們，美時是您製藥成就發展之路的唯一選擇！

1. Provide annual demand plan according to annual sales forecast and new product introduction project progress. 依據年度銷售預測與新產品上市專案，提供年度需求計畫 2. Organize monthly sales forecast and new launch product requirement into demand plan, upload into ERP and plan the master schedule (delivery plan). 依據每月銷售預測與研發需求，整理成需求計畫並匯入ERP，以排定主排程計畫 3. Maintain reasonable inventory level and set up appropriate buffer stock to balance the supply chain delivery and inventory goals. 建立合理的庫存水準，並維持適當的安全庫存 4. Track monthly potential out of stock items, prevent stock-out risks in market, and make sure customer service level and on-time delivery meet targets. 追蹤每月可能缺貨項目，並確保市場無缺貨危機，以達成高客戶服務及準時交貨水準 5. Host and hold monthly pre-S&OP and S&OP meeting with sales and Marketing, Business Development and NPI department. 主持每月Pre-S&OP及S&OP會議，並與行銷、事業開發、新產品上市部門確認市場需求計畫 6. Track domestic demand forecast and sales/ B2B order progress to ensure the supply schedule meet customer requirement. 追蹤內銷市場預測需求及實際銷售狀況/ B2B訂單進度，確保供給計劃符合客戶要求 7. Continuously look for opportunities to improve the demand planning process, dissecting forecast errors and rectifying as needed to meet established forecasting accuracy goals. 持續改善需求計畫流程，並改進銷售預測偏差，以維持高銷售預測準確性 8. Coordinate local master data in ERP and ensure data integrity. 維護ERP主檔案，並確保資料完整性 9. Track new product launch status and ensure launch timeline meet target. 追蹤新產品上市進度，以符合預計上市時程 10. Issue purchasing requisition and maintain delivery status for domestic and global toll, merchandise, subcontracted product to ensure on time delivery 採購並追蹤委製及外購產品的交貨進度，確保達成準時交貨時程 11. Intradepartmental communication and coordination and assisting in completing work assigned by superior. 跨部門工作之溝通與協調，協助與配合完成上級交辦之工作。

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.

Job Summary: This position is based at Lotus Taipei office and involves working closely with the local RA teams to manage the registration for in-licensing products. The role is accountable for RA experiences in new submissions and life-cycle management across both Asia and Southeast Asia. English communicative skills in spoken and writing clearly, concisely, and effectively are essential. This role offers exposure to an international RA environment and facilitates the development of expertise in regulatory affairs and project management. 1. Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through national procedures in the APAC region. 2. Coordinating the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects. 3. Providing support for samples preparation and dispatch, when necessary. 4. Ensuring all the additional processes relating national submissions (pre-reviews, DMF, PMF and GMP accreditation etc.) are submitted on time and those submissions/approval processes do not delay drug registration. 5. Communicating with third parties in order to expedite submissions and ensure regulatory compliance. 6. Ensuring all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects as well as the ones related to PI for all the ongoing procedures. 7. Ensuring that accurate and complete information is timely provided to other departments/third parties and inform the relevant functions on the status and progress of the assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur. 8. Controlling costs and ensure proper internal evaluation and approval for each cost before it is being generated. 9. Providing support for documents and samples preparation for tenders and legal activities related to patents. 10. Coordinating the arrangements for inspections requested by the local authorities. 11. Maintaining the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions. 12. Ensuring that the internal regulatory database applicable trackers and SharePoint locations are kept up-to-date.

