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QC Engineer (Analytical Systems CSV)
Unison GroupKuala Lumpur, Federal Territory of Kuala Lumpur, MY1 hari lalu
Jenis pekerjaan
- Quick Apply
Penerangan pekerjaanBachelor’s degree in Chemistry, Life Sciences, Engineering, or related discipline. 5–10 years’ experience in analytical instrument / equipment CSV within pharmaceutical / biotech QC labs. Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11 . Hands-on experience with microbiology analytical equipment is an advantage. Familiarity with electronic validation tools (e.g., Kneat ) is preferred. Strong documentation, troubleshooting, and cross-functional collaboration skills.
Role Overview
We are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments / equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.
Key Responsibilities
- Lead CSV activities for analytical equipment or instruments and lab computerized systems (e.g., HPLC, GC, UV, LIMS, Empower).
- Develop and execute validation deliverables : URS, risk assessments, IQ / OQ / PQ, RTM, and summary reports.
- Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity controls.
- Evaluate and validate audit trails, security settings, and user access controls.
- Support integration between instrument, PC, network, and enterprise systems.
- Draft, review, and maintain SOPs, validation documentation, and audit readiness materials.
- Contribute to lifecycle management of systems including periodic reviews, upgrades, and change control.
- Collaborate with QA, QC, and IT to support inspection readiness and continuous improvement.
Requirements
Requirements
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System Engineer • Kuala Lumpur, Federal Territory of Kuala Lumpur, MY