The role involves maintaining and improving the Quality Management System while ensuring strict adherence to GMP, PIC/S, ICH, ASEAN, and FDA guidelines
Job Summary
The role involves maintaining and improving the Quality Management System while ensuring strict adherence to GMP, PIC/S, ICH, ASEAN, and FDA guidelines.
Responsibilities include managing critical quality processes such as change control, deviations, CAPA, investigations, product recalls, and customer complaints.
Candidates will support validation activities, stability programs, and the review of packaging artwork in a 5-day office-based setting.
Matching Summary
Match Score: 85
The role involves maintaining and improving the Quality Management System while ensuring strict adherence to GMP, PIC/S, ICH, ASEAN, and FDA guidelines.
Skills & Requirements
Must-have
Maintain Quality Management System
Handle QA documentation control
Ensure GMP compliance
Manage change control and deviations
Handle customer complaints and recalls
Nice-to-have
Support validation programs
Experience with stability programs
Packaging artwork review skills
Key Requirements
Knowledge of GMP / PIC/S / ICH / ASEAN / FDA guidelines
Experience with QA documentation control (SOPs, manuals)