บริษัท สยามไบโอไซเอนซ์ จำกัด

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.

Perform the analytical and formulation development for new pharmaceutical or biopharmaceutical product. Testing of active pharmaceutical ingredient, excipient, packaging material, and other material used in pharmaceutical or biopharmaceutical product development. Collect data to prepare the document that used for drug registration. Performing technology transfer of analytical method, and relevant studies to commercial phase. Perform the internal audit and external audit activities according to a defined plan. Perform all necessary qualification, and taking care of equipment and facility used in development process. Taking care of machine, chemical and material inventory that used in DEV Investigates and resolves with team the quality related or development related issues. Work with all departments in implementing and complying with Quality Systems and GMP and ISO14000 requirements

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.

เตรียมสารเคมี สารละลาย อุปกรณ์ที่ใช้ในกระบวนการผลิต เก็บและส่งตัวอย่างต่างๆ จากกระบวนการผลิตตามข้อกำหนด ใช้งานและดูแลรักษาเครื่องมือ เครื่องจักรที่อยู่ในความรับผิดชอบให้พร้อมใช้งานเสมอ ทำความสะอาดและตรวจสอบความเรียบร้อยของพื้นที่ปฏิบัติงานทั้งก่อนและหลังใช้งาน

Manage utility facility operation. Manage maintenance work and develop preventive maintenance program of utility/facility equipement. Prepare spare part for utility/facility to be prompt for maintenance work. Analyze and improve utility/facility system or equipment to increase reliability and dfficiency.