6 months contract Validation Engineer (Pharma)
Recruit Express Pte Ltd| Date Posted: 15-Feb-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
Entry Level, Experienced
Diploma, Bachelor's / Honours
- 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,
- Experienced 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 coordinate the 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)
- Regular progress report of project deliverables to supervisor/project lead
- Any other duties as assigned by supervisor/designated person.
- Min Diploma/Degree in Science or Engineering or any related courses
- Proficient in technical write up of validation lifecycle documentation
- Knowledge in validation aspect under GMP environment
- Min 2 years of validation experience
- Able to start work immediately
Interested applicants please send your resume to [Click Here to Email Your Resume]
Huang Jingsheng Kevyn (R1333338)
RECRUIT EXPRESS PTE LTD (99C4599)
Recruit Express Pte Ltd