Dedicated Quality Compliance Officer (GMP / Aseptic / Sterile Pharmaceutical Manufacturing)

URGENT HIRING | 11 OPENINGS
Job purpose
This role is responsible for monitoring GMP compliance in the factory to make sure production activities, documentation, and systems follow approved procedures and quality requirements.
Depending on your background and experience, you may focus on one of the following areas:
Aseptic compliance monitoring
Data integrity & GMP documentation review
Environmental monitoring / microbiology oversight
Cleaning, disinfection & contamination control
1. Aseptic Compliance Monitoring (6 headcounts)
Observe production activities in GMP/sterile areas during operations
Check operator practices, gowning, material flow, and compliance with SOPs
Identify and report any GMP or aseptic compliance issues
Support routine and surprise inspections in GMP areas
2.     Data Integrity Oversight & System Compliance - (1 headcounts)
Review batch records, logbooks, and related GMP documents
Cross-check records with actual activities and system data
Ensure records follow
ALCOA+ principles
Review audit trails and identify abnormal data or documentation issues
3. Environmental Monitoring & Microbiology Oversight  - (2 headcounts)
Observe environmental sampling and microbiology-related activities
Review environmental monitoring results and identify unusual trends
Support investigation of contamination risks or out-of-limit results
4. Cleaning, Disinfection & Contamination Control (CCS Oversight) - (1 headcount)
Check whether cleaning and disinfection are performed according to approved procedures
Verify records, disinfectant use, contact time, and cleaning practices
Identify gaps or risks that may impact product quality
5. Observation Reporting, Escalation & CAPA - (1 headcount)
Record observations clearly and on time
Escalate critical issues to management immediately
Participate in deviation investigation, root cause analysis, and CAPA follow-up
Support inspection readiness
Keep observation records and compliance reports well organized and inspection-ready
Support internal audits and regulatory inspections when required
Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or related fields
Experience in GMP / pharmaceutical manufacturing is preferred
Experience in QA, QC, Microbiology, Compliance, or Data Integrity is a plus
Careful, detail-oriented, and confident in reviewing records and observing manufacturing activities
Good communication, reporting, and Microsoft Office skills
Willing to work in shifts when required
Ngành nghề: Dược phẩm/ Hóa Mỹ Phẩm, Quản lý chất lượng (QA/QC), Sản xuất / Vận hành sản xuất
Kinh nghiệm: 1 Năm
Cấp bậc: Nhân viên
Hình thức: Nhân viên chính thức
Địa điểm: Bình Dương