品保工程師QA Associate_竹南科學園區

Job description: 1. Ensure change control system is robust and routed in a timely manner. Plan, execute and follow up on internal audit program to assure conformance with 2. Current Good Manufacturing Practices (cGMPs). 3. Coordinate, accompany and follow up Regulatory Authorities GMP inspection, PAI for new product and Third Party Audits by Customers. 4. Perform supplier qualification and maintenance 5. Manage the regulatory updates, implementation and compliance related procedures. 6. Participate, facilitate and review investigations of deviation, laboratory investigations and product complaint. Propose, review and implement corrective and preventive actions to address the identified root cause(s). 7. Collect, compile, review annual product review document. Maintain and provide statistics support of QCAL. 8. Support cleaning validation tasks. 9. Support and execute QIP fo for site innovation, improvement and enhancement of regulatory requirement 10.Other tasks as assigned by the company. Location: The place of work is in Zhunan Town, Miaoli County. The company is Bora Pharmaceutical Zhunan Site(益邦製藥)