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.

Data Integrity Oversight & System Compliance

GMP Records Verification:

• Cross-reference batch production records (BPR), log books, and actual instrument/system data.
• Ensure all GMP records comply with ALCOA+ principles: Attributable, Legible, Contemporaneously recorded, Original, Accurate (plus Complete, Consistent, Enduring, and Available).
• Cross-check recorded data against actual on-floor activities.

Audit Trail & Electronic Systems Review:

• Review audit trails of LIMS, MES, SCADA, and other GMP data systems.
• Detect indicators such as back-dated entries, unauthorised corrections, or missing data.
• Verify system access controls and data modification history.

DI Investigation & Training:

• Support Data Integrity awareness training and education for GMP personnel.
• Initiate a formal Data Integrity investigation within 24 hours of detecting a breach.

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.