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Associate Director of Compliance

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Job Snapshot
Location:
DFW, TX 76134
Base Pay:
$90,000 - $105,000 /Year
Other Pay:
bonus eligible
Employee Type:
Full-Time
Industry:
Pharmaceutical
Packaging
Medical Equipment
Manages Others:
Not Specified
Job Type:
Pharmaceutical
QA - Quality Control
Education:
4 Year Degree
Experience:
At least 5 year(s)
Division:
ATL
Post Date:
12/4/2009
Contact Information
Contact:
Bill Irwin
Phone:
770-887-7111
Ref ID:
TRBIADC
Description Our Drug Company Client in the SW US Seeks an Associate Director of Compliance.

This position is responsible for  quality improvement  related to the compliance aspects of the Plant business and in accordance with the FDA Code of Federal Regulations  

Responsibility includes:  notification of new or changing regulations (FDA and worldwide) and GMP trends relevant to our facility and analysis of this information on a plant wide basis, development and maintaining the internal audit program and auditors, tracking and facilitation of remedial action for external and internal audits, supplier audit program management,  day to day maintenance of the CAPA system, facilitation of corrective actions for deviations, and quality metrics tracking.  In addition, this position will help to support and lead root cause analysis for complaints as well as other aspects to determine and implement effective corrective and preventative action.

 

 

 

Requirements 5+  years experience in Operations and/or Quality Assurance.  Knowledge of drug regulations, quality systems, and auditing. 

Essential Skills & Abilities:

System knowledge (FDA/GMP, ISO 13485/13488).  auditor skills. organization.  Ability to thrive in a team environment. 

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