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
∑ 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:
Bachelorís Degree preferably in Chemistry with 8+ years of experience in pharmaceutical or relevant industry regulated by FDA.
***Must be able to travel.
State or Province