Team Lead - Visual Inspection
Core
End-to-end management of drug product visual inspection operations (manual and automated) ensuring compliance with cGMP norms and QMS elements.
Role type
Team Lead, Visual Inspection (Biologics)
Builds
Visual inspection systems and processes for biosimilar drug products
Domain
Biopharmaceuticals / Biosimilars
Required skills
cGMP compliance, QMS management, shift allocation, optical inspection planning, process validation, clean room protocols, project qualification (URS, FAT, SAT), staff training
Preferred skills
None stated
Technologies
None stated
Responsibilities
Coordinate team shift allocation and leave approvals; Monitor and close QMS elements (Change controls, CAPA, incident management, SIR, market complaints); Review audit points; Plan optical inspection operations; Lead visual inspection projects (URS, FAT, SAT, equipment qualification); Review and execute process validation protocols; Review and revise batch production records and SOPs; Ensure clean room behavior compliance; Identify unsafe conditions; Coordinate packaging qualification activities; Train staff on cGMP operations.
Seniority
Mid-level Team Lead
