QA 专员

部门：质量保证部

Department：Quality Assurance

职位：HBST-QA 专员

Position：HBST-QA specialist

职级 / Level: specialist II

最低任职要求Minimum Requirement

教育程度/经验Education background/ Experience

1. 本科及以上学历，药学、药物分析、生物工程、制药工程或相关理工科专业。

Bachelor’s degree or above in pharmacy, pharmaceutical analysis, bioengineering, pharmaceutical engineering, or a related science or engineering discipline.

2. 具有3年以上药品生产或质量管理相关经验，个人条件优秀者可适当放宽。

At least 3 years of experience in pharmaceutical manufacturing or quality management; the experience requirement may be adjusted for highly qualified candidates.

3. 具备GMP质量体系相关工作经验，熟悉偏差、变更、CAPA、质量风险管理及文件管理等质量体系流程。

Hands-on experience with GMP quality systems and familiarity with quality processes including deviations, change control, CAPA, quality risk management, and document management.

4. 具有质量体系文件起草、修订、审核、周期性回顾及生命周期管理经验；具备体系数据统计、趋势分析、有效性回顾或持续改进相关经验者优先。

Experience in drafting, revising, reviewing, periodically reviewing, and managing the lifecycle of quality system documents; experience in quality system data analysis, trending, effectiveness review, or continuous improvement is preferred.

5. 了解GMP以及ICH、FDA、EMA等相关法规和指南。

Knowledge of GMP and relevant ICH, FDA, and EMA regulations and guidelines.

其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)

1. 具备良好的GMP和数据完整性意识，能够基于事实、数据和风险进行质量判断。

Good GMP and data integrity awareness, with the ability to make quality decisions based on facts, data, and risk.

2. 逻辑性强，具备良好的问题识别、分析和文件书写能力。

Strong logical thinking with good problem identification, analysis, and documentation skills.

3. 具备良好的跨部门沟通协调能力，能够推动问题整改和行动项闭环。

Good cross-functional communication and coordination skills, with the ability to drive remediation and action closure.

4. 具备良好的中英文阅读和书面表达能力；能够使用英语开展日常GMP文件工作者优先。

Good Chinese and English reading and writing skills; ability to work with routine GMP documentation in English is preferred.

工作职责JOB RESPONSIBILITY

1. 生产现场质量监控：对生产区域关键操作进行现场质量监督，确保相关活动按照批准的SOP及GMP要求执行；对关键步骤实施见证或复核，及时识别现场异常并推动规范记录和处置。

Manufacturing floor quality oversight: Provide QA oversight of critical manufacturing operations to ensure activities are performed in accordance with approved SOPs and GMP requirements; witness or verify critical steps, promptly identify on-floor abnormalities, and drive appropriate documentation and handling.

2. 现场质量风险管理：参与生产现场质量风险识别与评估，审核报警响应、记录、影响评估及必要的偏差升级，支持报警周期回顾、趋势识别和持续改进。

On-floor quality risk management: Participate in identification and assessment of manufacturing quality risks; review alarm responses, records, impact assessments, and deviation escalation when required; support periodic alarm review, trend identification, and continuous improvement.

3. 批记录及电子数据审核：审核生产批记录、相关电子数据及GMP记录，关注记录的准确性、完整性、及时性和可追溯性，并推动发现问题的澄清和闭环。

Batch record and electronic data review: Review manufacturing batch records, relevant electronic data, and GMP records for accuracy, completeness, timeliness, and traceability, and drive clarification and closure of identified issues.

4. 文件及体系管理：参与SOP、管理规程、表单及相关质量体系文件的起草、修订和审核，执行或支持文件周期性回顾、文件生命周期管理及培训管理，确保文件持续适用并与实际操作保持一致。

Document and quality system management: Participate in drafting, revising, and reviewing SOPs, procedures, forms, and other quality system documents; perform or support periodic document review, document lifecycle management, and training management to maintain document applicability and alignment with actual operations.

5. 质量事件管理：参与偏差调查和质量事件处理，支持证据收集、影响评估、根本原因分析以及CAPA制定、跟踪和关闭；按职责参与变更和质量风险评估的审核与跟踪。

Quality event management: Participate in deviation investigations and quality event handling, including evidence collection, impact assessment, root cause analysis, and CAPA development, tracking, and closure; support review and follow-up of change controls and quality risk assessments as assigned.

6. 体系运行回顾与持续改进：支持质量体系运行数据汇总、周期性回顾和趋势分析，识别重复性或潜在系统性问题，并推动相关改进措施落实。

Quality system review and continuous improvement: Support compilation of quality system data, periodic review, and trend analysis; identify recurring or potentially systemic issues and drive implementation of appropriate improvement actions.

7. 放行及现场状态支持：按照程序执行或支持标签核查、清场、房间放行确认等QA活动，并为原液生产相关批次放行审核提供质量支持。

Release and area-status support: Perform or support QA activities such as label verification, line clearance, and room release confirmation in accordance with procedures, and provide quality support for batch disposition review related to drug substance manufacturing.

8. 审计与检查支持：支持内部审计、客户审计及监管检查的准备、现场支持、资料提供及相关问题回复，并跟踪责任范围内整改行动的落实。

Audit and inspection support: Support preparation for internal audits, customer audits, and regulatory inspections, including on-site support, document provision, and responses to relevant questions, and follow up on remediation actions within the assigned scope.

9. 完成主管安排的其他相关工作。

Perform other related duties assigned by the supervisor.