概述

• 薪资

  3,800 MYR ~ 4,500 MYR

• 工作行业

  Manufacturing(Pharmaceutical/Medical Equipment)

• 工作内容

  Quality Assurance / Quality Management
  • Draft, review, and revise local SOPs, work instructions, and manuals for QA/QM activities in accordance with global SOPs and local regulations.
  • Maintain quality records in compliance with local/global SOPs, Good Distribution Practice (GDP), and other relevant guidelines.
  • Maintain oversight of the Document Management System (DMS), ensuring proper version control and document archival.
  
  Training & Quality Culture
  • Perform the role of Training Administrator, ensuring the training system remains compliant, up to date, and aligned with regulatory and global QA requirements.
  • Manage trainings via the e learning management system.
  • Conduct GDP refresher trainings and onboarding sessions for internal teams.
  
  Quality System Management
  • Initiate, assess, coordinate, and close change controls.
  • Manage deviations, product complaints, and returned goods, ensuring timely investigation, communication, and closure.
  • Track and manage Corrective & Preventive Actions (CAPA) to ensure timely and effective implementation.
  • Coordinate Product Quality Reviews (PQR) and collaborate with regional/global teams for data consolidation.
  • Lead the annual management review on quality objectives.
  
  Regulatory & Compliance
  • Support local GDP inspections by health authorities and conduct internal GDP self inspections to ensure compliance with regulatory and quality system requirements.
  • Ensure quality compliance for product imports, redressing activities, and release to local markets.
  • Manage mock recall exercises to ensure readiness and compliance.
  
  Vendor / Outsourced Activities Management
  • Manage outsourced activities to ensure vendors meet local and global quality standards.
  • Participate in qualification and periodic requalification of vendors.
  • Track vendor performance metrics and follow up on quality issues or improvement actions.
  • Support preparation and execution of vendor audits and ensure timely closure of audit findings.
  
  Cross Functional & Regional Collaboration
  • Collaborate with cross functional teams (Supply Chain, Commercial, Regulatory, etc.) to ensure quality compliance in distribution and operational activities.
  • Support regional/global quality initiatives and system implementation.