職責/Responsibilities l 監(jiān)測并確保 QC 實驗室內(nèi)符合質(zhì)量保證標準，確保所有活動符合藥品生產(chǎn)質(zhì)量管理規(guī)范 (GMP) 和適用法規(guī)。 Monitor and ensure compliance with quality assurance standards within the QC lab, ensuring that all activities comply with Good Manufacturing Practices (GMP) and applicable regulations. l 審核并批準實驗室檢測結果、分析程序和其他相關文件，以確保所有文件完整、準確且符合行業(yè)法規(guī)（FDA、歐洲藥品管理局、ISO等）。 Review and approve lab test results, analytical procedures, and other relevant documentation to ensure all are complete, accurate, and compliant with industry regulations (FDA, EMA, ISO, etc.). l 準備并支持內(nèi)部和外部審計和監(jiān)管檢查，確保完全遵守適用的監(jiān)管要求和公司政策。 Prepare for and support internal and external audits and regulatory inspections, ensuring full adherence to applicable regulatory requirements and company policies. l 主動識別檢測過程和實驗室操作中的潛在風險，并領導調(diào)查和糾正/預防措施 (CAPA) 以緩解問題，確保始終符合合規(guī)性和質(zhì)量標準。 Proactively identify potential risks in testing processes and laboratory operations, and lead investigations and corrective/preventive actions (CAPA) to mitigate issues, ensuring compliance and quality standards are consistently met. l 監(jiān)督并確保實驗室檢測方法的適當驗證，包括生物學、微生物學和受體檢測，符合法規(guī)要求和行業(yè)最佳實踐。 Oversee and ensure proper validation of laboratory test methods, including biologic, microbiology, and recipient testing in alignment with regulatory requirements and industry best practices. l 與其他部門（包括QA、生產(chǎn)和監(jiān)管團隊）密切合作，以解決質(zhì)量相關問題，并確保整個實驗室和更廣泛業(yè)務部門的的順利運行。 Work closely with other departments, including QA, production, and regulatory teams, to resolve quality-related issues and ensure smooth operations across the lab and wider business functions. 資質(zhì)要求/Qualifications: l 化學、生物化學、生物學、藥學本科及本科以上學歷。 Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. l 在GMP監(jiān)管要求的制藥實驗室中，至少有3年的質(zhì)量保證或質(zhì)量控制經(jīng)驗。 Minimum 3 years of experience in a Quality Assurance or Quality Control role within a GMP-regulated pharmaceutical laboratory. l 在制藥或生物技術行業(yè)中，對于生物、微生物或化學檢測方面擁有豐富的經(jīng)驗。 Solid experience in biological ，microbiological or chemical testing within the pharmaceutical or biotechnology industry. l 卓越的溝通能力（口頭和書面），能夠與不同的利益相關者合作互動。 Excellent communication skills, both verbal and written, with the ability to interact with various stakeholders. l 精通使用質(zhì)量管理軟件、LIMS和其他實驗室系統(tǒng)進行記錄和跟蹤。 Proficient in using quality management software, LIMS, and other lab systems for documentation and tracking.