Tuyển dụng [Factory 1] Chief of Dedicated Quality Compliance tại Bình Dương

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.
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 2 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.
Ngành nghề: Dược phẩm/ Hóa Mỹ Phẩm, Quản lý chất lượng (QA/QC), Sản xuất / Vận hành sản xuất
Kinh nghiệm: 5 Năm
Cấp bậc: Quản lý
Hình thức: Nhân viên chính thức
Địa điểm: Bình Dương