e-Lab Superintendent / Batam, Indonesia — Novexx Pte Ltd — Singapore

Manage and facilitate the Quality Management System implementation, standardization and adherence within Laboratory Operation in accordance to cGMPs, legal, ISO, regulatory requirements as well as Quality Manual requirements.Review laboratory testing OOS, SOPs, failure investigation, and OOS record review and testing process status, CAPA, non-conformance management for Batam manufacturing.Develop, implement and maintain the internal audit program for Laboratory. Perform internal audits for laboratories per an established schedule ensuring all quality systems and controls for laboratory.Assist in hosting Regulatory Inspections. Responsible for ensuring all observations are appropriately addressed and compliance review initiated.Responsible for the laboratory adherence associated with laboratories computerized system. Regularly review and audit the laboratory system.Responsible for the review of validation and process changes in of laboratories system to ensure compliance with standards and submissions.Responsible for the GMP and technical training programs for laboratories to ensure they incorporate the required modules to sustain compliance.Responsible for ensuring data integrity is maintained through routine audits of quality systems.Work with the laboratory staff to ensure quality plans are being maintained.

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