Job Opportunity:
We are seeking a highly skilled QA Validation Engineer to coordinate and implement our site validation program, ensuring compliance with regulatory requirements.
This role involves overseeing validation activities for equipment, utilities, processes, and software, as well as participating in Quality Assurance initiatives that drive business growth and excellence.
Key Responsibilities
* Coordinate and direct validation and quality assurance activities to ensure seamless project execution.
* Ensure compliance with FDA and European cGMP standards through meticulous planning and execution.
* Develop and execute validation plans and protocols that meet or exceed industry standards.
* Implement corrective actions through thorough validation investigations.
Responsibilities (continued)
* Document all activities per cGMP requirements, maintaining accurate records for auditing purposes.
* Update procedures to reflect current best practices, staying ahead of industry trends.
* Complete required training before performing tasks, ensuring expertise in relevant areas.
Requirements
* Qualification in engineering or a scientific discipline is essential for this role.
* 3+ years of validation or quality experience in medical device plastics processing is preferred.
* Strong communication and interpersonal skills are crucial for success in this position.