Siambioscience

Planning for the product formulation, manufacturing process and analytical method development for new pharmaceutical Oral solid dosage form according relevant regulatory guideline/ requirements. Evaluates and selects materials i.e. active pharmaceutical ingredient, excipient, other procession aid, and packaging material that is suitable for intended used in product and comply to regulatory requirements. Establishes the development study i.e. protocol and report of new product. Prepares and reviews all relevant documents used in Dossier for drug registration. Performing technology transfer of manufacturing process, formulation, analytical method, and relevant studies to commercial phase. Prepares and reviews the evaluation of the possibility of new product development. Prepares and reviews all necessary documents to fulfill the requirements of the GMP, regulatory requirements and quality system. Build up the job morale and motivation for responsible personnel. Cooperate among quality team and production team and other departments to work for pharmaceutical product development. Cooperate to ensure that internal audits and external audits are performed according to a defined plan. Investigates and resolves with team the quality related or development related issues. To ensure that all necessary qualification, maintenance, calibration, and validation of equipment, facility, and utility used in development process is carried out and the associated records evaluated. Work with all departments in implementing and complying with Quality Systems and GMP ISO13485, and ISO14000 requirements.

ดูแล ตรวจสอบและบันทึกสภาพเครื่องจักร Utility/Facility บำรุงรักษาเครื่องจักรและอุปกรณ์ (PM & BM) และรายงานต่อผู้บังคับบัญชา ปฏิบัติงาน Monitoring ระบบ DCS & BAS ที่ควบคุมเครื่อง , ระบบ Utility } Facility

To control overall process of sterile products manufacturing: washing,formulation, filling and capping process. To control and improve overall efficiency, productivity of all manufacturing operations. To control that the production produces according to Production schedule, work instructions To develop facilities, process and techniques for processing sterile products. Review quality document. To prepare production department’s procedures and documents e.g. Batch production record, working instruction, protocol etc. to ensure compliance with GMP/ISO9001.

จัดเตรียมสารเคมี และอุปกรณ์ที่ใช้ในกระบวนการผลิต จัดเก็บ และส่งตัวอย่างต่างๆ จากกระบวนการผลิตตามข้อกำหนด ดูแลความสะอาดของอุปกรณ์ เครื่องมือเครื่องจักร ให้พร้อมใช้งานเสมอ ดูแลทำความสะอาดและตรวจสอบความเรียบร้อยของพื้นที่ปฏิบัติงานทั้งก่อนและหลังปฏิบัติงาน บันทึกเอกสารคุณภาพ และรายงานความผิดปกติที่อาจส่งผลกับคุณภาพผลิตภัณฑ์แก่ผู้บังคับบัญชา

Implement quality assurance activities in accordance with exiting policies and procedures. Review manufacturing records and related documents. Prepare, review and summarize documents of quality management system and follow-up thiers status to ensure that all activities comply with company policy and regulatory requirements Get involve in risk assessment regarding manufacturing process. Perform product quality review. Execute according to procedures of complaint, recall and returned products i.e. coordinate, co-investigate Review and evaluate environment monitoring report Review qualification and validation protocol and report Tracks, reports qualification and validation activities. Cooperates that internal audit and external audit are performed according to a defined plan. Coordinate activities as per assignments by abide to work scheduling and priorities Maintain quality system according to PICs GMDP, ISO14001, ISO13485 and other applicable regulatory agencies/ standard