合同机会 - 高级场外交易合规审计师（为前FDA检查员提供绝佳机会）
Contract Opportunity - Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)
我们是SGS——全球领先的检测、检验和认证公司。我们被公认为可持续性、质量和诚信的全球标杆。我们的99,600名员工在2,600个办公室和实验室中开展工作，共同推动一个更美好、更安全、更互联的世界。
我们正在寻找一位经验丰富的分包商——OTC合规审计师，要求具备前FDA检查员/调查员背景。此次短期任务（2026年5月至8月）需要在非处方药生产、cGMP合规性和FDA检查方法方面具备专业知识。
作为分包商，您将支持客户在非处方药制药行业的审计、检查准备活动和合规审查。
主要职责
· 对非处方药生产、包装、标签和实验室操作进行cGMP合规性审计。
· 应用FDA检查方法识别合规差距、风险和缺陷。
· 编写详细且专业的审计报告，列出观察结果和建议的纠正措施。
· 支持客户进行模拟FDA检查、检查准备活动和合规整改。
· 审查质量体系、标准操作规程、批记录、数据完整性控制和实验室实践。
· 在国际客户合作中专业地代表公司。
· 作为外部承包商独立管理日程安排、差旅和交付成果
- 具有前FDA检查员/调查员经验（必需）。
- 在非处方药或制药生产领域有3–5年的审计经验。
- 熟悉cGMP要求、非处方药专论期望和FDA执法实践。
- 具备独立开展高水平审计并清晰表达发现的能力。
- 优秀的沟通和专业技术写作能力。
差旅
· 必须愿意并在合同期间内能够进行国际差旅，包括北美以外地区。
有兴趣吗？
如果您是具有OTC审计经验的前FDA检查员，并愿意接受全球合同任务，我们希望与您联系。
SGS是一家平权雇主，因此我们在所有职位分类中招聘、雇佣、培训和晋升人员时，不考虑种族、肤色、宗教、性别、国籍、残疾、年龄、婚姻状况、性取向、性别认同或表达以及原住民身份，或其他受法律保护的特征。
要成功完成此工作，个人必须能够执行每项职责。
查看英文原文
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
We are seeking a highly experienced Subcontractor – Senior OTC Compliance Auditor with a background as a former FDA Investigator/Inspector. This short-term assignment (May-August 2026) requires expertise in OTC drug manufacturing, cGMP compliance, and FDA inspection methodology.
As a subcontractor, you will support audits, inspection readiness activities, and compliance reviews for clients in the OTC pharmaceutical industry.
Key Responsibilities
· Conduct cGMP compliance audits of OTC drug manufacturing, packaging, labeling, and laboratory operations.
· Apply FDA inspection methodology to identify compliance gaps, risks, and deficiencies.
· Prepare detailed, professional audit reports outlining observations and recommended corrective actions.
· Support clients with mock FDA inspections, inspection readiness activities, and compliance remediation.
· Review quality systems, SOPs, batch records, data integrity controls, and laboratory practices.
· Represent the organization professionally during international client engagements.
· Manage scheduling, travel, and deliverables independently as an external contractor
- Former FDA Investigator/Inspector (required).
- 3–5 years of auditing experience within OTC or pharmaceutical manufacturing.
- Strong understanding of cGMP requirements, OTC monograph expectations, and FDA enforcement practices.
- Proven ability to conduct independent, high‑level audits and articulate findings clearly.
- Excellent communication and technical writing skills.
- Travel
- Must be willing and able to travel internationally, outside of North America, for the duration of the contract.
- Interested?
- If you’re a former FDA inspector with OTC auditing experience and open to a global contract assignment, we’d like to connect.
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression and Indigenous status, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada