(資深)品管專員(Sr.) QC Specialist (微生物Microbiology)

1. Review and enforce adherence to quality standards and agreements. 

2. Manage non-conformance investigations and compliance. 

3. Oversee GMP and regulatory compliance. 

4. GMP Supplier Oversight: 

-Oversight the GMP Vender Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both auditors and vendors. 

-reviewing supplier audit reports, ensuring they meet Lotus QA Standards and are compliant with Lotus SOPs. 

-Submitting observation reports to vendors, communicating response timelines and tracking them to ensure timely responses. 

Review of vendor audit responses and managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy. 

5. Manage quality assurance tasks including document control and investigations.