Job Description
- Lead QA oversight for computer system validation (CSV) activities ensuring compliance with cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 standards
- Review user requirement specifications (URS) and risk assessments to ensure thorough validation planning and risk mitigation
- Oversee installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities to verify system functionality and compliance
- Ensure data integrity by applying ALCOA+ principles and managing change controls throughout validation and implementation processes
- Act as the QA representative for system upgrades and new system implementations, collaborating closely with IT, Validation, and Engineering teams to drive project success
- Apply strong CSV and QA project management skills to deliver compliant and efficient validation outcomes within a GMP environment, preferably in pharmaceutical or biologics sectors
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