Site Validation Specialist
We are seeking an experienced Site Validation Specialist to join our team. In this role, you will be responsible for coordinating, implementing and maintaining the site validation program to ensure compliance with external regulatory requirements and industry best practices.
Main Responsibilities:
* Validation & Quality Assurance
* Coordinate, direct and actively participate in validation and QA activities for site equipment, utilities, processes and software.
* Ensure compliance with FDA, European cGMP and GAMP standards.
* Develop, maintain and execute the Site Validation Master Plan and Project Validation Plans.
* Generate validation protocols, reports and investigations to meet cGMP standards.
* Implement corrective actions as identified through validation investigations.
Documentation & Compliance:
* Create, review and approve quality documents and test data.
* Manage validation, exception events and change control processes.
* Maintain validation equipment records and ensure accurate tracking.
* Document all activities per cGMP requirements and update procedures to reflect current best practices.
Training & Continuous Improvement:
* Complete all required training before performing tasks.
* Cross-train within the team and support onboarding of new team members.
* Participate in continuous improvement initiatives across manufacturing, quality, safety and training systems.
Communication & Team Collaboration:
* Coordinate team activities for maximum efficiency.
* Maintain overall cGMP compliance in production areas.
* Communicate effectively with peers and management, escalating issues as needed.
To succeed in this role, you should have a degree in Engineering or a scientific discipline and at least 3 years' experience in medical device plastics processing, moulding or assembly operations, with knowledge of cGMP and regulatory requirements for the medical device industry.
Benefits:
* Further education opportunities
* Award-winning company culture
About Us:
This is a fantastic opportunity to work with a leading manufacturer of medical devices and to contribute to the development of innovative products that improve people's lives.