งาน 1 ตำแหน่ง: งาน หางาน งานเภสัชกร

รายละเอียด

-Manage overall pharmaceutical manufacturing operations in compliance with GMP and FDA requirements.-Establish and implement production policies, objectives, procedures, and risk management plans.-Ensure production and storage activities are conducted according to approved procedures and quality standards.-Manage and maintain production records, batch records, SOPs, and related documentation.-Ensure proper implementation of GMP requirements and Good Documentation Practices.-Manage and follow up validation activities in coordination with QA, QC, and external contractors.-Establish and maintain GMP training programs and ensure appropriate training for production staff.-Coordinate and support annual self-inspections and FDA inspections, including follow-up on findings and corrective actions.-Monitor production performance, productivity, and target achievement, and drive cost reduction and process improvement initiatives.-Support the introduction and transfer of new products and manufacturing processes between Japan headquarters and the local manufacturing site.-Lead and develop the Production Department team and ensure effective communication across relevant functions.-Promote GMP, quality, safety, 5S, and continuous improvement throughout production operations.-Perform other duties and projects as assigned by the Factory Director.