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[Factory 1] DQCO - Data Integrity Oversight & System Compliance Officer (Pharmacy/ Biotech/ Chemical)

10.6–19.6 triệu · tham khảo📍 Bình DươngKinh nghiệmỨng tuyển ngay →

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Mô tả 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.

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[Factory 1] DQCO - Data Integrity Oversight & System Compliance Officer (Pharmacy/ Biotech/ Chemical)10.6–19.6 triệu · tham khảo · 📍 Bình Dương
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