Tập Đoàn Dược Phẩm Starmed

Mô tả Công việc

Brief summary of job profile:

• QA Assistant Manager is responsible for supporting QA Manager to implement Quality Management systems and programs that meets the requirements of regulatory bodies, customer expectations, and company policies and standards. This role will also be responsible for conducting audits to ensure that Food Safety & Quality (FSQ) requirements for raw materials, packaging, products, and FSQ systems are fully met.

Key Accountabilities:

Quality Standard Measurement

• Follow Company’s regulations, including not limited to, Food Safety & Quality (FSQ).
• Coordinate with related functions to ensure the implementation, and continuous improvements of applied FSQ systems.
• Assist the QA Manager in writing and reviewing/updating with related functions on relevant FSQ specifications, testing methods, procedures/ work instructions in the area of expertise.
• Plan and conduct external audits to qualify suppliers, assess compliance with FSQ requirements for raw materials, packaging, products, and FSQ systems or verify suppliers’ performance periodically or when having non-conformities regarding materials when necessary.
• Support the preparation of regulatory inspections form the Government.
• Request, verify and follow up with suppliers for Corrective and Preventive Actions (CAPA) when having non-conformities regarding materials. Work with related functions to acquire necessary information serving Root cause analysis and formation of effective CAPA.
• Ensure the Food Safety & Quality Regulations (FSQR) impacts for a change or new materials/ packaging/ process/ products are properly assessed & managed by relevant functions.
• Collect, analyze and report FSQ data, including testing results, vendor performance, customer feedback, and internal audits, to identify areas for improvement.

Training and Documentation:

• Assist the QA Manager in providing consultation & training on specific QA expertise to internal and cross-functional groups.
• Provide guidance on FSQ regulations for departments within the company where needed and suppliers, ensure suppliers’ understanding and compliance to relevant regulations of supplied materials.
• Maintain and update new FSQ regulations of local/ exporting markets.
• Ensure proper document control for FSQR documents required from suppliers and ensure other departments follow document control requirements of applied FSQ systems.
• Maintain accurate and organized documentation to demonstrate compliance with standards and regulatory requirements.