QC Validation Analyst

Competent in all areas of the QC Associate job description
Demonstrated leadership, coaching & Training skills
Method optimisation, verification and validation competencies
Performs QC compliance gap analysis to respective monographs
Leads OOS investigations
Contributes to Root cause analysis and brainstorming activities
Demonstrated understanding of site QMS
Participates in CAPA closure & change controls
Participates in QC/Site continuous improvement programmes
Excellent report writing and risk assessments
Deputises for Team Leaders
Reviews validation, stability and risk assessment reports
Prepare or review required method transfer documentation including technical transfer protocols or reports.
Represents QC to internal or external stakeholders e.g. Production, R&D, PMO etc.
Contributes to QC deliverables for NPD projects
Leads team planning and key QC systems compliance
Implements CI and CAPA projects
Leads audit readiness walk round and correction actions
Able to front or support during regulatory and customer audits

QC Validation Analysts must also be able to demonstrate the following abilities:

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