職務說明 / Key Responsibilities
• Implementation and maintaining the Quality Management System and ensure the overall effectiveness of the system involving cross markets level.
• Manage Third Party Logistics (3PL), suppliers and distributors
• Support and conduct audits activities as applicable including external (TFDA / BOH), internal, suppliers and distributor.
• Follow up and coordinate with cross functional team on post auditing activities and drive NC /CAPA activities till closure.
• Track on quality compliance metrics, identify, analyze gap, recommend initiatives for continuous improvement and compliance enforcement.
• Support and coordinate on site management review.
• Support on post market surveillances activities on a timely manner not limited to Field Action, Recall, Medical or Adverse Event reporting.
• Support on document control system and training system.
• Support cross functional product release activities at the regional distribution centers as required including inspection and over labeling/rework.
• Accountable for Quality management of repacking, relabeling, over labeling, kitting, reworking conducted within the DC.
• Support on project assignment/initiatives from the line manager.
• Support/lead activities, projects and initiatives to integrate information from compliance audits and assessments and regulatory trends.
• Identify, escalate regulatory, compliance, and quality issues to management.
• Ensure applicable relevant internal standards and processes across the business without compromising customer expectations.
• Performs other ad hoc related tasks as required.
需求條件 / Key Requirements