MÔ TẢ CÔNG VIỆC:
1. Aseptic Compliance Monitoring (6 headcounts)
Real-Time Floor Monitoring:
- Perform continuous observation within sterile areas across all production shifts.
- Monitor aseptic techniques and interventions, operator behavior and gowning practices, material and personnel flow, and cleanroom discipline.
- Verify adherence to approved procedures and GMP requirements.
CCTV Review & Documentation:
- Review CCTV footage of critical operations and interventions.
- Cross-reference documented records against observed actual practices.
- Record all aseptic deviations immediately and in full detail.
Media Fill & Training Support:
- Observe and document activities during aseptic process simulations (media fills).
- Provide feedback to operator training programmes to improve aseptic behaviour.
- Perform routine and unannounced inspections in GMP areas.
2. Data Integrity Oversight & System Compliance (2 headcounts)
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.
3. Environmental Monitoring & Microbiology Oversight (1 headcount)
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.
4. Cleaning, Disinfection & Contamination Control (CCS Oversight) (1 headcount)
Execution Oversight:
- Oversee execution of cleaning and disinfection procedures against approved SOPs.
- Verify disinfectant contact times and confirm disinfection effectiveness.
- Ensure disinfectant rotation is performed correctly and on schedule.
- Audit cleaning records versus actual practices (including CCTV verification).
Contamination Control:
- Ensure adherence to the Contamination Control Strategy (CCS) across all operations.
- Evaluate cleaning validation results and assess residue risk.
- Identify gaps in cleaning effectiveness and recommend improvements.
- Immediately escalate cleaning failures and recommend production hold when necessary.
5. Observation Reporting, Escalation & CAPA (1 headcount)
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.
6. 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.
YÊU CẦU CÔNG VIỆC:
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.
THÔNG :
- Thử việc: 2 months of probation with full salary
- Thời gian làm việc: 44 hours/week
- Cơ hội huấn luyện:
A2E skill training
Pre-mortems
Prioritization
Problem solving
Owner's mindset
Idea generation
Coaching
Influencing
Courageous conversations
Effective communication
Presenting with impact
Closed-loop conversations
Creating business value
Effective meetings
Effective emailing
Organizational health
- Đồng nghiệp: Friendly, supportive
- 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.
- Phúc lợi:
Japanese Health Insurance for Staffs over 2 years contribution
Company trip, Team building activities
Holiday events
- Phụ cấp khác :
Company bus from HCMC to Factory
Parking fee
Meal allowance