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Date Added: 15/03/2004 19:00:38

Quality Assurance
Quality Assurance - Compliance Specialist-Quality Operations

-Develop and execute an annual plan to perform internal audits of Plant Operations and external audits of contractors and suppliers. Assures compliance with regulatory and corporate directives in the following areas:
Self-Inspection, Training, Calibration Program, Annual Product Reviews, Validation, Change Management, OOS, SOPs, etc… Prepare and issue written
audit reports on observations.
Prepare and issue routine progress and assessment reports on site cGMP
compliance. Performs verifications of corrective action progress and completed
commitments. Provides input to operations management concerning regulatory
requirements.
-Escort investigators from FDA, EMEA, etc. or other third party agencies during plant inspections and issue reports to Senior Management.
-Provide assistance to site in regards to Quality System Program (Continuous Improvement) initiative.
. Northeast USA

Type: Permanent  
Location: Northeast USA  
Availability: ASAP  
Salary/Rate: will depend on location  
Reference: 841