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職責Responsibilities：
- 負責企業(yè)質量管理體系的建立、維護和持續(xù)改進，確保符合中國 GSP及總部合規(guī)要求。
Responsible for the establishment, maintenance and continuous improvement of the enterprise's quality management system to ensure compliance with Chinese GSP, and headquarters' compliance requirements.
- 擔任企業(yè)質量代表，應對藥監(jiān)部門檢查（如飛行檢查），協(xié)調處理質量事故及投訴。
Serve as the enterprise's quality representative, handle inspections by drug regulatory authorities (such as unannounced inspections), and coordinate the handling of quality incidents and complaints.
- 審核藥品采購、驗收、儲存、運輸等關鍵環(huán)節(jié)的合規(guī)性。
Review the compliance of key links such as drug procurement, acceptance, storage and transportation.
- 領導藥品年度報告、MAH 境內責任人體系等制度的執(zhí)行，確保與藥監(jiān)部門的溝通暢通。
Lead the implementation of systems such as the annual drug report and the MAH domestic responsible person system to ensure smooth communication with drug regulatory authorities.

任職要求Qualifications:
- 藥學、醫(yī)學或相關專業(yè)本科及以上學歷，持有中國執(zhí)業(yè)藥師資格證書。
Bachelor's degree or above in pharmacy, medicine or related fields, with a Chinese licensed pharmacist qualification certificate.
- 10年以上藥品質量管理經驗，5年以上管理崗位經驗，熟悉外資藥企合規(guī)體系優(yōu)先。
Over 10 years of experience in drug quality management, including at least 5 years in a management position. Familiarity with the compliance system of foreign-funded pharmaceutical enterprises is preferred.
- 精通 GSP 及國際藥品流通標準，具備應對審計的能力。
Proficient in GSP and international drug distribution standards, with the ability to handle audits.
- 優(yōu)秀的中英文書面及口頭表達能力。
Excellent written and oral communication skills in both Chinese and English.