Senior QA Specialist

About the role

The Senior QA Specialist provides independent commercial quality support for the affiliate, covering quality system requirements for pharmaceutical products, medical devices, combination products, biologics and cosmetics. The role ensures that quality activities from receipt of final product through distribution comply with corporate, governmental and local regulations. It covers Singapore and the Philippines, with ad hoc support for Malaysia, Indonesia and Brunei.

Key responsibilities

• Integrate local quality regulations for drugs, biologics, devices and cosmetics into the affiliate quality system.
• Design quality systems, procedures and processes with cross-functional teams and maintain quality management activities for GDPMD/S, with ad hoc support for GDPMD Malaysia.
• Manage quality principles, local procedures, work instructions, records and quality system documents.
• Investigate quality events such as deviations, nonconformities and complaints, and oversee redressing activities like overlabeling.
• Manage internal and external quality inspections and audits, including reporting, responses and action plan tracking.
• Support supplier qualification, including audits, quality agreements and performance monitoring, and quality management of medical devices such as vaporizers.
• Coordinate change control, controlled temperature shipments, recalls, withdrawals and corrections, and the affiliate's Management Review.
• Run a quality self-inspection program, train staff and communicate quality and compliance matters internally and externally.
• Analyze quality indicators and trends, track metrics and KPIs, and represent the affiliate in regional, global and cross-functional teams.

Required profile

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or another technical/scientific field preferred.
• 3+ years' experience in quality assurance, quality oversight or a relevant field.
• Experience working both in teams and independently, with strong communication skills and proficiency in English.

Required skills

• Knowledge of QA systems and GxP compliance, including regulations for devices, biologics and pharmaceutical products (preferred).
• Technical knowledge of quality, regulatory, process sciences and manufacturing operations.
• Enterprise systems such as SolTraqs, Attaché and Attaché Pro.