
Senior Validation Specialist
1 week ago
Role Overview
The primary objective of this QA Validation Engineer position is to oversee the development and maintenance of a comprehensive site validation program for an esteemed client.
Key Responsibilities:
- Coordinate, direct and participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
- Generate, maintain and execute Site Validation Master Plans, Project Validation Plans and schedules.
- Develop and finalize reports, investigations and implementation of corrective actions to cGMP standards.
- Maintain and track validation equipment, document activities in line with cGMP requirements and ensure overall cGMP compliance of production areas.
Candidates should possess a Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline, coupled with over 3 years' experience in Validation Engineering.
Essential Skills:
- Excellent collaboration and communication skills
- Strong attention to detail
- Thorough understanding of validation concepts and documentation
- Able to solve complex technical & equipment qualification challenges using a rational scientific approach
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