Kerja Sepenuh Masa QC Analytical - CSV Engineer, Gaji tinggi MYR 24,000 di Regional Energy Pte Ltd Johor - Maukerja

Role Purpose

We are looking for two detail-oriented QC Analytical / CSV Engineers to join our Quality team. In this critical role, you will execute rigorous analytical testing to guarantee the quality, safety, and efficacy of our vaccine products. You will play a vital part during both the validation phases and ongoing commercial production, ensuring that all laboratory processes and systems meet stringent regulatory standards.

Key Responsibilities

• Analytical Testing: Execute comprehensive in-process testing, raw material testing, and stability testing to ensure product integrity.
• Batch Release: Perform critical batch release testing for Process Performance Qualification (PPQ) batches, adhering to strict production timelines.
• Method Validation: Conduct and document analytical method validations and transfers to ensure laboratory techniques are robust and reproducible.
• CSV Compliance: Oversee the validation of laboratory computer systems (CSV), ensuring that software and automated analytical instruments are compliant with data integrity and regulatory requirements (e.g., 21 CFR Part 11).
• Laboratory Support: Maintain analytical instrumentation and provide technical expertise for troubleshooting complex laboratory assays.

Key Deliverables

• Accurate and timely issuance of Test Results and Certificates of Analysis (COA).
• Comprehensive Analytical Method Validation Reports.
• Detailed Stability and Environmental Monitoring Reports to support product shelf-life and facility compliance.
• Validation documentation for laboratory computer systems and software.

Required Skills & Qualifications

• Education: Bachelor’s or Master’s degree in Chemistry, Microbiology, or a related scientific discipline.
• Experience: Proven hands-on experience with analytical instrumentation (e.g., HPLC, GC, UV-Vis, or PCR) in a regulated laboratory environment.
• Regulatory Knowledge: A deep and practical understanding of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Technical Writing: Ability to draft clear, concise, and compliant validation protocols and technical reports.
• CSV Awareness: Knowledge of Computer Systems Validation (CSV) principles within a Quality Control setting is highly preferred.

Work location : SINGAPORE

Pay: RM18,000.00 - RM24,000.00 per month

Work Location: In person