Job Description

主要职责

• 建立并维护与数据、文件管理有关的质量体系，并遵守本地cGMP和公司AH质量手册章节。
• 负责MEDS系统的维护，文件的生效、分发等工作。
• 建立并维护与种子管理有关的质量体系，并遵守本地cGMP和公司AH质量手册章节。
• 负责所负责区域的非验证相关的偏差、CAPA、变更的审核和管理，现场走查及相关文件的审核。
• 确保符合公司AH质量手册的意图，使负责的宁波工厂质量体系保持一致，并在需要时针对本地要求和质量手册核心要求之间的差异调整并记录。

任职要求

教育程度：

化学、药学、生物学、化学工程或相关科学专业的学士学位，学士学位以上更佳。

工作经验：

至少有2年制药行业质量管理经验。

特殊技能：

• 具备良好的人际交往能力，包括领导能力、指导和发展能力、绩效管理能力、激励能力、沟通能力和谈判能力；
• 具有基于现场制造或质量管理职位的经验；
• 对GMP法规、指南、期望及其在日常运作中的应用有较强的知识和理解；
• 较强的分析和解决问题的能力；

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

cGMP Compliance, Complaint Management, Decision Making, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Auditing, Quality Management, Quality Standards, Quality Support

Preferred Skills:

Document Management

Job Posting End Date:

01/31/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.