Senior/ QA Validation Executive (1- Year Contract)
Core
Lead QA validation activities for new product introductions and transfers, ensuring compliance with quality systems and patient safety.
Role type
Senior QA Validation Executive
Builds
Compliant pharmaceutical supply through validated processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, validation strategy execution, regulatory compliance (21 CFR Part 11, ICH), deviation/CAPA assessment, SOP authoring, cross-functional collaboration
Preferred skills
Computerized system validation, new product introduction strategy, continuous process verification, audit processes
Technologies
GxP Regulations, Digital Fluency, Technical Writing
Responsibilities
Provide QA oversight for cleaning and process validation; Author and approve validation plans, protocols, and reports; Assess validation impact for changes and deviations; Act as QA approver for deviations and change controls; Provide subject-matter expertise to cross-functional teams; Support product submission documentation
Seniority
Senior, hands-on IC