Qualification & Validation - Life Sciences
Core
Coordinate and execute the validation cycle for pharmaceutical production projects, ensuring compliance with GMP standards and project timelines.
Role type
Senior IC Quality Validation Consultant
Builds
Validated production systems and processes for pharmaceutical partners
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP/BPF documentation, Risk assessment, Functional/Design Specifications writing, Validation protocols (URS/FAT/SAT/IQ/OQ/PQ), Deviation/CAPA management, Training & coaching
Preferred skills
Engineering or Bio-engineering background, Pharmaceutical production process knowledge, English fluency
Technologies
GMP documentation tools, Risk assessment frameworks
Responsibilities
Represent the Validation department on projects, design validation strategies, coordinate project planning with stakeholders, evaluate risks, write specifications and protocols, analyze test results, develop training, manage deviations and CAPA
Seniority
Mid-Senior, hands-on IC
