Lead review and approval of batch records, investigations, deviations, change controls, CAPAs, quality risk assessments, protocols, reports, and GMP documentation.
Lead and facilitate quality system activities, including deviation management, CAPA, change control, document control, and quality risk management, Complaint Management, Product Recall as assigned.
Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards..
Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.