About the role

AI summarised

Quality Assurance Manager responsible for implementing and maintaining pharmaceutical quality systems, managing CAPA, complaints, audits, supplier qualification, and regulatory compliance across Singapore operations.

HealthcareOnsite

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
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
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
Maintain Management Review process for Affiliate and elevate any significant events or identified risks to management

Requirements

Bachelor of Science degree or equivalent
Minimum 4-5 years of quality assurance experience in pharmaceutical industry
PV experience is preferred
Ability to take the lead in driving projects and initiatives
Executive presence to participate in Leadership meetings and discussions
Fluent in English ability to communicate both in written and orally, to all levels of management and across different cultural backgrounds
Well-developed interpersonal, negotiation and stakeholder management skills