Singapore Job Openings
PM ASIA PROJECT SERVICES PTE. LTD.
CQV Engineer
Singapore
FULL TIME & CONTRACT
September 20, 2024
Your day to day role would involve the following activities:
- Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
- The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
- Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Can lead investigation revolving around discrepancies identified during qualification activities.
- Experience in commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
- Experience in leading daily validation meetings with cross functional in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
- Work experience in Pharmaceutical or Bio Pharma industries
- Hands on validation execution experience
- Review validation documents
- Write validation protocols and reports
- Able to execute activities in c GMP environment, including cleanrooms or technical areas.
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