职位描述：
Essential Job Duties and Responsiblities:
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:
1.University Degree in Science or related discipline
2.Experience in GMP audits of one or more of the following: Pharmaceuticals, Dietary Supplements, Medical Devices, Food, or Cosmetics.
3.Experience in the manufacturing sector preferred.
4.Knowledge of GMP regulations
5.Knowledge of the US Federal Food Drug & Cosmetics Act (FDCA)
6.knoledge of the US Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)not required but a plus
7.Knowledge of the US Toxic Substance Control Act (TSCA)not required but a plus
8.Familiarity with the US Food & Drug Administration (FDA) & the Environment Protection Agency(EPA) not required but a plus.
9.Excellent presentation, written, oral and interpersonal skills with the ability to effectively communicate with all employees and clients.
10.Demonstrate problem solving, trouble shooting and negotiating skills.
11.Excellent knowlegde of written and spoken English.
Other:
1.Able to travel an average of 60-80% of the time
2.Excellent client service and interpersonal skills
3.Must be flexible and be able to multi task
4.Must be able to liaise between the company and clients with regards to the regulatory process for food, drugs and dietary supplements.
5.Must be adaptable, work independently and be able to interact with all employees including senior management, external vendors and clients.
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