Mô tả công việc
1. Operational Management of DQCT
• 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
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 systems is 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
Quyền lợi
Chăm sóc sức khoẻ
Japanese Health Insurance for Staffs over 2 years contribution
Nghỉ phép có lương
Allowance, Annual leave, bonus, Training...
Hoạt động nhóm
Company trip, Team building activities
Holiday events
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