Job Purpose
To control, maintain, archive, retrieve and protect company and GMP-related documents and records, ensuring document traceability, confidentiality, availability and prevention of use of obsolete documents.
Key Responsibilities
· Receive, register, classify, index and archive controlled documents and records.
· Maintain controlled copies of SOPs, forms, specifications, master documents and related quality records.
· Archive BMR/BPR, QA, QC, validation, qualification, calibration, training and other approved records according to the document retention system.
· Control distribution, retrieval, replacement and withdrawal of controlled documents.
· Ensure obsolete or superseded documents are removed from points of use and appropriately archived or destroyed according to procedure.
· Maintain both physical and electronic document filing systems.
· Provide controlled records promptly for internal audits, regulatory inspections and management review.
· Protect confidential and controlled information and maintain document integrity.
· Support document issuance, revision tracking and document status monitoring.
· Coordinate with QA and other departments to ensure timely submission and filing of required records.