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[Factory 1] Dedicated Quality Compliance Officer (Microbiology/ Chemical/ Pharmacy) - Urgent!

Nơi làm việc:Bình Dương
Số lượng: 9
Ngày hết hạn:28/6/2026

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 TIN KHÁC:

  • 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

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