• Experience in LAB area and LAB investigations is required. • Audits Manufacturing, Packaging and Labeling Materials Investigations Reports for compliance with cGMP’s and SOP’s. • Performs the periodic IR Reviews and manages the Corrective and Preventive Action (CAPA) program for Manufacturing, Packaging and Labeling Materials Investigations. Responsible for managing the QA Hold system and the Special Disposition Inventory (SDI) for products, as well as aiding in the improvement of Quality cGMP systems.

• Evaluates Investigation Reports and all related documentation for corrective/preventive actions (CAPA) included in investigations. Ensures the timely closures of the Investigation Reports. • Performs and reports the Manufacturing, Packaging and Labeling Materials Investigations Reports periodic review. • Evaluates possible product trends and reports them to the QA Management. • Manages the CAPA program, CAPA commitments and ensures the closure of the reported actions by the assigned responsible person by the reported targeted date. Completes audits and files all documents related to the CAPA program procedures. • Manages the QA Hold system by placing and removing from QA Hold the materials and products as designated. • Maintains the QA Hold log with the current status and manages any hold status change. Responsible for the completion, audit and filing of all documents related to the QA Hold system and procedures. • Manages the SDI System as per current QA Hold procedures and reports SDI System status to the QA Management. • Manages the disposition given to the lots in the SDI System • Schedules periodic meetings for discussion and tracking of Investigation Reports, CAPA’s, QA Hold and SDI programs.

Shift based on business needs (1st, 2nd or 3rd Shift)

• Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. • Must possess knowledge of Investigation Reports, QA Hold and CAPA concepts, procedures, and requirements. Strong knowledge of cGMP’s and pharmaceutical regulations.

CAGUAS



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