Senior QA Validation Specialist

7 days ago

Singapore PSC BIOTECH PTE. LTD. Full time

Provide validation strategy and QA oversight on computer system validation (lab equipment, process equipment, IT, automation system - DeltaV, PEMS, AMS) and equipment/system validation (vessels, fermenter, washing machine, washing cabinet, chambers, Isolator) and SIP
- Review and approve validation protocols and reports including validation lifecycle documents, but not limited to the following: URS, FS, SLIA, RA, IQ, OQ, PQ, RTM
- Review and approve change control and provide validation impact assessment for changes
- Review and approve deviation and CAPA. Be part of the core member for the deviation investigation and RCA
- Review and approve SOPs, if required

**Requirements**:

- Bachelor’s Degree in Chemical Engineering or equivalent
- At least **5 years of experience **in Computer System Validation (CSV) and Equipment Validation
- Relevant **QA oversight experience **in CSV and Equipment Validation
- Be familiar with validation life-cycle documents such as IQ, OQ, PQ etc
- To have sound knowledge and experience in Data Integrity principle and practice
- To have sound knowledge and be familiar with regulatory requirements and industry practices on validation
- **Must be comfortable with contract basis role

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