QC Validation Lead
Core
Lead and coordinate all validation activities within the Quality Control department to ensure laboratory operations, analytical methods, equipment, and computerized systems perform as intended and remain compliant with regulatory requirements.
Role type
Senior IC QC Validation Lead
Builds
Validated analytical methods, qualified laboratory equipment, and compliant computerized systems for consumer healthcare products
Domain
Consumer Healthcare / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation, cleaning validation, equipment qualification, computerized system validation (CSV), regulatory compliance (GMP, FDA, EMA, ISO), data integrity, leadership, project management
Preferred skills
Experience with Waters Empower chromatography data system, analytical method transfer, pharmacopoeial updates
Technologies
Waters Empower
Responsibilities
Lead development and execution of Analytical Method Validation (AMV) protocols and reports; Conduct cleaning validation analytical testing and laboratory equipment qualification; Ensure implementation and compliance of Computerized System Validation (CSV); Support analytical method transfer activities and pharmacopoeial updates; Drive continuous improvement initiatives related to validation and data integrity
Seniority
Senior, hands-on IC
