บริษัท สยามไบโอไซเอนซ์ จำกัด

สอบเทียบเครื่องมือวัดด้านเคมี และปริมาตร บำรุงรักษาเครื่องมือให้พร้อมใช้งานอยู่เสมอ ให้ความร่วมมือกับกิจกรรมระบบบริหารงานคุณภาพและกิจกรรมต่างๆตามนโยบายบริษัท ปฏิบัติงานอื่นๆที่ได้รับมอบหมาย

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.

1.ปฏิบัติงานรับ-ส่งผู้บริหาร 2.ดูแลช่วยเหลืองานธุรการอื่นๆ ระหว่างวัน 3.บันทึกการปฏิบัติงานรถรับส่งรายวัน

Maintain effective material and supplier qualification system in accordance with the GMP requirements. Establish, implement, maintain, and improve the material and supplier qualification system in accordance with the GMP requirements. Supplier audit Review and release batch manufacturing records, Batch packing records and QC results of company’s product. Review and evaluate environment monitoring data Prepare data for annual product quality review Execute according to procedure of Complaint, Recall and returned product. Effectively maintain QA procedures in compliance with GMP guideline, Customer and regulatory requirements. Co-ordinate with the responsible team to effectively implement quality management system. Co-ordinate with the system owner to assure that the qualification/validation have been implemented according to the protocols. Search necessary support quality information as assigned. Co-ordinate with the responsible team to implement quality management system to ensure that all QMS activities, e.g. change control, deviation, CAPA, audit, risk assessment, etc., are completed within timeframe and comply with the requirements. Assist and coordinate with relevant departments to perform the qualification and validation activities. Cooperate internal audit that are performed according to define plan.

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