Quality and Validation Specialist

Goals and deliverables

• Validation specialist with 10 15 years experience in pharmaceutical and/or FMCG environments
• Direct experience designing and executing validation protocols (IQ/OQ/PQ)
• Proven experience writing validation reports and core validation documentation
• Experience developing and maintaining validation standards, SOPs, and validation master plans
• Demonstrated work under cGMP, FDA, WHO, ISO, and GAMP 5 requirements in regulated environments
• Proven track record leading and managing site-level or multi-site validation projects (planning, execution, documentation)

Mandatory Hands-on Experience In

• Process validation
• Cleaning validation
• Equipment qualification
• Utility validation
• Laboratory/analytical method validation
• Computer system validation (CSV)