Senior Compliance Specialist

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:
Bachelorís 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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