Quality Assurance Operational Support

Location: Tuas, Singapore; on-site work with 12-hour rotating day/night shifts, including weekends, required during engineering, PPQ, and routine production operations.

Company

hirify.global is developing the EVolutive Facility, a modular vaccine manufacturing site that combines GMP operations with digital and automation technologies.

What you will do

• Partner with GMP operations, manufacturing, facilities, Quality Control, and technical teams to provide QA advice and on-the-floor oversight.
• Review and approve engineering, operational, process, SOP, work-instruction, and batch-record documentation.
• Support installation and operational qualification activities, engineering runs, PPQ runs, and site operational readiness.
• Support digital manufacturing infrastructure, including DeltaV recipes, MES workflows, process equipment systems, and ERP setup.
• Manage and resolve deviations, change controls, CAPAs, raw-material and drug-substance-intermediate release activities, and root-cause investigations.
• Support inspections, QA training, continuous improvement, and the Quality Manufacturing 4.0 plan.

Requirements

• Bachelor’s or Master’s degree in science, engineering, or another related technical field.
• Minimum 4 years of relevant experience in manufacturing, validation, engineering, or quality within the pharmaceutical or biotechnology industry.
• Expertise in pharmaceutical regulations, global Quality policies, data integrity, GMP operations, Quality Management Systems, and Quality Risk Management.
• Knowledge of manufacturing processes, electronic batch records, MES review processes, batch release and disposition, preferably using SAP.
• Ability to work independently, make effective decisions under pressure, communicate across organizational levels, and build a strong Quality culture.
• Ability to work office hours during preparation phases and 12-hour rotating on-site shifts, including nights and weekends, during engineering, PPQ, and routine production operations.

Nice to have

• Experience in vaccines, biologics, or facility start-ups.
• Familiarity with Manufacturing 4.0, Agile methodology, Digital 4.0 concepts, and risk-based decision frameworks.

Culture & Benefits

• Work within a cross-functional GMP manufacturing environment focused on quality, safety, reliability, and operational efficiency.
• Contribute to a digital acceleration program and the development of a new modular manufacturing concept.
• Participate in building an embedded Quality culture across operations.
• Equal-opportunity workplace with a focus on inclusion and diversity.