Key Responsibilities
Preparation, review, revision, and control of SOPs, STPs, specifications, and QC documents.
Handling of Deviations, OOS/OOT, CAPA, and Change Control.
Maintaining QMS records and ensuring compliance with cGMP, GLP, GDP, and Data Integrity (ALCOA+) requirements.
Supporting internal, customer, and regulatory audits.
Coordinating training activities and ensuring document compliance within the QC department.
Performing trend analysis and timely closure of QMS activities.