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 |
|
|
|