Validation Officer
Core
Coordinate validation and qualification activities and maintain compliant quality documentation for a manufacturer in complementary medicine and food.
Role type
Validation & Quality Systems Specialist
Builds
Validation Master Plans, equipment qualification (IQ/OQ/PQ), process/cleaning validation, SOPs, and controlled quality documentation
Domain
Pharmaceutical/Complementary medicine and food manufacturing
Required skills
Validation coordination, equipment qualification, document control, SOP development, risk assessment, change control management, deviation investigation, CAPA management, technical writing
Preferred skills
GMP-regulated manufacturing experience, TGA or PIC/S GMP requirements knowledge, computerised-system validation, temperature mapping, method validation, facility and utility qualification
Technologies
IQ/OQ/PQ protocols, Validation Master Plan, CAPA systems, document control systems
Responsibilities
Coordinate validation schedules and registers, prepare and review validation protocols and reports, manage equipment qualification lifecycle, assess validation requirements from change controls, manage controlled documents and version control, draft and update SOPs and work instructions, support validation-related deviations and investigations
Seniority
Mid-level, hands-on specialist
