Quality Assurance Specialist

Responsibilities

• Build and maintain a pharmaceutical quality system that meets Santen quality manuals, cGMP, and relevant domestic/international regulatory requirements.
• Review manufacturing records, prepare Certificates of Analysis (CoA), and perform batch release decisions.
• Supervise and manage GMP compliance and practices through regular site patrols.
• Manage the lifecycle of GMP documentation (Product Standard Files, SOPs, etc.) based on ALCOA+ principles.
• Lead or support investigations into quality events, including deviations, complaints, changes, and CAPA, including impact assessments and effectiveness evaluations.
• Manage non-conforming products and oversee raw material suppliers and external contractors.
• Develop and improve GMP training programs and execute annual training schedules.
• Create and execute self-inspection plans and support internal/external GMP audits.
• Monitor quality KPIs and drive continuous improvement initiatives within the team.

Requirements

• 3+ years of experience in Quality Assurance (QA) or Quality Control (QC) within the pharmaceutical industry.
• Strong knowledge of GMP, ICH guidelines, FDA regulations, and other relevant regulatory standards.
• Proficiency in English (intermediate level or higher preferred).
• Proven leadership, coaching, and mentoring skills.
• Strong problem-solving abilities and attention to detail.
• High ethical standards and a collaborative teamwork spirit.

About the Company

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with a footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.