
Quality Assurance Validator Position
1 week ago
We are seeking a highly skilled Quality Assurance Validator to join our team and play a pivotal role in ensuring the development and maintenance of our site validation program aligns with regulatory, quality, and compliance requirements.
Responsibilities:- Coordinate and participate in the site Validation Program and general Quality Assurance activities
- Direct and participate in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards
- Develop and execute Site Validation Master Plans, Project Validation Plans, and schedules
- Generate validation protocols and final reports to cGMP standards, validation investigations, and corrective actions
- Manage quality documents and test data; oversee validation, exception event, and change control processes
- A degree in engineering or scientific discipline is essential
- At least 3 years of experience in medical device validation/Quality assurance, specifically plastics processing, moulding, or assembly operations
- Substantial knowledge of cGMP and regulatory requirements for the medical device industry
- Possess strong communication, presentation, and troubleshooting skills
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