QA Specialist (Pharma)

Mô tả Công việc
JOB PURPOSE : Perform and monitor tasks related to the system aspect of QA department; support other tasks of QA department to ensure all processes and products reach GMP and group requirements, which are defined in global documents and guidelines.
KEY ACCOUNTABILITIES:
1.Self-Inspection & audit/ inspection
Develop and execute self-inspection plans for GMP & Halal in accordance with company procedures.
Lead regulatory inspection preparation and inspection: Global Quality Audit, GMP inspection by DAV, TGA, GMP for cosmetics by DAV, Halal by LPOM MUI, HS..., Track and follow up on corrective and preventive actions (CAPA).
Lead GMP guidance assessments and Implementation Follow-up.
2.Quality System Management
Quality Performance Monitoring
Lead QMI (Quality Management Indicators) and QCMA (Quality Control Maturity Assessment) programs
Monitor, summarize, and report results to managers
Lead the Directive implementation program at site
Ensure compliance between internal procedures and global quality documents
3.Others
Take the Local Admin role for CMS system and back up Local Admin for Event, CAPA, ILI (Investigation & Learning from Incidents), and Change Control (CC) systems
Support the implementation of quality improvement initiatives within the site
Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
Support other activities when needed
Compliance with HSE requirements