Quality Assurance Specialist
2 weeks ago
We are seeking an experienced Quality Assurance Professional to play a key role in the development and upkeep of our site validation programme, ensuring all regulatory, quality, and compliance requirements are met.
Responsibilities:- Coordinate, oversee, and participate in the validation and QA of site equipment, utilities, processes, and software in compliance with FDA, European cGMP, and GAMP standards.
- Develop, maintain, and execute the Site Validation Master Plan.
- Develop, maintain, and execute project validation plans and schedules.
- Prepare validation protocols and final reports to cGMP standards.
- Conduct validation investigations and implement corrective actions.
- Create, review, and approve quality documents and test data.
- Manage validation, exception event, and change control processes.
- Maintain and track validation equipment, where applicable.
- Complete all required training before performing any task.
- Document all activities in line with cGMP requirements.
- Update validation procedures, work instructions, and batch documentation to reflect best practices.
- Provide cross-training within the team and support the training of new members.
- Participate in continuous improvement initiatives for manufacturing, quality, safety, and training systems.
- Coordinate activities to maximise team effectiveness.
- Ensure overall cGMP compliance within production areas.
- Communicate with peers and management, escalating events or concerns where necessary.
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Quality Assurance Specialist
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