职位描述：
Position Title: Auditor
Division: CSCC Shanghai
Location: Shanghai, China
Reports to: Regional Manager
Status: Exempt
Position Summary:
The auditor will conduct audits in order to evaluate compliance to USA Federal Regulations pertaining to the laws regarding foods, drugs, cosmetics and other assorted consumer end use products. Auditor will also conduct audits with respect to cGMP (Current Good Manufacturing Practices-21CFR Parts 210,211) compliance.
The auditor will also be required to assist in Social Compliance audits as needed by their division.
Essential Job Duties and Responsibilities:
1.Perform audits as required including, but not limited to assisting in the development of audit plans; assisting in pre-audit preparation, using established checklists to ensure audit consistency; maintaining records from audits performed; coordinate activities with other audit team members and write audit reports.
2.Evaluating and determining the adequacy of corrective action plans as provided by auditees in response to audits conducted.
3.Auditor should maintain proficiency with current and new regulatory guidelines
Job Requirements:
Education & Experience:
University Degree in Science or related discipline
Experience in GMP audits of one or more of the following: Pharmaceuticals, Dietary Supplements, Medical Devices, Food, or Cosmetics.”
Experience in the manufacturing sector preferred
Knowledge of cGMP Regulations
Knowledge of the US Federal Food Drug & cosmetics Act (FDCA)
Knowledge of the US Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) not required but a plus
Knowledge of the US Toxic Substance Control Act (TSCA) not required but a plus
Familiarity with the US Food & Drug Administration (FDA) & the Environmental Protection Agency (EPA) not required but a plus.
Excellent presentation, written, oral and interpersonal skills with the ability to
effectively communicate with all employees and clients.
Demonstrate problem solving, trouble shooting and negotiating skills.
Excellent knowledge of written and spoken English
Other:
Able to travel an average of 60-80% of the time
Excellent client service and interpersonal skills
Must be flexible and be able to multi task
Must be able to liaise between the company and clients with regards to the regulatory process for food, drugs and dietary supplements.
Must be adaptable, work independently and be able to interact with all employees including senior management, external vendors and clients.
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