รายละเอียดงาน1.Develop and implement quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements.
2.Establish and maintain a comprehensive quality management system to ensure compliance with all applicable regulations and guidelines.
3.Conduct thorough investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions to address underlying issues.
4.Collaborate closely with cross-functional teams to implement preventive measures and improve processes to minimize the occurrence of deviations and non-conformities.
5.Oversee validation activities for manufacturing processes, equipment, facilities, and computer systems, ensuring compliance with regulatory requirements and industry best practices.
6.Ensure the company is capable of undergoing audits by both customers and regulatory authorities, both domestically and internationally.
7.Manage document control processes, including the development, review, approval, distribution, and maintenance of quality-related documents and records.
8.Provide comprehensive training and ongoing guidance to personnel involved in manufacturing processes, ensuring their full awareness and understanding of quality assurance principles and practices.
9.Collaborate with cross-functional teams to resolve quality-related issues and implement preventive measures to mitigate risks.
10.Monitor key performance indicators to track and measure quality performance, implementing strategies to enhance product quality and safety.
11.Serve as a subject matter expert on quality assurance matters, providing guidance and support to internal stakeholders as needed.