Key Position: QA Validation Engineer
We are seeking a skilled professional to play a key role in the development and upkeep of our site validation program, ensuring all regulatory, quality, and compliance requirements are met.
Key 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.
* 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.
Requirements:
* Qualification and/or degree in an engineering or scientific discipline.
* 3+ years' validation or quality experience in medical device plastics processing, moulding, or assembly operations.
* 3+ years' knowledge of cGMP and regulatory requirements relating to the medical device industry.
* Strong written and verbal communication, presentation, and troubleshooting skills.
* Effective interpersonal and organisational abilities.
* Able to work both independently and as part of a team.
* Capable of prioritising tasks and managing multiple responsibilities simultaneously.
About this role:
This is an exciting opportunity to join our organisation and contribute to the success of our site validation program.
What we offer:
A dynamic working environment, opportunities for career growth and development, and a competitive remuneration package.