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.