『桃園蘆竹廠』品保專員(QA Associate )

●Ensure change control system is robust and routed in a timely manner.
●Maintains an effective document control system.
●Develop, coordinate, monitor and track the personnel training programs.
●Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system.
●Plan, execute and follow up on internal audit program.
● Coordinate, accompany and follow up Regulatory Authorities GMP inspection, PAI for new product and Third Party Audits by Customers.
● Perform supplier qualification and maintenance
●Manage the regulatory updates, implementation and compliance related procedures.
● Ensure Bora GDP procedures are established, followed and executed appropriately in compliance with Current Good Distribution Practices (cGDPs)
● Collect, monitor, and report the quality metrics for the oversight of quality system
Collect, compile, review annual product review document. Collect documents for customer annual report request(s).
●Lead, coordinate, support and execute QIP for site innovation, improvement and enhancement of regulatory requirements.
● Create and revise related SOPs and documents.
● Other tasks as assigned by the company.
● Handle and/or coordinate quality risk management of the site for risks evaluations, controls and mitigations.
● Support QA inspector daily activities as required