Dedicated Quality Compliance Officer (GMP / Aseptic / Sterile Pharmaceutical Manufacturing)

URGENT HIRING | 11 OPENINGS

Job purpose

This role is responsible for monitoring GMP compliance in the factory to make sure production activities, documentation, and systems follow approved procedures and quality requirements.

Depending on your background and experience, you may focus on one of the following areas:

• Aseptic compliance monitoring
• Data integrity & GMP documentation review
• Environmental monitoring / microbiology oversight
• Cleaning, disinfection & contamination control

1. Aseptic Compliance Monitoring (6 headcounts)

• Observe production activities in GMP/sterile areas during operations
• Check operator practices, gowning, material flow, and compliance with SOPs
• Identify and report any GMP or aseptic compliance issues
• Support routine and surprise inspections in GMP areas

2.     Data Integrity Oversight & System Compliance - (1 headcounts)

• Review batch records, logbooks, and related GMP documents
• Cross-check records with actual activities and system data
• Ensure records follow ALCOA+ principles
• Review audit trails and identify abnormal data or documentation issues

3. Environmental Monitoring & Microbiology Oversight  - (2 headcounts)

• Observe environmental sampling and microbiology-related activities
• Review environmental monitoring results and identify unusual trends
• Support investigation of contamination risks or out-of-limit results

4. Cleaning, Disinfection & Contamination Control (CCS Oversight) - (1 headcount)

• Check whether cleaning and disinfection are performed according to approved procedures
• Verify records, disinfectant use, contact time, and cleaning practices
• Identify gaps or risks that may impact product quality

5.   Observation Reporting, Escalation & CAPA - (1 headcount)

• Record observations clearly and on time
• Escalate critical issues to management immediately
• Participate in deviation investigation, root cause analysis, and CAPA follow-up
• Support inspection readiness
• Keep observation records and compliance reports well organized and inspection-ready
• Support internal audits and regulatory inspections when required

• Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or related fields
• Experience in GMP / pharmaceutical manufacturing is preferred
• Experience in QA, QC, Microbiology, Compliance, or Data Integrity is a plus
• Careful, detail-oriented, and confident in reviewing records and observing manufacturing activities
• Good communication, reporting, and Microsoft Office skills
• Willing to work in shifts when required

• Bằng cấp: Đại học
• Hình thức: Nhân viên chính thức
• Phụ cấp khác:

  Company bus from HCMC to Factory
  Parking fee
  Meal allowance

• Thời gian thử việc: 2 months of probation with full salary
• Cơ hội huấn luyện: A2E skill training
• Độ tuổi: 22 - 25
• Đồng nghiệp: Friendly, supportive
• Phúc lợi:

  Japanese Health Insurance for Staffs over 2 years contribution
  Company trip, Team building activities
  Holiday events

• Ngày nghỉ:

  - 15 working days: from full 1 year to less than 3 years;
  - 16 working days: from full 3 years to less than 7 years;
  - 22 working days: from full 7 years or more to less than 37 years.

• Lương: Cạnh tranh