Manufacturing Remediation Specialist
We are seeking experienced professionals to support a site-wide remediation program following an FDA 483.
* This role will focus on manufacturing process validation, quality system updates, and documentation remediation.
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The project involves tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes. Consultants must be able to take a problem statement through to a compliant solution by collaborating cross-functionally across Quality, Manufacturing, and Regulatory teams.