| Job Description | Summary:
Provide support to the Compliance department and ensure compliance with cGMP and company policies, procedures and specifications.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
· Conduct and coordinate internal audit and audit result reporting.
· Conduct and coordinate external audit: Qualification for suppliers, GMP service provider, contract lab, etc.
· Prepare audit result report
· Follow up on audit response commitment
· Responsible for the maintenance and update of qualification for suppliers, GMP service providers, contract labs, etc.
· Assist during regulatory, corporate and customer inspections.
· Provide assistance with the Complaint handling system
· Provide assistance in conducting GMP training (globally).
Job Requirements :
Required Knowledge and Skills:
· Excellent communication and writing skills.
· Multi-tasked, ability to work independently or with minimum supervision, efficient
and effective
· Computer literate in MS Office suite (Word, Excel, Power Points, etc.)
· Working knowledge of the 21 CFR Part 210 and 211, GDP and GMP.
Education and/or Experience:
Bachelor’s Degree preferably in Chemistry with 8+ years of experience in pharmaceutical or relevant industry regulated by FDA.
***Must be able to travel. |
| | Company | | Anchen Pharmaceuticals | Job Code | | State or Province | | California | | |
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