Quality Compliance Manager - Europe Cluster
加入 EVA Pharma,致力于促进为健康和福祉的斗争作为一个基本人权。我们被认可并获得最佳工作场所证书，致力在培养团队成员的支持性和创新环境中。职位总结**质量合规管理员 （兼职）**负责维护和不断完善德国质量管理体系 (QMS),确保遵守德国和欧盟制药法规。负责监督质量流程，检查，审计，培训，供应商资格，CAPA 管理和外部合作伙伴的质量监督，以确保组织保持准备对检验并完全符合 GxP 要求.####关键责任 - 维护和持续改善本地质量管理系统 (QMS). - 管理质量文件，包括 SOP,表单，记录和定期审查。-协调员工培训，资格计划和合规记录。- 主要供应商，客户和服务提供者资格活动。- 规划，进行和跟踪内部审核和质量评估。- 管理偏差，质量事件，CAPA 和流程改进倡议。- 监督与制造商，外部服务提供者以及批发合作伙伴的质量相关界面。- 准备，协调并支持监管机构检查，同时确保持续的检查准备性。#####就业类型 **兼职 ▷ 远程 （总部位于德国）**
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Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary
The **Quality Compliance Manager (Part-Time)** is responsible for maintaining and continuously improving the German Quality Management System (QMS), ensuring compliance with German and EU pharmaceutical regulations. The role oversees quality processes, inspections, audits, training, supplier qualification, CAPA management, and quality oversight of external partners to ensure the organization remains inspection-ready and fully compliant with GxP requirements.
#### Key Responsibilities
- Maintain and continuously improve the local Quality Management System (QMS).
- Manage quality documentation, including SOPs, forms, records, and periodic reviews.
- Coordinate employee training, qualification programs, and compliance records.
- Lead supplier, customer, and service provider qualification activities.
- Plan, conduct, and follow up on internal audits and quality assessments.
- Manage deviations, quality events, CAPAs, and process improvement initiatives.
- Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners.
- Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.
#### Employment Type
**Part-Time | Remote (Germany-based)**