3/25 (Sr.) Associate, Quality Assurance (資深) 品保專員
- 台灣微脂體股份有限公司
- 生化科技研發業
- 台北市南港區
- 3年以上
- 大學
Essential Duties and Responsibilities: We are seeking a highly motivated and detail-oriented individual to join our Quality Assurance team. The ideal candidate has experiences in commercial drug quality activities and document management, with a strong commitment to maintaining the highest standards of quality and compliance in delivering pharmaceutical products. We are flexible to consider more senior roles depending on candidate qualifications. Quality Assurance Oversight: 1.. Conduct regular reviews of processes and documentation to ensure compliance with regulatory requirements and company standards. 2.. Perform batch record reviews and disposition activities in accordance with established procedures. 3.. Participate in internal and external audits, including preparation of audit documentation and response to audit findings. 4.. Collaborate with cross-functional teams to investigate deviations, non-conformances, recall handling, and customer complaints, and implement corrective and preventive actions as necessary. Document Management: 1.. Maintain and update quality documentation, including standard operating procedures (SOPs), batch records, specifications, and other quality-related documents. 2.. Ensure document control procedures are followed for the creation, approval, distribution, and archiving of quality documents. 3.. Support document change control processes, including reviewing and approving document revisions and ensuring timely implementation. Training and Compliance: 1.. Provide training to manufacturing personnel on quality procedures, GMP requirements, and document management processes. 2.. Ensure compliance with regulatory requirements, including FDA, EMA, and other applicable regulations and guidelines. 3.. Stay informed about current industry trends and regulatory developments related to quality assurance and document management. 4.. Identify opportunities for process improvements and efficiency enhancements within the Quality Assurance function. 5.. Participate in cross-functional teams to implement process improvements and drive a culture of continuous improvement throughout the organization.