Quality Assurance Manager

Key Responsibilities

• Implement and manage local quality systems and training programs as necessary to support CAPA, complaint handling, inspection reporting and tracking, policy implementation, supplier management, document and change control management, distribution and material control
• Develop and maintain Quality Management System Manual while minimizing cost increases and potential disruptions to business. Ensure the implementation and maintenance of activities related to compliance to policies, processes, procedures and plans that define these elements necessary to meet the Quality objectives, along with Regulatory and business requirements
• Represent the affiliate in projects or issues as required
• Interpret, evaluate and update management on local regulatory regulations, requirements and standards.
• Provide integrated QA support in QA related issues for EPD Supply Chain
• Provide support to local outsourcing activities and product launches through management of the First Lot Quality Review program
• Assure that all distributed products in Singapore conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards.
• Responsible for management of local over-labeling / redressing activities and ensure the activities comply with GMP, Company Corporate and Divisional Quality standards and local regulatory standards.
• Provide instructor-led training for quality activities and systems such as DARIUS, ISOtrain and SolTRAQs.
• Responsibilities for document creation and maintenance in DARIUS
• Perform ISOtrain training coordinator role to create courses, modules, generate monthly reports and carryout reconciliation of overdue trainings.
• Ensures implementation of quality metrics at Affiliate level, including adherence to set targets and goals.