Engineering QA 工程验证QA

1. 01

   确保验证/确认管理体系及数据完整性体系符合FDA、EMA和NMPA等主要监管机构的要求并持续改进。 Ensure the validation/qualification system and data integrity program meet the

of major regulatory authorities (e.g., FDA, EMA and NMPA) and are continuously improved.

2. 02

   确保工程和验证部门相关GMP活动符合监管和内部要求。 Ensure GMP activities compliance with regulatory internal requirements for the Engineering and Validation functions.

3. 03

   审核并批准SOP、验证/再验证文件及生命周期管理文件。 Review and approve SOPs, validation/revalidation documents, and lifecycle management documentation.

4. 04

   确保厂房设施、工艺设备、水系统、HVAC、气体系统和计算机化系统的全生命周期验证（FAT/SAT/DQ/IQ/OQ/PQ）和维护管理的合规性。 Ensure compliance of lifecycle validation (FAT/SAT/DQ/IQ/OQ/PQ) and maintenance management for facilities, process equipment, water systems, HVAC, utility gas systems and computerized system.

5. 05

   管理区域的偏差、变更及CAPA等质量事件的全过程，并进行有效性评估。 Manage quality events end-to-end within the assigned area (including deviations, change controls, and CAPAs) and conduct effectiveness checks.

6. 06

   独立制定验证策略并解决复杂问题。 Independently develop validation strategies and resolve complex issues.

7. 07

   独立撰写并审核验证相关管理流程或验证相关文件。 Independently draft and review validation-related management procedures and validation documentation.

8. 08

   推动跨部门沟通与协作，支持团队目标达成。 Drive cross-functional communication and collaboration to support achievement of team objectives. 二、任职资格 (Qualifications)

9. 01

   制药工程或相关专业，本科及以上学历。 Bachelor’s degree or above in Pharmaceutical Engineering or a related field.

10. 02

    7年以上制药行业经验，有商业化无菌生产企业QA背景。 Minimum 7 years of experience in pharmaceutical industry with commercial manufacturing QA background in aseptic company.

11. 03

    熟悉FDA、EMA、NMPA、ICH、WHO、ISPE等法规及指南。 Familiar with FDA, EMA, NMPA, ICH, WHO, ISPE regulations and guidelines.

12. 04

    熟悉生物制品(原液和制剂）生产工艺并精通厂房设施设备及相关系统验证。丰富的搭建验证体系的经验。从事和监管过厂房设施设备的验证，包括初始验证，再验证，清洁验证，温控厂房和设备的温度分布验证，产品运输验证，灭菌柜/清洗机/无菌生产设备消毒和灭菌验证等。 Familiar with biologics manufacturing process（Drug substance and Drug product) and experienced in facility, equipment, and system validation, with proven experience in establishing validation programs. Experienced in performing and overseeing validation of facilities and equipment, including initial qualification, requalification, cleaning validation, temperature mapping for temperature-controlled facilities and equipment, product transportation validation, and disinfection/sterilization validation for autoclaves, washers, and aseptic manufacturing equipment, etc.

13. 05

    精通偏差、变更、CAPA等GMP PQS流程。 Solid understanding of deviation, change control, and CAPA under GMP PQS

14. 06

    具备验证策略制定和问题解决能力。识别设备/系统等生命周期相关文件的缺陷，并推动改善落地。 Capable of developing validation strategies and solving problems; able to identify gaps in lifecycle documents for equipment/systems and drive corrective improvements.

15. 07

    较强的跨部门沟通能力及团队合作精神。 Strong cross-functional communication and teamwork skills.

16. 08

    熟练的英文读写和沟通能力。 Proficient in English reading, writing, and communication.