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 university and have knowledge of operations and pharmaceutical production.
• Has 3 -5 years experience and used to work in quality assurance systems or GMP sites 
• Perform capacity to understand key business issues which impact quality operations and the impact of quality on commercial operations.
• Knowledge of GMP and HSE systems.
• Organized, planning and time management
• Two-way communication, adaptability to multi-culture environment.
• Fluent English - 4 skills
• Using Word, Excel, Power Point