QC 系统管理员

Responsible1.Responsible for QC computerize system management (e.g. LIMS, LES， LabX), including system configuration, maintenance, audit trail review.2. Lead or participate the quality activities such as change control, deviation investigation, CAPA of laboratory system.3. Technical support and troubleshooting provide for QC end users.4. Collaborate with other department and suppliers to diagnose and solve complex system issues.5. Ensure that all QC computerized system comply with GMP regulations. Lead or support the CSV activities of computerized system. Assist in the deployment, upgrade, and validation of a new systems/new versions.6. Assist in responding to client audits and external official audits (such as FDA, EMA).7.Provied training and document management for the users.Requirement:

1. 01

   Bachelor or master degree with major in Biology, Chemistry or Pharmaceutical analysis field.2. At least 5 years of GMP experience, at least 2 years of team management experience.3.Familiar with at least one of the LIMS, Empower, LES and other E-Systems in QC.4.Deep understanding of GAMP5 guidelines, 21CFR Part 11, EU GMP Annex11, data integrity and other regulations.5.Familier with Environment monitor in QC is

.6.Good computer operation skill (intermediate level in Microsoft Word, Excel, PowerPoint, Power BI, Minitab etc.7.Fluent in writing and reading in both Chinese and English.8.Critical thinking, scientific reasoning and problem solving skills, Excellent communication skills, teamwork abilities, and stress resistance are necessary.