Specialist I, Quality Control Systems

Location: City of Singapore, Singapore

Salary: Not specified

Company

hirify.global develops healthcare solutions, vaccines, and biological platforms, including mRNA manufacturing, and is establishing new digitalized Modulus Facilities.

What you will do

• Support routine operations of the new EVF-QC laboratory in Singapore.
• Maintain QC GxP systems and support computerized system validation in line with hirify.global standards and regulatory guidance.
• Manage LIMS, including master data maintenance, change implementation, setup, and data structure activities.
• Provide user administration, access reviews, troubleshooting, problem management, and configuration management for laboratory systems.
• Author and own QC Systems procedures, perform periodic audit trail reviews, and support data integrity risk assessments.
• Partner with Digital and global teams on data backup, restoration, archival, and global GxP system implementations or upgrades.

Requirements

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, related Life Sciences, or IT/Technology.
• Minimum 4–5 years of experience in QC Systems.
• Good understanding of 21 CFR Part 11 and data integrity requirements.
• Competence in GxP applications and systems.
• Experience leading projects to roll out GxP systems or software such as Empower and Omnis.
• Familiarity with LIMS setup and data structures.
• Experience in troubleshooting, problem management, and configuration management.
• Strong interpersonal and communication skills for partnering with key stakeholders.
• Fluent spoken and written English required.

Nice to have

• Experience with regulatory audits.

Culture & Benefits

• Full-time position supporting the startup of a new QC facility in Singapore.
• Work involves collaboration with QC operations, Digital, and global hirify.global teams.
• hirify.global states that it provides equal opportunities regardless of personal background or identity.