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.

1.   Observation Reporting, Escalation & CAPA 

Real-Time Observation Documentation:

• Record all observations in real time using standardised controlled forms.
• Classify deviations: Critical (immediate escalation) / Major (within 24 hrs) / Minor (routine review).
• Notify Management of all critical issues without delay.

Investigation & CAPA Participation:

• Participate in root cause analysis (RCA) for identified deviations.
• Review CAPA plans, verify implementation, and monitor for recurrence.
• Support CAPA effectiveness checks and report findings to management.

2.   Inspection Readiness 

• Maintain observation records, reports, and forms in a continuously retrievable, inspection-ready state.
• Support FDA and other regulatory authority inspectors during inspections.
• Provide records and evidence of DQCT oversight activities upon request.

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.