Qualification & Validation Specialist (Pharmaceutical Manufacturing)

Location: City of Singapore, Singapore Tuas manufacturing site

Company

hirify.global develops and delivers medicines, with this role supporting pharmaceutical manufacturing quality and compliance.

What you will do

• Provide quality oversight for qualification and validation activities across facilities, utilities, equipment, computerized systems, manufacturing processes, decontamination methods, transportation, and analytical instruments.
• Prepare and review validation protocols, reports, risk assessments, traceability matrices, and Validation Master Plans.
• Manage deviations, non-conformances, corrective actions, CAPA activities, and validation-related change controls.
• Assess compliance with FDA, EMA, and other applicable regulatory requirements and quality standards.
• Support internal and external audits and health authority inspections with documentation and technical expertise.
• Collaborate with engineering, manufacturing, quality control, and quality assurance teams while driving continuous improvement and technology transfer activities.

Requirements

• Bachelor’s degree or higher in science, engineering, pharmacy, or a related discipline.
• 5–7 years of qualification and validation experience in pharmaceutical, biotechnology, or another regulated industry.
• Hands-on validation experience with facilities, utilities and equipment, computerized systems, manufacturing processes, and cleaning, sterilization, or disinfection methods.
• Knowledge of validation lifecycle requirements and industry standards including FDA, EMA, ICH, ISO, ASTM, ISPE, and PDA.
• Experience with risk-based and science-based validation, including FMEA, HACCP, and FTA.
• Strong written and verbal communication, cross-functional collaboration, independent execution, and time-management skills.

Nice to have

• Experience in biologics or sterile and aseptic manufacturing.
• Exposure to HSA, FDA, or EMA health authority inspections.
• Knowledge of ALCOA+ data integrity principles.
• Familiarity with electronic validation and document management tools such as Kneat or Veeva.
• Additional certification in quality management, validation, or GMP.

Culture & Benefits

• Work in a regulated manufacturing environment focused on medicine quality, safety, and efficacy.
• Collaborate across quality, engineering, manufacturing, and quality control functions.
• Contribute to continuous improvement and quality excellence initiatives.
• Equal-opportunity workplace supporting people from diverse backgrounds.