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Validation - Commissioning/Qualification Specialist || Pharma Client
2 months ago
Essential Functions:
Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Support Lifecycle Document Management System
• Develops protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols
• Supervises vendors for qualification functions.
• Develops written procedures for calibration and preventive maintenance of equipment
• Supports calibration, equipment qualification and validation activities.
• Configures and documents the configuration of computerized systems
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
• Manages projects of varying scope and complexity.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
