0-2 year experience in Medical Device/Pharma industry.

Job Responsibility

Monitoring of qualification and validation activities.
Preparation of technical files and related documentation.
Preparation and review of qualification & validation protocols and reports.
Review of raw data, including analytical reports, BMRs, job cards, batch release certificates, data mapping reports, etc.
Support validation activities across multiple manufacturing segments

Requirements

Qualification & Validation (IQ/OQ/PQ)

Technical Documentation & Technical File Preparation

Protocol and Report Preparation & Review

Data Review & Documentation Verification

GMP Compliance & Regulatory Documentation

Batch Manufacturing Records (BMR) & Analytical Report Review

Cross-functional Coordination & Validation Support

Erforderliche Kompetenzen

Qualification and Validation (IQ/OQ/PQ)Qualification and Validation Activity MonitoringTechnical File PreparationTechnical Documentation PreparationValidation Protocol Preparation and ReviewValidation Report Preparation and ReviewRaw Data Review and Documentation VerificationGMP Compliance and Regulatory DocumentationBatch Manufacturing Record (BMR) ReviewAnalytical Report ReviewCross-functional Coordination and Validation Support

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