Quality Operations Expert II

Location: City of Singapore; onsite role

Company

hirify.global develops pharmaceutical products and focuses on improving medications, outcomes, and science.

What you will do

• Perform final drug substance disposition and batch release activities for secondary customers.
• Review batch quality information, resolve release-impacting issues, and participate in Quality Alert and Product Alert meetings.
• Review site deviations, lead or support root cause investigations, and coordinate complaint investigations.
• Assess and approve change controls and perform Product Quality Reviews in line with site and regulatory requirements.
• Identify continuous improvement opportunities through performance metrics, trend analysis, and quality system enhancements.
• Support internal and external audits, regulatory inspections, inspection readiness, and closure of observations.

Requirements

• At least 5 years of Quality Assurance experience in the pharmaceutical industry.
• Strong experience with deviation management and batch release or disposition processes.
• Practical knowledge of Good Manufacturing Practices (GMP) and Quality Assurance principles.
• Experience with quality investigations, change controls, and pharmaceutical quality systems.
• Strong analytical, problem-solving, root cause analysis, organisational, and project management skills.
• Ability to communicate effectively with cross-functional stakeholders and manage multiple priorities in a dynamic environment.

Culture & Benefits

• Work with Manufacturing, Quality, Regulatory, and other site stakeholders.
• Participate in continuous improvement initiatives focused on quality systems and operational effectiveness.
• Equal opportunity workplace supporting people from diverse backgrounds.