SMQA for QC (小分子)

职责/Responsibilities

a) 监测并确保 QC 实验室内符合质量保证标准，确保所有活动符合药品生产质量管理规范 (GMP) 和适用法规。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.

b) 审核并批准实验室检测结果、分析程序和其他相关文件，以确保所有文件完整、准确且符合行业法规（FDA、EMA、ICH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, ICH, etc.).

c) 主动识别检测过程和实验室操作中的潜在风险，并领导调查（偏差/LIR等）和纠正/预防措施 (CAPA) 以缓解问题，确保始终符合合规性和质量标准。Proactively identify potential risks in testing processes and laboratory operations, and lead investigations (Deviation/LIR, etc.) and corrective/preventive actions (CAPA) to mitigate issues, ensuring compliance and quality standards are consistently met.

d) 具有GMP管理体系下变更控制管理经验，熟悉分析方法、检验标准、设备设施、计算机化系统及实验室流程相关变更的风险评估、影响分析、实施跟踪和有效性确认。能够协调QA、QC及相关部门推进变更实施，确保变更符合法规要求、质量体系要求及业务需求。

Demonstrated experience in change control management within a GMP-regulated environment. Familiar with risk assessment, impact evaluation, implementation tracking, and effectiveness verification of changes related to analytical methods, testing specifications, laboratory processes, equipment, facilities, and computerized systems. Able to effectively coordinate cross-functional teams to ensure changes are implemented in compliance with regulatory and quality system requirements.

e) 监督并确保实验室检测方法的转移及验证活动，包括方法转移、理化测试、仪器分析以及相关文件等符合法规要求和行业最佳实践。Oversee and ensure that laboratory analytical method transfer and validation activities, including method transfer, physicochemical testing, instrumental analysis, and related document, which are conducted in compliance with regulatory requirements and industry best practices.

f) 准备并支持内部和外部审计和监管检查，确保完全遵守适用的监管要求和公司政策。Prepare for and support internal and external audits and regulatory inspections, ensuring full adherence to applicable regulatory requirements and company policies.

g) 与其他部门（包括质量控制团队、生产团队、项目管理团队、注册团队等）密切合作，以解决质量相关问题，并确保整个实验室和更广泛的业务部门的顺利运行。Work closely with other departments, including QC, production, project management and regulatory teams, to resolve quality-related issues and ensure smooth operations across the lab and wider business functions.

资质要求/Qualifications

a) 化学、生物化学、生物学、药学本科及本科以上学历。Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical.

b) 在GMP监管要求的制药实验室中，至少有3年的质量保证或质量控制经验。有临床后期或PPQ项目经验更佳。Minimum 3 years of experience in a Quality Assurance or Quality Control role within a GMP-regulated pharmaceutical laboratory. Experience with late-stage clinical development programs and/or Process Performance Qualification (PPQ) activities is highly preferred.

c) 在制药或生物技术行业中，对于原料药理化检测及仪器方面拥有丰富的经验。

Extensive experience in analytical testing of drug substances (APIs), including physicochemical, instrumental, and microbiological testing, gained within pharmaceutical or biotechnology environments.

d) 卓越的沟通能力（口头和书面），能够与不同的利益相关者合作互动。Excellent communication skills, both verbal and written, with the ability to interact with various stakeholders.

e) 精通使用质量管理软件、LIMS和其他实验室系统进行记录和跟踪。Proficient in using quality management software, LIMS, and other lab systems for documentation and tracking.