Lead document and records control for the QMS, managing SOPs, batch and testing records, periodic reviews, filing/archival, audit retrievals, EDMS maintenance, and cross-functional training to ensure compliance with USP, GMP, and regulatory requirements.

Inspect and assess all incoming materials (APIs, excipients, packaging) for fit-for-use; review CoAs, quarantine/release decisions, document findings, manage supplier quality, improve IQA processes, and support audits and regulatory compliance.