Visual Inspection Subject Matter Expert, Visp e/v/e/r/y/o/n/e
Core
Ensure visual inspection of parenteral medicinal products is performed in a regulatory-compliant, robust, and efficient manner and continuously improved.
Role type
Visual Inspection Subject Matter Expert (SME)
Builds
Visual inspection processes for injectable treatments
Domain
Pharmaceutical manufacturing (sterile)
Required skills
GMP compliance (EU GMP, Annex 1, Data Integrity), root cause analysis, CAPA, risk assessments (FMEA), statistics/SPC, Minitab/JMP, MES/ERP (SAP/BC), eQMS, VI systems (lighting/optical technology), container/closure systems knowledge, aseptic processing
Preferred skills
None stated
Technologies
Minitab, JMP, SAP, BC, eQMS
Responsibilities
Drive deviation and trend analyses, standardize workflows, increase inspection robustness, train operators, create and maintain testsets and defect libraries, handle document management, support New Product Introductions (NPI), act as deputy to release preparation of batches
Seniority
Senior, hands-on IC
