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

Ngành nghề: Dược phẩm/ Hóa Mỹ Phẩm, Thực phẩm & Đồ uống, Quản lý chất lượng (QA/QC)

Kinh nghiệm: 1 Năm

Cấp bậc: Nhân viên

Hình thức: Nhân viên chính thức

Địa điểm: Hồ Chí Minh

• 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