Key Responsibilities

• Manage and maintain the Document Management System (DMS) for GMP and quality-related documents.
• Control issuance, retrieval, numbering, and archival of SOPs, batch records, forms, and specifications.
• Ensure proper version control and timely revision of controlled documents.
• Verify documentation for compliance with GMP, GDP, and data integrity (ALCOA+) principles.
• Coordinate with different departments for document preparation, review, approval, and implementation.
• Maintain document history logs, master lists, and tracking records.
• Ensure timely distribution of approved documents to respective departments.
• Support audits and regulatory inspections by providing required documentation.
• Ensure obsolete documents are properly withdrawn and archived.
• Assist in training employees on document control procedures and system usage.
• Maintain confidentiality and security of controlled documents.
• Support implementation and maintenance of electronic DMS (eDMS), if applicable.