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[Factory 1] Dedicated Quality Compliance Group Leader

Nơi làm việc:Bình Dương
Số lượng: 1
Ngày hết hạn:28/6/2026

MÔ TẢ CÔNG VIỆC:

1.     Operational Management of DQCT

Day-to-Day Oversight:

  • Manage and coordinate the daily operations of all DQCO Officers across shifts.
  • Review all deviation reports, observation logs, and escalation notifications produced by officers.
  • Ensure DQCT shift coverage is maintained across all production schedules.
  • Conduct daily/weekly briefings with officers to review findings, escalations, and priorities.

Performance Management:

  • Monitor individual officer performance against KPIs and compliance targets.
  • Identify skill gaps and coordinate targeted training and development activities.
  • Conduct regular one-to-one reviews and formal performance assessments.

 

2.     Compliance Oversight & Escalation

  • Review all critical deviation reports and ensure timely escalation to the Head of DQCT and relevant management.
  • Participate in root cause analysis (RCA) for significant compliance findings.
  • Review and monitor CAPA plans for DQCT-identified deviations and track implementation effectiveness.
  • Approve final observation reports before submission to QA and management.

 

3.     Inspection Readiness & Regulatory Support

  • Ensure all DQCT records, observation forms, and reports are maintained in a continuously audit-ready state.
  • Serve as the primary DQCT point of contact during internal and external regulatory inspections.
  • Coordinate DQCT contributions to regulatory inspection preparation and response activities.

 

4.     Reporting & Trend Analysis

  • Review compliance trend reports, KPI dashboards, and management review inputs produced by the DQC-REA Officer.
  • Present DQCT performance summaries to the Head of DQCT and site senior management.
  • Identify systemic issues and drive targeted improvement initiatives across DQCT functions.

 

5.     Cross-Functional Coordination

  • Act as the primary operational interface between DQCT and site QA, QC, Production, Engineering, and Microbiology teams.
  • Coordinate cross-functional investigations, CAPA implementation, and compliance improvement projects.
  • Facilitate effective communication between DQCT officers and department heads.

YÊU CẦU CÔNG VIỆC:

Education

  • Bachelor's degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or a related science discipline.
  • Advanced degree or specialized GMP management qualification is preferred.

Work Experience

  • Minimum 3 years of experience in a GMP-regulated pharmaceutical environment, with at least 1 years in a team leadership or management role.
  • Proven experience managing compliance oversight teams in sterile or aseptic manufacturing is strongly preferred.
  • Demonstrated experience managing regulatory inspections (FDA, EMA, WHO, or local authority).

Technical Knowledge

  • Comprehensive knowledge of cGMP: 21 CFR Part 210/211, EU GMP, WHO GMP.
  • Strong expertise in Data Integrity (ALCOA+), Contamination Control Strategy, aseptic processing, and Environmental Monitoring.
  • Proficiency in LIMS and GMP electronic systemsis preferred.
  • Knowledge of ICH Q9 (Quality Risk Management) and RCA methodologies.

Skills

  • Strong leadership, team management, and people development skills.
  • Advanced analytical, report writing, and communication skills in Vietnamese and English.
  • Proficient in Microsoft Office; Power BI / advanced Excel is an advantage.
  • Audit management and inspection coordination skills.

Personal Attributes

  • High integrity, independent judgment, unwavering under production schedule pressure.
  • Strong organizational skills with ability to manage multiple priorities under pressure.
  • 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
  • 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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