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.
Evaluating and determining the adequacy of
corrective action plans as provided by auditees
in response to audits conducted.
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 EnvironmentalProtection 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.
Interested parties please send full resume and salary expected to Michael Teng - mteng@Intlcompliance.com
{All personal data to be collected for recruitment purpose only}
