Quality Systems Associate Specialist (Pharma/Biotech)
NUSANTARA PRIME CONSULTING PTE. LTD.
Singapore
Gmp document control and lifecycle management
Qa training coordination and record maintenance
Supplier qualification and quality agreement drafting
The incumbent will support the Quality Systems team in establishing and maintaining an effective Quality Management System aligned with GMP requirements
Job Summary
The incumbent will support the Quality Systems team in establishing and maintaining an effective Quality Management System aligned with GMP requirements.
Key responsibilities include managing the full lifecycle of GMP documentation, coordinating employee training activities, and supporting supplier qualification processes.
The role involves organizing site-wide initiatives to promote Quality Culture and Data Integrity while assisting in periodic reviews of key quality metrics.
Matching Summary
Match Score: 85
The incumbent will support the Quality Systems team in establishing and maintaining an effective Quality Management System aligned with GMP requirements.
Skills & Requirements
Must-have
GMP document control and lifecycle management
QA training coordination and record maintenance
Supplier qualification and quality agreement drafting
Nice-to-have
Experience with MasterControl or TrackWise systems
Knowledge of FDA, EMA, HSA, and PIC/S regulations
Ability to conduct on-site supplier audits
Key Requirements
Bachelor degree in Chemistry, Biology, or related field
1-2 years experience in biopharmaceutical QA function