GCLP审计员（自由职业-需具备CAP/CLIA经验）
GCLP Auditor (Freelance - CAP/CLIA experience required)
医学在这里不断前进，你也将随之成长。
ADAMAS Consulting帮助全球的制药和生物技术公司维持最高标准的质量、合规性和患者安全。自2007年以来，我们与涵盖GCP、GCLP、GVP、GMP、GLP和计算机系统合规性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问题。这需要敏锐而独立的思考和深厚的专业知识，而这正是我们的员工所带来的。
在这里，你的知识受到重视并被分享，而不是被孤立。我们建立了一个支持性、协作的环境，鼓励专业成长，并让你能够在整个行业中产生真正的影响力，与该领域的许多知名公司合作。
- 根据预期质量和时间表，规划、准备、执行、报告和后续处理各种类型的GCLP审计，包括CAP/CLIA
- 基于对所有监管要求和良好临床实验室实践（GCLP）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GCLP质量保证项目
- 生命科学学士学位优先
- 具有为多种利益相关者进行和领导内部和外部GCLP审计（包括CAP/CLIA）的经验
- 具有进行各种供应商审计的经验
- 具有进行GCLP系统审计的经验
- 具有协调和管理赞助方和研究者现场GCLP流程检查的检查准备活动的经验
- 具有进行符合监管机构标准的GCLP模拟检查的经验被视为一大优势
- 精通国家和国际GCLP法规和指南
- 可能需要40%的差旅，并能够进行远程审计
为什么选择ADAMAS？
当你加入Ergomed集团时，你将通过帮助将安全有效的药品带给全球患者来产生影响。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长。
我们在许多方面都多元化，但我们的价值观将我们团结在一起。我们的价值观是我们工作的体现，而不是墙上的一句话。如果这些价值观与你相符，你会感到如鱼得水。
查看英文原文
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, GCLP, 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.
Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.
- Planning, preparation, conduct, reporting and follow up of various types of GCLP audits including CAP/CLIA according to expected quality and timelines
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Laboratory Practice (GCLP).
- Performing GCLP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- BSc in Life Science preferred
- Experience in conducting and leading internal and external GCLP audits including CAP/CLIA for a variety of stakeholders
- Experience in conducting a range of service provider audits
- Experience in conducting GCLP systems audits.
- Experience in coordinating and managing inspection preparation activities for GCLP process inspections both at the sponsor and investigator site.
- Experience in conducting GCLP mock inspections to Competent Authority standard considered a significant advantage.
- Expert knowledge of national and international GCLP legislation and guidelines
- 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.