The DQCO performs independent, real-time oversight of all GMP activities at the facility, without direct involvement in production or routine quality release (QA release / QC). The role ensures that aseptic compliance, data integrity, environmental monitoring, and contamination control are maintained to the highest regulatory standards across all production shifts.

Environmental Monitoring & Microbiology Oversight 

Microbiology Operations Observation:

• Observe environmental sampling procedures (Active Air Sampling, Settle Plate, Contact Plate, Personnel Monitoring).
• Monitor plate reading, incubation procedures, and Growth Promotion Testing.
• Detect analyst bias or manipulation in the interpretation of environmental monitoring (EM) results.

EM Data Review:

• Perform daily review of viable and non-viable environmental monitoring data.
• Verify compliance with Alert Limits and Action Limits.
• Trend contamination data and detect early adverse signals.
• Initiate immediate investigation for excursions and atypical findings.

Contamination Investigation Support:

• Participate in contamination incident investigations and source identification.
• Recommend investigation initiation and batch impact assessment.

Education

• Bachelor's degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or a related science discipline.
• Postgraduate qualification or specialised GMP certification is an advantage.

Work Experience

• Experience in a GMP environment; sterile manufacturing experience is strongly preferred.
• Experience in Aseptic oversight, Environmental Monitoring, or QA/QC roles is a significant advantage.

Technical Knowledge

• cGMP: 21 CFR Part 210/211, EU GMP, WHO GMP.
• Data Integrity – ALCOA+ (FDA, MHRA, WHO Guidance).
• Aseptic Process Simulation (Media Fill).
• ICH Q9 (Quality Risk Management) and root cause investigation tools (RCA, 5-Why, Fishbone).

Skills

• Detail observation skills, accurate and contemporaneous documentation.
• Audit skills, effective questioning, and risk assessment.
• Written reporting skills in both Vietnamese and English.
• Teamwork and cross-departmental communication skills.
• Proficient in Microsoft Office; Power BI / advanced Excel is an advantage.

Personal Attributes

• High integrity, independent judgment, unwavering under production schedule pressure.
• Meticulous, critical thinking, and strong compliance mindset.
• Willing to work shift-based schedules including nights and weekends as required.