Overall Objectives Safety Officer, under the leadership of Lotus PVO (Pharmacovigilance Operations) Head, is responsible for execution of PVO activities in accordance with the Lotus pharmacovigilance quality system and local pharmacovigilance requirements. General Duties • Participates in or conduct daily PVO activities assigned by PVO Head • Maintains an accurate and comprehensive list of the Lotus products which are subject to pharmacovigilance activities by monthly alignment with the Regulatory Affairs teams • Coordinates with Local PV Offices (LPOs), PV CROs and partners or vendors regularly for PV activities • Monitors and tracks the PV activities performed by the stakeholders/LPOs, including, but not limited to: • Screening of local legislation and regulatory safety announcements, screening of local scientific journals for relevant safety information, as required • Maintenance of PV trackers (Individual Case Reports, Medical Inquiry and Product Quality Complaint, Aggregate Report tracker, Risk Management tracker, Safety Data Exchange Agreement tracker) • Updating of PSMF (Pharmacovigilance system master file) and relevant annexes as required • Reviews Individual Case Safety Reports (ICSR) and Medical Inquiries (MIs), as needed • Is aware of the risk management plans approved in their territory and of the risk minimization measures implemented. Assists in ensuring that the required activities are performed and tracked • Assist with the preparation and review of aggregate safety update report (PSUR, PBRER etc.) • Is aware of local safety concerns and supports the signal detection activities by reviewing the outcome of the screening of the local PV legislation and safety announcement, as required • Maintains and files the PV documents filed in the PVO specific folders (hard copy, where required and soft copy) • Coordinates for translation of PV related documents, when required • Tracks received adverse event, MI and PQC. Participates in reconciliation of PV activities between the Local PV Offices (LPOs) and PV CROs or partners or verifies that reconciliation activities are performed as per requirement • Supports in submission of relevant ICSRs received to competent authority within deadline • Participates in regular meetings with PVO and PV CRO as required and in-charge of MOM • Consults PVO Head for any issues or uncertainties relating to pharmacovigilance activities • Communicates with LPOs, PV CRO and other external PV vendors • Informs PVO when contacted regarding agreement involving pharmacovigilance obligations • Supports during audits and inspections • Trains on and applies the Lotus pharmacovigilance SOPs and the applicable PV related regulation • Stays current on the local PV legislation in the Lotus MA countries • Is involved during the development of Lotus pharmacovigilance SOPs • Ensures that all relevant employees in the LPOs receive basic pharmacovigilance training and that training is recorded and archived appropriately • Performs any other PV related activities assigned by the line manager (PVO Head) • Liaise with the stakeholder department or other internal departments.

1. Provide leadership and manage the work activities of direct reports in the area of application development for Commercial-off-the-Shelf applications that includes new solutions and enhancement of existing applications 2. Collaborate with business and key IT stakeholders to plan, prioritize, and schedule applications development and enhancement requests, while providing direction and guidance to the applications development staff 3. Accountable for availability and performance of applications portfolio, including ownership of incidents and release management 4. Drives stakeholder satisfaction by delivering quality applications and support with controlled and planned change management and communicate project status to various levels of management 5. Partner with leaders of other disciplines to ensure proposed solutions align with information, technology, infrastructure, business and security architectures 6. Provide oversight in standards adherence through reviews of project work including detailed technical specifications and application code 7. Proven experience in managing relationships with vendors/consultants, IT teams and internal stakeholders 8. A passion for all things tech and a drive to experiment with new technologies to see where they can benefit the business and staying hands-on technical as well as wearing that team management hat

※※※ 感謝您對美時製藥的關注 ※※※ ★欲了解目前開放的工作機會，請參考 104 人力銀行上的各職缺詳細說明★ 此為集中媒合專區，只要對Lotus美時製藥職缺有興趣，歡迎持身心障礙手冊朋友主動投遞履歷，應徵者請以104系統投遞履歷，並請在個人履歷上註明「欲應徵的職務」，若適合職務需求將有專人根據個人專長進行職缺媒合，並主動聯繫通知後續面試安排。 如未接獲通知，表示暫無適合的職缺，恕不另行通知。參與面試者，面試時需檢核身心障礙證明文件。 ◆歡迎推薦身心障礙朋友投遞本公司履歷◆

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.