PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space.
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.
We would like to hear from candidates who have:
- 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 BioPharma industries
- Hands on validation execution experience
- Review validation documents
- Write validation protocols and reports
- Able to execute activities in cGMP environment, including cleanrooms or technical areas.
