職責(zé)Responsibilities: - 負(fù)責(zé)企業(yè)質(zhì)量管理體系的建立、維護(hù)和持續(xù)改進(jìn),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(dān)任企業(yè)質(zhì)量代表,應(yīng)對藥監(jiān)部門檢查(如飛行檢查),協(xié)調(diào)處理質(zhì)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(yàn)收、儲存、運(yùn)輸?shù)汝P(guān)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(lǐng)導(dǎo)藥品年度報告、MAH 境內(nèi)責(zé)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(xué)、醫(yī)學(xué)或相關(guān)專業(yè)本科及以上學(xué)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(zhì)量管理經(jīng)驗(yàn),5年以上管理崗位經(jīng)驗(yàn),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(biāo)準(zhǔn),具備應(yīng)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(dá)能力。 Excellent written and oral communication skills in both Chinese and English.