(資深) 品保專員 (Sr.) QA Specialist

1. Facilitate the Lotus disposition process including:
-Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis.
-Managing timelines and resources to ensure the disposition of material in accordance with Lotus' SOPs and within agreed timelines.
2. Support and ensures the successful day-to-day operations for the company.
3. Perform batch disposition activities in accordance with Lotus' SOPs and within agreed timelines.
4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements.
5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner.
6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor function