หน้าที่ความรับผิดชอบ

Key Job Functions:

• Supplier Qualification
• Area Quality/ Product Release

Key Responsibilities:

• 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 related works as assigned.