Quality Control Qualification Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 85,000 - 105,000; Full time

Job summary

COALESCE MANAGEMENT CONSULTING PTE. LIMITED is seeking a QC Qualification Engineer to support the implementation and maintenance of QC GxP systems and to qualify environmental monitoring particle counters and related laboratory computerized systems.

You will ensure qualification documentation and system support comply with company standards, regulatory guidance, and data integrity expectations. Experience with IQ/OQ protocols and cross-functional collaboration is essential.

Qualifications

• Requires degree or diploma in Engineering, Life Sciences, or related field.
• Experience in equipment qualification or computerized system validation in GMP environments.
• Experience qualifying environmental monitoring particle counters preferred.
• Knowledge of IQ/OQ protocols, exception management, and qualification reports.

Responsibilities

• Write and/or execute IQ and OQ protocols for environmental monitoring systems.
• Document qualification exceptions and provide reports.
• Prepare Qualification Summary Reports against protocols and acceptance criteria.
• Write and maintain QC system procedures and SOPs.
• Provide system administration support and user access management.
• Coordinate qualification activities with cross-functional teams to meet timelines.
• Ensure compliance with GxP, Good Documentation Practices, and regulatory requirements.

Skills

IQ/OQ protocols

Documentation

Data integrity

Cross-functional

Troubleshooting

User access administration

Education

Engineering degree

Job description

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 ensures qualification 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.