Job Title: QA Validation Specialist
We are seeking a skilled QA Validation Specialist to join our client on a contract basis and play a key role in ensuring site-wide validation and regulatory compliance.
About the Role:
As a QA Validation Specialist, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards. This is a hands-on role that involves planning and executing validation activities, managing quality processes, and driving continuous improvement initiatives across equipment, utilities, processes, and software systems.
Key Responsibilities:
1. Develop, execute, and maintain Validation Master Plans and Project Validation Plans.
2. Prepare and execute validation protocols, reports, and investigations to cGMP standards.
3. Lead validation and quality assurance for site equipment, processes, and software.
4. Support regulatory compliance through robust documentation, audits, and process improvements.
5. Manage change control, exception events, and corrective actions.
6. Provide cross-training, mentorship, and support to team members.
7. Actively contribute to continuous improvement in manufacturing, quality, and safety systems.
Requirements:
* Degree in an engineering or scientific discipline.
* 3+ years' experience in validation/quality within medical device plastics processing, molding, or assembly operations.
* Strong knowledge of cGMP and medical device regulatory requirements.
* Excellent communication, organizational, and troubleshooting skills.
* Ability to work independently and as part of a team, with strong prioritization and multitasking skills.