Job Description

Key Responsibilities

Ensure strict adherence to cGMP standards, GDP requirements, and all factory safety rules. Issue BMRs/BPRs/ECRs to the Production department as per established procedures. Handle issuance and reconciliation of product labels, hard books, controlled formats, ropes, and tech-lock seals. Assist in the review of vendor qualification documents, BMRs, and ECRs. Maintain proper filing and organization of BMRs, ECRs, Approved Vendor Lists, and other QA records. Manage issuance and retrieval of controlled documents to/from various departments through ENSUR or applicable document control systems. Carry out routine shop-floor visits to ensure compliance with quality procedures and regulatory expectations. Perform line clearance and area clearance activities prior to manufacturing operations. Verify document drop box contents and coordinate secure destruction of documents as per procedure. Support review and approval of executed batch records and cleaning records of SRU operations. Ensure timely archival of QA documents as per SOP requirements. Assist in collecting and compiling data required for preparation of Annual Product Quality Review (APQR). * Support the initiation, documentation, and tracking of change controls and deviations.