Tuyển dụng QA Specialist (Pharma)

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
• Graduated from a university with a major in
• Pharmacy, Chemistry, or a related field.
• At least 6 months experience and used to work in quality assurance systems or GMP sites
• Organized, planning and time management
• Two-way communication, adaptability to multi-culture environment.
• Fluent English - 4 skills
• Using Word, Excel, Power Point