Senior Validation Specialist
1 month ago
As a Senior Validation Specialist at Proclinical Staffing, you will play a crucial role in supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment.
Key Responsibilities:- Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry standards.
- Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented.
- Collaborate with cross-functional teams to ensure alignment and effective implementation of validation strategies.
- Stay up-to-date with current regulatory requirements and industry standards related to validation activities.
- Contribute to the development of quality risk assessments and validation plans.
Requirements:
- Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
- Knowledge of current regulatory requirements and industry standards related to validation activities.
- Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
About Proclinical Staffing:
Proclinical Staffing is a leading provider of staffing solutions for the life sciences industry. We are committed to delivering exceptional service and supporting our clients' goals.
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