全职 Quality Control Qualification Engineer 工作, 薪水 up to SGD 6,000, COALESCE MANAGEMENT CONSULTING PTE. LIMITED 公司招聘中 - Ricebowl

We are looking for a QC Qualification Engineer to support the implementation and maintenance of QC GxP systems, with primary responsibility for qualifying environmentalmonitoring particle counters and related laboratory computerized systems and electronic equipment. The role ensuresqualification documentation and system support comply with company standards, regulatory guidance, and data integrity expectations.

Key Responsibilities:

• Write and/or execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for environmental monitoring particle counters and other QC laboratory computerized systems and electronic equipment.
• Document qualification exceptions and discrepancies, support investigations, and author clear exception reports.
• Prepare Qualification Summary Reports for QC equipment, confirming completion against approved protocols and acceptance criteria.
• Author and maintain QC system procedures, including administrative SOPs, configuration specifications, and supporting system documentation.
• Provide user administration support for laboratory systems, including access requests, troubleshooting, problem-solving, and issue resolution.
• Partner with QC to conduct data integrity risk assessments and identify appropriate procedural and technical controls.
• Collaborate with QC, QA, Engineering, IT, and vendors to coordinate qualification activities and close actions in a timely manner.
Ensure qualification activities and records comply with GxP, Good Documentation Practices, site standards, and regulatory requirements.

Requirements:

• Degree or diploma in Engineering, Life Sciences, Pharmaceutical Science, Biotechnology, or a related discipline.
• Hands-on experience in equipment qualification or computerized system validation within a pharmaceutical, biotechnology, or GMP-regulated environment.
• Direct experience qualifying environmental monitoring particle counters is strongly preferred.
• Working knowledge of IQ/OQ protocols, exception management, qualification reports, SOPs, and configuration specifications.
• Understanding of data integrity principles, user access administration, and laboratory computerized systems.
• Strong technical writing, troubleshooting, communication, and cross-functional stakeholder-management skills