บริษัท อินเตอร์ไทย ฟาร์มาซูติเคิ้ล แมนูแฟคเจอริ่ง จำกัด

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Urgently Required

Nov 20, 2024

Validation Supervisor

สถานที่ปฏิบัติงาน

Chatuchak, Bangkok

เงินเดือน

ไม่ระบุ

อัตรา

สมัครงาน

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Job Descriptions

MAJOR TASKS: 1.Environment monitoring program 2.Validation & qualification master plan 3.Training and Development Responsible in following up and recording all validation activities in the plan to assure that perform and update validation & qualification system are in accordance to specifications and CGMP requirement. DUTIES & RESPONSIBILITIES: A. GMP/ISO/SAFETY 1.Follow up Include individual validation plan of the following but not limited to:- Process (GMP) validation Process (Product) validation Facilities validation Cleaning validation System, Utility and Equipment Qualification Analytical method validation Computerized system validation 2.Follow up with concerned department to perform all validation according to the set up validation master plan. 3.Follow up equipment qualification of new equipment and major change of existing equipment. 4.Establish cleaning validation protocol and conclusion of critical manufacturing equipment. 5.Follow up facility validation of new facility and major change of existing facility. 6.Follow up validation document from concerned department. 7.Keep and control validation document. 8.Prepare and update concerned document: work instruction, Quality procedure, etc. 9.Co-ordinate for validation activities of new manufacturing equipment, system, utility and facility project to guide and conduct validation & qualification plan. 10.Follow up and report the environmental monitoring program is state and effectively carried out (water, air, personal hygiene) as per the plan. B. DOCUMENTATION 11.Prepare validation document, work instructions, validation procedure and related documents. 12.Prepare validation master plan. 13.Review validation protocols, validation report, calibration reports. C. MANAGEMENT 14.Develops and implement validation training program. 15.Ensures that the validation systems cost effective. 16.Enforces company polices on CGMP discipline and safety. Performs other duties that ma

Qualifications