GMP审计员（自由职业）
GMP Auditor (Freelance)
医学在这里不断前进，你也将随之进步。
ADAMAS Consulting帮助全球制药和生物技术公司达到最高质量、合规性和患者安全标准。自2007年以来，我们与GCP、GVP、GMP、GLP和计算机系统合规领域的组织建立了合作关系，并被生命科学领域许多备受尊敬的公司所信赖。
我们认为我们的工作不仅仅是审计。在最好的情况下，它是一种洞察力：帮助客户看到最重要的合规风险，并防止可能危及患者的潜在问题。这需要敏锐而独立的思维以及深厚的专业知识，而这正是我们的员工所带来的。
- 根据预期质量和时间表，规划、准备、执行、报告和后续跟进各种类型的GMP审计
- 基于对所有监管要求和良好生产规范（GMP）的全面理解执行审计
- 代表制药/生物技术行业的客户公司开展GMP质量保证项目
- 具有为多种利益相关方进行和领导内部和外部GMP审计的经验
- 具有进行各种服务提供商审计的经验将是一个优势（例如API制造商、CMOs）
- 具有协调和管理赞助商和研究者现场GMP流程检查的准备活动的经验
- 具有对现行适用监管标准的充分理解和经验
- 精通国家和国际GMP法规和指南
- 熟练管理项目并确保按时交付成果
- 能够以务实的方式识别问题并提出解决方案
- 生命科学学士学位优先
- 可能需要最多40%的差旅，并能够进行远程审计
为什么加入ADAMAS？
当你加入Ergomed集团时，你通过帮助将安全有效的药物治疗带给全球患者而产生影响。你将加入一个充满热情且协作的专家团队，他们在临床研究、药物警戒和质量咨询领域具有专业知识。
我们在许多方面都具有多样性，但我们的价值观将我们团结在一起。我们的价值观是我们的工作方式，而不是墙上的标语。如果它们听起来像你，你会在这里感到自在。
· 质量：我们对自己提出患者应得的标准。
- 正直与信任：我们做正确的事，尤其是在困难的时候。
- 动力与激情：我们关心结果，因为
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Medicine moves forward here. So will you.
ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences.
We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.
- Planning, preparation, conduct, reporting and follow up of various types of GMP audits according to expected quality and timelines
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Manufacturing Practice (GMP)
- Performing GMP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Experience in conducting and leading internal and external GMP audits for a variety of stakeholders
- Experience in conducting a range of service provider audits would be an advantage (e.g., API manufacturers, CMOs)
- Experience in coordinating and managing inspection preparation activities for GMP process inspections both at the sponsor and investigator site.
- Experience and full understanding of current applicable regulatory standards.
- Expert knowledge of national and international GMP legislation and guidelines
- Proficient in managing projects and ensuring deliverables are provided in a timely manner
- Ability to identify issues and offer solutions in a pragmatic way
- BS in Life Science preferred
- Up to 40% travel and ability to conduct remote audits
Why ADAMAS?
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.