溫士頓醫藥股份有限公司

1. 品質目標訂定、落實、監督與改進。 2. 領導並培訓品質控制團隊，提升團隊專業素養與品質意識。 3. GMP(藥品優良製造規範)、GDP (藥品優良運銷規範)文件之制定、更新、管理、記錄等相關業務。 4. 執行內部查核、接受外部查核，並依查核結果執行矯正及預防措施。 5. 規劃與建立品質檢驗和記錄系統，標準化品保系統流程。 6. 品質相關教育訓練。 7. 與利益相關方進行有效溝通協調，確保品保管理標準能被順利執行與落實。 8. 文件簽核、年度計畫跟催及管理。 9. 主管交辦事項。 歡迎加入我們，成為品保主管的一份子，共同打造高品質的藥品、保健食品及藥妝品，讓我們的產品成為消費者的信賴選擇！立即投遞履歷，期待您的到來！

1. Prepare and Submit Regulatory Documentation: Compile, review, and submit high-quality regulatory applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and Marketing Authorization Applications (MAA), to regulatory authorities. 2. Liaise with Regulatory Authorities: Act as the primary point of contact with regulatory agencies, responding to inquiries, providing additional data, negotiating requirements, and facilitating timely approvals or resolutions. 3. Monitor and Interpret Regulatory Changes: Continuously track updates in pharmaceutical regulations, policies, and industry trends, interpreting their impact and advising internal stakeholders (e.g., R&D, legal, and marketing teams) on necessary adjustments. 4. Ensure Product Compliance: Review and approve product labeling, packaging, advertising, and promotional materials to ensure alignment with regulatory requirements, including safety, efficacy, and legal standards. 5. Manage Regulatory Submissions Timeline: Oversee the preparation and submission process to meet deadlines, ensuring all documentation is accurate, complete, and submitted in accordance with agency specifications. 6. Maintain Regulatory Records: Organize, update, and archive regulatory documentation, correspondence, and approvals in a systematic manner to support audits, inspections, and future submissions. 7. Conduct Regulatory Risk Assessments: Identify potential regulatory risks or roadblocks in product development or marketing, proposing mitigation strategies to ensure compliance and project success. 8. Handle Post-Marketing Changes: Prepare and submit regulatory applications for post-marketing changes, such as updates to manufacturing processes, labeling revisions, or formulation changes, ensuring timely approval and compliance with regulatory standards.

1.統籌產品教育訓練並擔任講師 2.醫院招標進藥資料彙整與填寫 3.管制藥品管理及申報 4.新產品找尋及提案 5.專利及文獻檢索 6.市場行銷及藥學資料編輯 7.至醫療院所舉辦產品說明會 8.產品諮詢服務 9.醫學會參展事宜 10.主管交辦事項 藥師在藥廠職位的發展前景十分廣闊。 歡迎符合資格的申請人提交您的求職申請。