[QA] Validation 경력사원 채용
Core
Managing validation activities for pharmaceutical manufacturing processes, facilities, and equipment in compliance with GxP regulations.
Role type
Senior Quality Assurance Validation Engineer
Builds
Validated manufacturing processes, facilities, and equipment for pharmaceutical production
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Note: Corrected to 'physical/clinical work' based on the 'physical/clinical work' option in the prompt, but the role is actually 'physical/clinical work' in the sense of manufacturing validation. Wait, the prompt options are: 'production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work'. The role is about validating physical processes and equipment. 'physical/clinical work' is the closest fit among the options provided, although 'infrastructure' might also apply. Let's stick to the prompt's specific list. The role involves validating physical equipment and processes. 'physical/clinical work' is the only option that fits 'physical' work. However, 'infrastructure' is also valid. Given the list, 'physical/clinical work' is the intended category for hands-on validation of physical systems in this context, or perhaps 'infrastructure'. Let's re-read the prompt options. 'physical/clinical work' usually implies medical/clinical trials or physical therapy. This role is industrial validation. 'infrastructure' fits better for equipment/facility validation. But the prompt says 'physical/clinical work'. Let's assume the prompt's list is exhaustive and 'physical/clinical work' is the catch-all for physical validation tasks in this specific schema, or 'infrastructure'. Actually, looking at the list again: 'production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work'. This role is about validating the 'infrastructure' (Facility/Utilities/Equipment) and 'processes'. 'infrastructure' is the best fit from the list for equipment/facility validation. 'physical/clinical work' is likely for clinical trials. I will use 'infrastructure' as it covers Facility/Utilities/Equipment Qualification and Process Validation of manufacturing lines.
Required skills
Process validation, Cleaning validation, Qualification (Facility/Utilities/Equipment), GxP compliance, Vendor management, URS/DQ/FAT review, Project C&Q execution
Preferred skills
FDA/EMA audit experience, English communication (Fluent), Chemistry/Biology/Engineering background
Technologies
GxP systems, Validation Master Plan (VMP) tools, MFT (Manufacturing Execution System) tools
Responsibilities
Manage Validation Master Plan (VMP), Execute Process Validation and Cleaning Validation, Perform Facility/Utilities/Equipment Qualification, Support CPV and PLI, Review URS/DQ/FAT and manage third-party vendors, Execute CSV for GxP systems
Seniority
Mid-Senior, hands-on IC
