Job Overview
We are seeking a highly skilled Quality Assurance Specialist to support our validation activities. This role involves ensuring the quality and reliability of our products and processes.
Key Responsibilities:
* Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements.
* Implement solutions to sustain and improve our Quality Management System (QMS).
* Maintain compliance to ISO standards and participate in site change control.
* Generate risk assessments, covering cleaning, validation, and process.
* Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
* Support Good Manufacturing Practice (GMP) and regulatory audits.
* Prepare and deliver training modules as required.
* Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
* Contribute to continuous improvement through Lean Six Sigma methodologies.
About Our Ideal Candidate
We are looking for a highly organized individual with excellent analytical skills. The ideal candidate should have experience in process validation, quality management, and compliance to ISO standards.