Descripción del Trabajo
Release Technician works with the final review of the product documentation to ensure that the product was manufactured according to DMR guidelines and according to local requirements and regulations. This role is responsible for the DHR of each product batch containing all the required information in compliance with local requirements, standards and regulations.
Review production records to verify compliance with procedures. • Recommends modifications to existing ones, or suggests new rules, methods and procedures. • Audits, maintains and generates accurate records, records and quality reports. • Ensures that documentation and procedures comply with customer specifications, industry standards, and standard operating procedures. • Works with all quality control and manufacturing personnel to achieve regulatory compliance. • Maintain files for batch history records (DHR). Check the HRRs to see if they are complete and accurate. Fill out the batch history/batch release closing form. • Works and tracks as needed with shipping to complete the necessary information on Certificates of Compliance/Analysis for product shipments. • Adhere to all safety and health rules and regulations associated with this position and as directed by the supervisor. • Comply with and follow all procedures within the company's security policy.
• You can perform other assigned tasks and responsibilities. They may perform other assigned roles and responsibilities.
• Receive and archive the manual records generated at the Site.