品保部文件培訓專員

Your Role: Document Management •Develop, implement, and maintain the controlled document management system (policies, SOPs, batch records, forms, templates, etc.) in compliance with GMP, FDA, EMA, and other regulatory standards. •Coordinate document lifecycle activities: drafting, review, approval, issuance, revision, and archival. •Ensure controlled documents are accurate, current, and available to relevant personnel. •Maintain document version control and change history in accordance with data integrity principles. •Support regulatory inspections and internal/external audits by providing controlled document access and ensuring traceability. Training Management •Administer and maintain the GMP training management system (electronic or paper-based). •Develop and implement training curricula based on job roles, regulatory requirements, and organizational needs. •Schedule, track, and document completion of GMP and role-specific training for all employees. •Monitor training effectiveness through assessments, metrics, and compliance reporting. •Provide training compliance reports to management and escalate overdue or non-compliant training records. •Support onboarding training for new employees, contractors, and temporary staff.